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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00705978
Other study ID # S245.4.009
Secondary ID
Status Completed
Phase Phase 3
First received June 26, 2008
Last updated August 16, 2011
Start date June 2008
Est. completion date May 2010

Study information

Verified date August 2011
Source Abbott
Contact n/a
Is FDA regulated No
Health authority India: Ministry of Health
Study type Interventional

Clinical Trial Summary

This study will provide efficacy data for Creon 40,000 in CP subjects as well as long-term safety data. During the long-term treatment with Creon 40,000 nutritional parameters will be assessed and correlated with CFA.


Recruitment information / eligibility

Status Completed
Enrollment 62
Est. completion date May 2010
Est. primary completion date May 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria

- Pancreatic exocrine insufficiency has to be proven (in medical history) by a pancreatic function test

- Chronic pancreatitis has to be proven (in medical history) by CT, ERCP, plain film with pancreatic calcifications, ultrasonography (calcifications,duct dilatation) and /or histology

- Females must be non-lactating and either be of non-childbearing potential or if of childbearing potential, agree to practice effective barrier contraceptive methods, use an intrauterine device (IUD) or use birth control pills or equivalent injectable contraceptive. The subject must have been practicing the selected method of birth control for at least 3 months prior to Visit 1 (Day -14).

- Subjects with a pathological stool fat during run in period (> 10g/24 h)

Exclusion Criteria

- Ileus or acute abdomen

- Any type of malignancy involving the digestive tract in the last 5 years

- Presence of pseudo pancreatic cysts >= 4 cm

- Current excessive intake of alcohol or drug abuse

- Hypersensitivity vs porcine proteins / pancreatin

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Pancreatin
Pancreatin with 40000 lipase units per capsule, 2 capsules per main meal (3 main meals) plus 1 capsule per snack (2-3 snacks)
Placebo
placebo

Locations

Country Name City State
India Site Reference ID/Investigator# 45389 Bangalore
India Site Reference ID/Investigator# 45396 Bhopal
India Site Reference ID/Investigator# 45390 Chennai
India Site Reference ID/Investigator# 54382 Cochin
India Site Reference ID/Investigator# 45391 Hyderabad
India Site Reference ID/Investigator# 45388 Jaipur
India Site Reference ID/Investigator# 45387 Kolkatta
India Site Reference ID/Investigator# 45383 Mumbai
India Site Reference ID/Investigator# 45382 Pune
India Site Reference ID/Investigator# 45395 Pune
India Site Reference ID/Investigator# 45393 Trivandrum

Sponsors (2)

Lead Sponsor Collaborator
Abbott Products Datamap

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in CFA from baseline to the end of double blind treatment 7 days after baseline No
Secondary CNA, stool fat, stool weight, nutritional, clinical symptomatology, SF-36, BMI 7 days after baseline, and end of open-label period (1 year of open label treatment) No
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