Special Investigation of LipaCreon on Long-term Use in Patients With Pancreatic Exocrine Insufficiency

Digestive System Diseases Clinical Trial

Official title:

Special Investigation of LipaCreon on Long-term Use in Patients With Pancreatic Exocrine Insufficiency Due to Chronic Pancreatitis, Pancreatectomy and Other Conditions Except Cystic Fibrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01427725
• Other study ID #: P12-894
• Status: Completed
• Start date: September 2011
• Est. completion date: April 2015

Study information

• Verified date: March 2022
• Source: Viatris Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aims at collecting the information related to the safety and effectiveness in the pancreatic exocrine insufficiency patients receiving the treatment with LipaCreon for a long term in order to evaluate the effective and safe use of LipaCreon.

Description:

Criteria for evaluation:

1. Adverse events

2. Nutritional endpoints

• BMI (height [only prior to the start of Lipacreon treatment] and weight)

• Serum total protein

• Albumin

• Total cholesterol

• Triglycerides

• Haemoglobin

3. Symptoms related to exocrine pancreatic insufficiency

• Steatorrhoea

• Frequency of bowel movements

• Diarrhoea

• Foul stool odour

• Decreased appetite

• Abdominal distension

4. Patient's quality of life (QOL)

5. Degree of general improvement

Recruitment information / eligibility

• Status: Completed
• Enrollment: 579
• Est. completion date: April 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 99 Years

Eligibility

Inclusion Criteria

• Patients who receive LipaCreon for the replacement of pancreatic digestive enzymes in pancreatic exocrine insufficiency

Exclusion Criteria

• Patients with a history of hypersensitivity to the ingredient of LipaCreon.

• Patients with a history of hypersensitivity to porcine protein.

Related Conditions & MeSH terms

• Digestive System Diseases
• Exocrine Pancreatic Insufficiency
• Gastrointestinal Diseases
• Pancreatic Diseases

Intervention

Drug:
• Lipacreon
This study was an observational study and no intervention was specified

