Equivalence Study to Compare Two Strengths of Creon in China

Phase 3

• Conditions: Pancreatic Insufficiency
• Interventions: Drug: Creon® 25000; Drug: Creon® 10000

• Registration Number: NCT03450772
• Lead Sponsor: Abbott

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-31
• Study First Submitted: 2018-02-15
• Study First Submitted QC: 2018-02-23
• Study First Posted: 2018-03-01
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-23
• Last Update Posted: 2021-11-24
• Primary Completion: 2022-04
• Study Completion: 2022-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Creon® 25000 then Creon® 10000	Creon® 25000	Pancreatic enzyme
Creon® 10000 then Creon® 25000	Creon® 10000	Pancreatic enzyme

Primary Outcome Measures

Name	Time	Method
Coefficient of fat absorption	5 days

Secondary Outcome Measures

Name	Time	Method
stool weight	5 days
Clinical symptomatology	5 days and 24 weeks	stool frequency, stool consistency, abdominal pain, flatulence
fat intake - fat excretion/fat intake x 100	5 days
Subject's acceptance of treatment and preference	5 days and 24 weeks	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

Trial Locations

Locations (1)

Shanghai Changhai Hospital; 🇨🇳 Shanghai, China