Equivalence Study to Compare Two Strengths of Creon in China

Pancreatic Insufficiency Clinical Trial

— CREON  

Official title:

Open-label, Multicenter, Randomized, Cross-Over, Equivalence Study to Compare the Efficacy and Safety of Two Strengths of Pancreatin Enteric-Coated Capsules in Pancreatic Exocrine Insufficiency in Chinese Subjects

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03450772
• Other study ID #: PANC3016
• Status: Recruiting
• Phase: Phase 3
• Start date: August 31, 2017
• Est. completion date: April 30, 2022

Study information

• Verified date: November 2021
• Source: Abbott
• Contact: Suntje Sander, PhD
• Phone: +495116750
• Email: suntje.sander[@]abbott.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This will be an open-label, randomized, multicenter, cross-over study in 60 subjects with PEI delivering data of 60 subjects for Pancreatin Enteric-Coated Capsules 25000 and of 60 subjects for Pancreatin Enteric-Coated Capsules 10000. The study will be conducted in up to 10 sites in China.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 30, 2022
• Est. primary completion date: April 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Signed informed consent

• Subjects = 18 years

• A) Chronic pancreatitis must be documented in the medical file by at least one of the following methods:

• Imaging techniques (ultrasound, CT, MRI, or endoscopic ultrasound)

• ERCP (endoscopic retrograde cholangiopancreatography)

• Plain film of the abdomen with pancreatic calcification or

• B) Partial or total pancreatectomy = 30 days prior to enrollment and without current postsurgery complications

• PEI proven by human fecal elastase = 100 µg/g stool (during the screening period)

• Subjects without Creon (Pancreatin Enteric Coated Minimicrospheres) intake in the past three months

• Females of child-bearing potential should agree to continue using a medically acceptable method of birth control throughout the study and for 30 days immediately after the last dose of study drug. Medically acceptable methods of birth control include bilateral tubal ligation or the use of either a contraceptive implant, a contraceptive injection (e.g. Depo-Provera™), an intrauterine device, or an oral contraceptive taken within the past three months where the subject agrees to continue using during the study or to adopt another birth control method, or a double-barrier method which consists of a combination of any two of the following: diaphragm, cervical cap, condom, or spermicide

Exclusion Criteria:

• Subjects with a history of fibrosing colonopathy

• Solid organ transplant

• Surgery affecting the stomach or bowel, except pancreatectomy or appendectomy

• Surgery affecting the stomach or bowel, except pancreatectomy or appendectomy

• Subjects with recurrent malignant tumors of any kind

• Use of an immunosuppressive drug or chemotherapy

• Acute phase of pancreatitis

• Acute phase of pancreatitis

• Subjects who are not able or willing to ingest 90g fat/day (± 10 g fat/day) during the cross-over periods or are not willing to collect complete stools during the demarcation period.

• Subjects in an instable condition after pancreatic surgery (Karnofsky index < 70)

• Known infection with HIV

• Pregnancy or lactation

• Current excessive alcohol intake or drug abuse

• Investigational drug intake within prior 30 days

• Known allergy against pancreatin of porcine origin or to any of the excipients of Pancreatin Enteric-Coated Capsules

• Suspected non-compliance or non-cooperation

• Celiac disease, Crohn´s disease

• Ileus or acute abdomen in the medical history

• Mental disability or any other lack of fitness, in the investigator's opinion, to preclude subject's participation in or to complete the study

• Any acute or chronic disease (i.e infectious diseases) which may limit the hospitalization, dietary adherence or stool collection or completion of the study procedures

Related Conditions & MeSH terms

• Exocrine Pancreatic Insufficiency
• Pancreatic Insufficiency

Intervention

Drug:
• Creon® 25000
Experimental drug
• Creon® 10000
Active comparator

Locations

Country	Name	City	State
China	Shanghai Changhai Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Coefficient of fat absorption		5 days
Secondary	fat intake - fat excretion/fat intake x 100		5 days
Secondary	stool weight		5 days
Secondary	Clinical symptomatology	stool frequency, stool consistency, abdominal pain, flatulence	5 days and 24 weeks
Secondary	Subject's acceptance of treatment and preference	Subject's acceptance of treatment will be judged based on the following scale: very good, good, moderate and unsatisfactory.; Which treatment did you prefer? No difference between treatment 1 and treatment 2 Treatment 1 is better than treatment 2 Treatment 2 is better than treatment 1	5 days and 24 weeks