Locations

Country	Name	City	State
Japan	Research facility ID ORG-000208	Aichi
Japan	Research facility ID ORG-000214	Aichi
Japan	Research facility ID ORG-000215	Aichi
Japan	Research facility ID ORG-000216	Aichi
Japan	Research facility ID ORG-000247	Aichi
Japan	Research facility ID ORG-000256	Aichi
Japan	Research facility ORG-000086	Aichi
Japan	Research facility ORG-000096	Aichi
Japan	Research facility ORG-000119	Aichi
Japan	Research facility ORG-000120	Aichi
Japan	Site reference ID/Investigator # 75775	Aichi
Japan	Research facility ORG-000222	Akita
Japan	Site Reference ID/Investigator# 68371	Akita
Japan	Site Reference ID/Investigator# 71098	Akita
Japan	Research facility ORG-000129	Aomori
Japan	Research facility ORG-000133	Aomori
Japan	Research facility ID ORG-000246	Chiba
Japan	Research facility ORG-000118	Chiba
Japan	Research facility ORG-000162	Chiba
Japan	Site Reference ID/Investigator# 68378	Chiba
Japan	Site Reference ID/Investigator# 75790	Chiba
Japan	site REference ID/Investigator# 75798	Chiba
Japan	Site reference ID/Investigator# 88676	Chiba
Japan	Research facility ID ORG-000232	Ehime
Japan	Research facility ID ORG-000251	Ehime
Japan	Research facility ORG-000130	Ehime
Japan	Research facility ORG-000233	Ehime
Japan	Research facility ID ORG-000271	Fukui
Japan	Site reference ID/Investigator # 88674	Fukui
Japan	Investigator ID 117496	Fukuoka
Japan	Research facility ID ORG-000229	Fukuoka
Japan	Research facility ID ORG-000262	Fukuoka
Japan	Research facility ID ORG-000269	Fukuoka
Japan	Research facility ORG-000088	Fukuoka
Japan	Research facility ORG-000091	Fukuoka
Japan	Research facility ORG-000094	Fukuoka
Japan	Research facility ORG-000098	Fukuoka
Japan	Research facility ORG-000104	Fukuoka
Japan	Research facility ORG-000114	Fukuoka
Japan	Research facility ORG-000165	Fukuoka
Japan	Research facility ID ORG-000177	Fukushima
Japan	Research facility ID ORG-000207	Fukushima
Japan	Research facility ORG-000136	Fukushima
Japan	Site Reference ID/Investigator# 84554	Fukushima
Japan	Research facility ID ORG-000238	Gifu
Japan	Site reference ID/Investigator# 91833	Gifu
Japan	Research facility ID ORG-000272	Gunma
Japan	Research facility ORG-000139	Gunma
Japan	Site reference ID/Investigator # 84557	Gunma
Japan	Research facility ID ORG-000203	Hiroshima
Japan	Research facility ID ORG-000241	Hiroshima
Japan	Research facility ORG-000155	Hiroshima
Japan	Research facility ORG-000156	Hiroshima
Japan	Site reference ID/Investigator # 91835	Hiroshima
Japan	Site Reference ID/Investigator# 84515	Hiroshima
Japan	Site Reference ID/Investigator# 88698	Hiroshima
Japan	Research facility ID ORG-000201	Hokkaido
Japan	Research facility ID ORG-000211	Hokkaido
Japan	Research facility ID ORG-000213	Hokkaido
Japan	Research facility ID ORG-000220	Hokkaido
Japan	Research facility ID ORG-000223	Hokkaido
Japan	Research facility ID ORG-000250	Hokkaido
