Equivalence Study to Compare Two Strengths of Creon in China

NCT ID: NCT03450772

Last Updated: 2021-11-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-31
• Study Completion Date: 2022-04-30

Brief 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.

Conditions

Pancreatic Insufficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Creon® 25000 then Creon® 10000

Pancreatic enzyme

Group Type: EXPERIMENTAL

Creon® 25000

Intervention Type: DRUG

Experimental drug

Creon® 10000 then Creon® 25000

Pancreatic enzyme

Group Type: ACTIVE_COMPARATOR

Creon® 10000

Intervention Type: DRUG

Active comparator

Interventions

Creon® 25000

Experimental drug

Intervention Type: DRUG

Creon® 10000

Active comparator

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai Changhai Hospital

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Suntje Sander, PhD

Role: CONTACT

Phone: +495116750

Email: suntje.sander@abbott.com

Facility Contacts

Li Zhaoshen, Prof

Role: primary

Other Identifiers

PANC3016

Identifier Type: -

Identifier Source: org_study_id