Japan	Research facility ID/Investigator # ORG-000221 / 86896	Hokkaido
Japan	Research facility ORG-000097	Hokkaido
Japan	Research facility ORG-000140	Hokkaido
Japan	Site Reference ID# 84573	Hokkaido
Japan	Site Reference ID/Investigator# 84535	Hokkaido
Japan	Site reference ID/Investigator# 84575	Hokkaido
Japan	Research facility ID ORG-000225	Hyogo
Japan	Research facility ORG-000142	Hyogo
Japan	Research facility ORG-000152	Hyogo
Japan	Research facility ORG-000159	Hyogo
Japan	Research facility ORG-000160	Hyogo
Japan	Research facility ORG-000163	Hyogo
Japan	Site Reference ID/Investigator# 73816	Hyogo
Japan	Research facility ID ORG-000181	Ibaraki
Japan	Research facility ID ORG-000249	Ibaraki
Japan	Site Reference ID/Investigator# 75804	Ibaraki
Japan	Investigator ID 117498	Ishikawa
Japan	Site Reference ID/Investigator# 63982	Iwate
Japan	Research facility ID ORG-000260	Kagawa
Japan	Research facility ID ORG-000244	Kagoshima
Japan	Research facility ID ORG-000273	Kagoshima
Japan	Research facility ORG-000107	Kagoshima
Japan	Site reference ID/Investigator# 91860	Kagoshima
Japan	Research faciliity ORG-000099	Kanagawa
Japan	Research facility ID ORG-000167	Kanagawa
Japan	Research facility ID ORG-000182	Kanagawa
Japan	Research facility ID ORG-000191	Kanagawa
Japan	Research facility ID ORG-000202	Kanagawa
Japan	Research facility ID ORG-000212	Kanagawa
Japan	Research facility ID ORG-000254	Kanagawa
Japan	Research facility ID ORG-000255	Kanagawa
Japan	Site reference ID/Investigator # 75802	Kanagawa
Japan	Research facility ID ORG-000166	Kochi
Japan	Research facility ORG-000154	Kochi
Japan	Research facility ORG-000113	Kumamoto
Japan	Investigator ID 117503	Kyoto
Japan	Research facility ID ORG-000176	Kyoto
Japan	Research facility ID ORG-000180	Kyoto
Japan	Research facility ID ORG-000194	Kyoto
Japan	Research facility ID ORG-000196	Kyoto
Japan	Research facility ORG-000150	Kyoto
Japan	Research facility ORG-000153	Kyoto
Japan	Research faclity ORG-000112	Kyoto
Japan	Site reference ID/Investigator # 75789	Kyoto
Japan	Research facility ID ORG-000237	Mie
Japan	Research facility ORG-000105	Mie
Japan	Research facility ORG-000092	Miyagi
Japan	Research facility ORG-000093	Miyagi
Japan	Research facility ORG-000147	Miyagi
Japan	Site reference ID/Investigator # 84561	Miyagi
Japan	Site Reference ID/Investigator# 84560	Miyagi
Japan	Investigator ID 117507	Miyazaki
Japan	Investigator ID 117508	Miyazaki
Japan	Research facility ID ORG-000290	Nagano
Japan	Research facility ORG-000109	Nagano
Japan	Research facility ORG-000115	Nagano
Japan	Research facility ORG-000171	Nagano
Japan	Site reference ID/Investigator# 96736	Nagano
Japan	Research facility ORG-000137	Nagasaki
Japan	Research facility ID ORG-000265	Nara
Japan	Site reference ID/Investigator # 71102	Nara
Japan	Research facility ID ORG-000193	Niigata
Japan	Research facility ORG-000100	Niigata
Japan	Research facility ORG-000102	Niigata
Japan	Research facility ORG-000267	Niigata
Japan	Investigator ID 117497	Oita
Japan	Research facility ORG-000106	Oita
Japan	Research facility ID ORG-000231	Okayama
Japan	Research facility ORG-000268	Okayama
Japan	Site reference ID/Investigator # 91836	Okayama
Japan	Site reference ID/Investigator # 91856	Okinawa
Japan	Research facility ID ORG-000183	Osaka
Japan	Research facility ORG-000089	Osaka
Japan	Research facility ORG-000090	Osaka
Japan	Research facility ORG-000095	Osaka
Japan	Research facility ORG-000117	Osaka
Japan	Site Reference ID/Investigator# 86894	Osaka
Japan	Research facility ID ORG-000204	Saga
Japan	Research facility ID ORG-000173	Saitama
Japan	Research facility ID ORG-000189	Saitama
Japan	Research facility ID ORG-000190	Saitama
Japan	Research facility ID ORG-000199	Saitama
Japan	Research facility ORG-000135	Saitama
Japan	Research facility ORG-000143	Saitama
Japan	Research facility ORG-000157	Saitama
Japan	Research facility ORG-000172	Saitama
Japan	Site Reference ID/Investigator# 86895	Saitama
Japan	Site reference ID/Investigator# 96739	Saitama
Japan	Research facility ORG-000116	Shiga
Japan	Research facility ID ORG-000178	Shimane
Japan	Research facility ID ORG-000239	Shizuoka
Japan	Research facility ID ORG-000252	Shizuoka
Japan	Research facility ID ORG-000253	Shizuoka
Japan	Site reference ID/Investigator# 84576	Shizuoka
Japan	Site Reference ID/Investigator# 91834	Shizuoka
Japan	Research facility ORG-000108	Tochigi
Japan	Research facility ORG-000126	Tochigi
Japan	Investigator ID 117499	Tokyo
Japan	Investigator ID 117501	Tokyo
Japan	Investigator ID 117504	Tokyo
Japan	Investigator ID 117505	Tokyo
Japan	Research facility ID ORG-000179	Tokyo
Japan	Research facility ID ORG-000195	Tokyo
Japan	Research facility ID ORG-000227	Tokyo
Japan	Research facility ORG-000101	Tokyo
Japan	Research facility ORG-000103	Tokyo
Japan	Research facility ORG-000110	Tokyo
Japan	Research facility ORG-000121	Tokyo
Japan	Research facility ORG-000123	Tokyo
Japan	Research facility ORG-000124	Tokyo
Japan	Research facility ORG-000132	Tokyo
Japan	Research facility ORG-000138	Tokyo
Japan	Research facility ORG-000146	Tokyo
Japan	Research facility ORG-000151	Tokyo
Japan	Research facility ORG-000158	Tokyo
Japan	Research facility ORG-000161	Tokyo
Japan	Research facility ORG-000164	Tokyo
Japan	Site Reference ID/Investigator# 73824	Tokyo
Japan	Site Reference ID/Investigator# 75777	Tokyo
Japan	Site Reference ID/Investigator# 84578	Tokyo
Japan	Site reference ID/Investigator # 86913	Tottori
Japan	Research facility ID ORG-000243	Wakayama
Japan	Research facility ORG-000122	Yamagata
Japan	Research facility ID ORG-000263	Yamaguchi
Japan	Research facility ID ORG-000266	Yamaguchi
Japan	Research facility ORG-000128	Yamaguchi
Japan	Research facility ORG-000127	Yamanashi

Sponsors (1)

Lead Sponsor	Collaborator
Mylan Inc.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients With Adverse Drug Reaction	An adverse event (AE) was defined as any unfavourable or unintended disease, or symptom or sign of such a disease, or abnormal laboratory finding that occurred in a patient who received Lipacreon, whether or not considered related to the medicinal product. Also, an AE for which the relationship with Lipacreon could not be ruled out was regarded as an adverse drug reaction (ADR).; Related : There is a temporal relationship between the use of the medicinal product and the onset of an AE, or a relapse with readministration,where other factors are less likely to be involved.; Relationship cannot be ruled out : There are other potential factors although there is a temporal relationship between the use of the medicinal product and the onset of an AE	At week 52
Secondary	Degree of General Improvement	It was assessed at 24 weeks after the start of Lipacreon treatment and at the end of the observation period, using the following 4 grades: Improved, unchanged, exacerbated, unassessable	At week 24
Secondary	Degree of General Improvement	It was assessed at 24 weeks after the start of Lipacreon treatment and at the end of the observation period, using the following 4 grades: Improved, unchanged, exacerbated, unassessable	At week 52
Secondary	Nutritional Endpoints - BMI	The following nutritional endpoints were measured prior to the start of Lipacreon treatment, 4, 8 and 24 weeks after the start of treatment, and at the end of the observation period.; BMI (height [only prior to the start of Lipacreon treatment] and weight); Serum total protein; Albumin; Total cholesterol; Triglycerides; Haemoglobin	Baseline, 4 weeks, 8 weeks, 24 weeks, and 52 weeks
Secondary	Nutritional Endpoints - Serum Total Protein	The following nutritional endpoints were measured prior to the start of Lipacreon treatment, 4, 8 and 24 weeks after the start of treatment, and at the end of the observation period.; BMI (height [only prior to the start of Lipacreon treatment] and weight); Serum total protein; Albumin; Total cholesterol; Triglycerides; Haemoglobin	Baseline, 4 weeks, 8 weeks, 24 weeks, and 52 weeks
Secondary	Nutrition Endpoints - Albumin	The following nutritional endpoints were measured prior to the start of Lipacreon treatment, 4, 8 and 24 weeks after the start of treatment, and at the end of the observation period.; BMI (height [only prior to the start of Lipacreon treatment] and weight); Serum total protein; Albumin; Total cholesterol; Triglycerides; Haemoglobin	Baseline, 4 weeks, 8 weeks, 24 weeks, and 52 weeks
Secondary	Nutrition Endpoints - Total Cholesterol	The following nutritional endpoints were measured prior to the start of Lipacreon treatment, 4, 8 and 24 weeks after the start of treatment, and at the end of the observation period.; BMI (height [only prior to the start of Lipacreon treatment] and weight); Serum total protein; Albumin; Total cholesterol; Triglycerides; Haemoglobin	Baseline, 4 weeks, 8 weeks, 24 weeks, and 52 weeks
Secondary	Patient's Quality of Life - Physical Health (Summary)	Baseline, 8 and 24 weeks after the start of treatment, and at the end of the observation period, the patient was asked to fill out the standard SF-8™ (1 month) to assess the patient's QOL, which was recorded in the survey form for this survey. SF-8™:The Medical Outcomes Study 8-Item Short-Form Health Survey (Japanese version). Items are as follows.; Physical health (summary):PCS8, Mental health (summary):MCS8, General health:SF8GH, Physical functioning:SF8PF, Role physical:SF8RP, Body pain:SF8BP, Vitality:SF8VT, Social functioning:SF8SF, Mental health:SF8MH, Role emotional:SF8RE.; PCS8 score is calculated by the following formula (All summed). PCS8 score = (0.23024×SF8GH)+(0.40672×SF8PF)+(0.38317×SF8RP)+(0.33295×SF8BP)+(0.07537×SF8VT)+(-0.01275×SF8SF)+(-0.30469×SF8MH)+(-0.14803×SF8RE)+0.67371; The minimum value of PCS8 is 5.315, and the maximum value is 70.689. Higher scores mean a better outcome.; The means ± SD was calculated by summing the values at each time point.	Baseline, 8 weeks, 24 weeks, and 52 weeks
Secondary	Symptoms Related to Exocrine Pancreatic Insufficiency - Steatorrhoea	The following symptoms were assessed as those related to exocrine pancreatic insufficiency prior to the start of Lipacreon treatment, 4, 8 and 24 weeks after the start of treatment, and at the end of the observation period.; Steatorrhoea (Yes/No); Frequency of bowel movements (times/day); Diarrhoea (Yes/No); Foul stool odour (Yes/No); Decreased appetite (Yes/No); Abdominal distension (Yes/No)	Baseline, 4 weeks, 8 weeks, 24 weeks, and 52 weeks
Secondary	Nutrition Endpoints - Triglycerides	The following nutritional endpoints were measured prior to the start of Lipacreon treatment, 4, 8 and 24 weeks after the start of treatment, and at the end of the observation period.; BMI (height [only prior to the start of Lipacreon treatment] and weight); Serum total protein; Albumin; Total cholesterol; Triglycerides; Haemoglobin	Baseline, 4 weeks, 8 weeks, 24 weeks, and 52 weeks
Secondary	Nutrition Endpoints - Haemoglobin	The following nutritional endpoints were measured prior to the start of Lipacreon treatment, 4, 8 and 24 weeks after the start of treatment, and at the end of the observation period.; BMI (height [only prior to the start of Lipacreon treatment] and weight); Serum total protein; Albumin; Total cholesterol; Triglycerides; Haemoglobin	Baseline, 4 weeks, 8 weeks, 24 weeks, and 52 weeks
Secondary	Patient's Quality of Life - Mental Health (Summary)	Baseline, 8 and 24 weeks after the start of treatment, and at the end of the observation period, the patient was asked to fill out the standard SF-8™ (1 month) to assess the patient's QOL, which was recorded in the survey form for this survey. SF-8™:The Medical Outcomes Study 8-Item Short-Form Health Survey (Japanese version). Items are as follows.; Physical health (summary):PCS8, Mental health (summary):MCS8, General health:SF8GH, Physical functioning:SF8PF, Role physical:SF8RP, Body pain:SF8BP, Vitality:SF8VT, Social functioning:SF8SF, Mental health:SF8MH, Role emotional:SF8RE.; MCS8 score is calculated by the following formula (All summed). MCS8 score = (-0.02020×SF8GH)+(-0.19972×SF8PF)+(-0.16579×SF8RP)+(-0.15992×SF8BP)+(0.16737×SF8VT)+(0.27264×SF8SF)+(0.57583×SF8MH)+(0.42927×SF8RE)+4.34744; The minimum value of MCS8 is 10.108, and the maximum value is 74.511. Higher scores mean a better outcome.; The means ± SD was calculated by summing the values at each time point.	Baseline, 8 weeks, 24 weeks, and 52 weeks
Secondary	Patient's Quality of Life - General Health	Baseline, 8 and 24 weeks after the start of treatment, and at the end of the observation period, the patient was asked to fill out the standard SF-8™ (1 month) to assess the patient's QOL, which was recorded in the survey form for this survey. SF-8™:The Medical Outcomes Study 8-Item Short-Form Health Survey (Japanese version). Items are as follows.; Physical health (summary):PCS8, Mental health (summary):MCS8, General health:SF8GH, Physical functioning:SF8PF, Role physical:SF8RP, Body pain:SF8BP, Vitality:SF8VT, Social functioning:SF8SF, Mental health:SF8MH, Role emotional:SF8RE.; SF8GH scores; 1:63.38, 2:58.54, 3:50.27, 4:40.40, 5:34.38, 6:26.89 The minimum value of SF8GH is 26.89, and the maximum value is 63.38. Higher scores mean a better outcome.; The means ± SD was calculated by summing the values at each time point.	Baseline, 8 weeks, 24 weeks, and 52 weeks
Secondary	Patient's Quality of Life - Physical Functioning	Baseline, 8 and 24 weeks after the start of treatment, and at the end of the observation period, the patient was asked to fill out the standard SF-8™ (1 month) to assess the patient's QOL, which was recorded in the survey form for this survey. SF-8™:The Medical Outcomes Study 8-Item Short-Form Health Survey (Japanese version). Items are as follows.; Physical health (summary):PCS8, Mental health (summary):MCS8, General health:SF8GH, Physical functioning:SF8PF, Role physical:SF8RP, Body pain:SF8BP, Vitality:SF8VT, Social functioning:SF8SF, Mental health:SF8MH, Role emotional:SF8RE.; SF8PF scores; 1:53.54, 2:47.77, 3:41.45, 4:27.59, 5:16.69 The minimum value of SF8PF is 16.69, and the maximum value is 53.54. Higher scores mean a better outcome.; The means ± SD was calculated by summing the values at each time point.	Baseline, 8 weeks, 24 weeks, and 52 weeks
Secondary	Patient's Quality of Life - Role Physical	Baseline, 8 and 24 weeks after the start of treatment, and at the end of the observation period, the patient was asked to fill out the standard SF-8™ (1 month) to assess the patient's QOL, which was recorded in the survey form for this survey. SF-8™:The Medical Outcomes Study 8-Item Short-Form Health Survey (Japanese version). Items are as follows.; Physical health (summary):PCS8, Mental health (summary):MCS8, General health:SF8GH, Physical functioning:SF8PF, Role physical:SF8RP, Body pain:SF8BP, Vitality:SF8VT, Social functioning:SF8SF, Mental health:SF8MH, Role emotional:SF8RE.; SF8RP scores; 1:54.09, 2:47.42, 3:40.65, 4:27.91, 5:21.80. The minimum value of SF8RP is 21.80, and the maximum value is 54.09. Higher scores mean a better outcome.; The means ± SD was calculated by summing the values at each time point.	Baseline, 8 weeks, 24 weeks, and 52 weeks
Secondary	Patient's Quality of Life - Body Pain	Baseline, 8 and 24 weeks after the start of treatment, and at the end of the observation period, the patient was asked to fill out the standard SF-8™ (1 month) to assess the patient's QOL, which was recorded in the survey form for this survey. SF-8™:The Medical Outcomes Study 8-Item Short-Form Health Survey (Japanese version). Items are as follows.; Physical health (summary):PCS8, Mental health (summary):MCS8, General health:SF8GH, Physical functioning:SF8PF, Role physical:SF8RP, Body pain:SF8BP, Vitality:SF8VT, Social functioning:SF8SF, Mental health:SF8MH, Role emotional:SF8RE.; SF8BP scores; 1:60.35, 2:52.46, 3:46.10, 4:38.21, 5:31.59, 6:21.68. The minimum value of SF8BP is 21.68, and the maximum value is 60.35. Higher scores mean a better outcome.; The means ± SD was calculated by summing the values at each time point.	Baseline, 8 weeks, 24 weeks, and 52 weeks
Secondary	Patient's Quality of Life - Vitality	Baseline, 8 and 24 weeks after the start of treatment, and at the end of the observation period, the patient was asked to fill out the standard SF-8™ (1 month) to assess the patient's QOL, which was recorded in the survey form for this survey. SF-8™:The Medical Outcomes Study 8-Item Short-Form Health Survey (Japanese version). Items are as follows.; Physical health (summary):PCS8, Mental health (summary):MCS8, General health:SF8GH, Physical functioning:SF8PF, Role physical:SF8RP, Body pain:SF8BP, Vitality:SF8VT, Social functioning:SF8SF, Mental health:SF8MH, Role emotional:SF8RE.; SF8VT scores; 1:60.01, 2:53.74, 3:44.48, 4:38.51, 5:28.68. The minimum value of SF8VT is 28.68, and the maximum value is 60.01. Higher scores mean a better outcome.; The means ± SD was calculated by summing the values at each time point.	Baseline, 8 weeks, 24 weeks, and 52 weeks
Secondary	Patient's Quality of Life - Social Functioning	Baseline, 8 and 24 weeks after the start of treatment, and at the end of the observation period, the patient was asked to fill out the standard SF-8™ (1 month) to assess the patient's QOL, which was recorded in the survey form for this survey. SF-8™:The Medical Outcomes Study 8-Item Short-Form Health Survey (Japanese version). Items are as follows.; Physical health (summary):PCS8, Mental health (summary):MCS8, General health:SF8GH, Physical functioning:SF8PF, Role physical:SF8RP, Body pain:SF8BP, Vitality:SF8VT, Social functioning:SF8SF, Mental health:SF8MH, Role emotional:SF8RE.; SF8SF scores; 1:55.14, 2:45.60, 3:37.65, 4:29.15, 5:26.00. The minimum value of SF8SF is 26.00, and the maximum value is 55.14. Higher scores mean a better outcome.; The means ± SD was calculated by summing the values at each time point.	Baseline, 8 weeks, 24 weeks, and 52 weeks
Secondary	Patient's Quality of Life - Mental Health	Baseline, 8 and 24 weeks after the start of treatment, and at the end of the observation period, the patient was asked to fill out the standard SF-8™ (1 month) to assess the patient's QOL, which was recorded in the survey form for this survey. SF-8™:The Medical Outcomes Study 8-Item Short-Form Health Survey (Japanese version). Items are as follows.; Physical health (summary):PCS8, Mental health (summary):MCS8, General health:SF8GH, Physical functioning:SF8PF, Role physical:SF8RP, Body pain:SF8BP, Vitality:SF8VT, Social functioning:SF8SF, Mental health:SF8MH, Role emotional:SF8RE.; SF8MH scores; 1:56.93, 2:50.72, 3:44.94, 4:36.30, 5:27.59. The minimum value of SF8MH is 27.59, and the maximum value is 56.93. Higher scores mean a better outcome.; The means ± SD was calculated by summing the values at each time point.	Baseline, 8 weeks, 24 weeks, and 52 weeks
Secondary	Patient's Quality of Life - Role Emotional	Baseline, 8 and 24 weeks after the start of treatment, and at the end of the observation period, the patient was asked to fill out the standard SF-8™ (1 month) to assess the patient's QOL, which was recorded in the survey form for this survey. SF-8™:The Medical Outcomes Study 8-Item Short-Form Health Survey (Japanese version). Items are as follows.; Physical health (summary):PCS8, Mental health (summary):MCS8, General health:SF8GH, Physical functioning:SF8PF, Role physical:SF8RP, Body pain:SF8BP, Vitality:SF8VT, Social functioning:SF8SF, Mental health:SF8MH, Role emotional:SF8RE.; SF8RE scores; 1:54.19, 2:48.04, 3:42.24, 4:31.42, 5:19.98. The minimum value of SF8RE is 19.98, and the maximum value is 54.19. Higher scores mean a better outcome.; The means ± SD was calculated by summing the values at each time point.	Baseline, 8 weeks, 24 weeks, and 52 weeks
Secondary	Symptoms Related to Exocrine Pancreatic Insufficiency - Frequency of Bowel Movements	The following symptoms were assessed as those related to exocrine pancreatic insufficiency prior to the start of Lipacreon treatment, 4, 8 and 24 weeks after the start of treatment, and at the end of the observation period.; Steatorrhoea (Yes/No); Frequency of bowel movements (times/day); Diarrhoea (Yes/No); Foul stool odour (Yes/No); Decreased appetite (Yes/No); Abdominal distension (Yes/No)	Baseline, 4 weeks, 8 weeks, 24 weeks, and 52 weeks
Secondary	Symptoms Related to Exocrine Pancreatic Insufficiency - Diarrhoea	The following symptoms were assessed as those related to exocrine pancreatic insufficiency prior to the start of Lipacreon treatment, 4, 8 and 24 weeks after the start of treatment, and at the end of the observation period.; Steatorrhoea (Yes/No); Frequency of bowel movements (times/day); Diarrhoea (Yes/No); Foul stool odour (Yes/No); Decreased appetite (Yes/No); Abdominal distension (Yes/No)	Baseline, 4 weeks, 8 weeks, 24 weeks, and 52 weeks
Secondary	Symptoms Related to Exocrine Pancreatic Insufficiency - Foul Stool Odour	The following symptoms were assessed as those related to exocrine pancreatic insufficiency prior to the start of Lipacreon treatment, 4, 8 and 24 weeks after the start of treatment, and at the end of the observation period.; Steatorrhoea (Yes/No); Frequency of bowel movements (times/day); Diarrhoea (Yes/No); Foul stool odour (Yes/No); Decreased appetite (Yes/No); Abdominal distension (Yes/No)	Baseline, 4 weeks, 8 weeks, 24 weeks, and 52 weeks
Secondary	Symptoms Related to Exocrine Pancreatic Insufficiency - Decreased Appetite	The following symptoms were assessed as those related to exocrine pancreatic insufficiency prior to the start of Lipacreon treatment, 4, 8 and 24 weeks after the start of treatment, and at the end of the observation period.; Steatorrhoea (Yes/No); Frequency of bowel movements (times/day); Diarrhoea (Yes/No); Foul stool odour (Yes/No); Decreased appetite (Yes/No); Abdominal distension (Yes/No)	Baseline, 4 weeks, 8 weeks, 24 weeks, and 52 weeks
Secondary	Symptoms Related to Exocrine Pancreatic Insufficiency - Abdominal Distension	The following symptoms were assessed as those related to exocrine pancreatic insufficiency prior to the start of Lipacreon treatment, 4, 8 and 24 weeks after the start of treatment, and at the end of the observation period.; Steatorrhoea (Yes/No); Frequency of bowel movements (times/day); Diarrhoea (Yes/No); Foul stool odour (Yes/No); Decreased appetite (Yes/No); Abdominal distension (Yes/No)	Baseline, 4 weeks, 8 weeks, 24 weeks, and 52 weeks