Equivalence Study to Compare Two Strengths of Creon in China (CREON)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pancreatic Insufficiency
• Intervention / Treatment: Drug: Creon® 25000; Drug: Creon® 10000

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Suntje Sander, PhD; Phone Number: 3254 +495116750; Email: suntje.sander@abbott.com

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Shanghai Changhai Hospital
    • Contact: Li Zhaoshen, Prof

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Creon® 25000 then Creon® 10000; Pancreatic enzyme	Drug: Creon® 25000; Experimental drug
Active Comparator: Creon® 10000 then Creon® 25000; Pancreatic enzyme	Drug: Creon® 10000; Active comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Coefficient of fat absorption	5 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
fat intake - fat excretion/fat intake x 100		5 days
stool weight		5 days
Clinical symptomatology	stool frequency, stool consistency, abdominal pain, flatulence	5 days and 24 weeks
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

Collaborators and Investigators

• Sponsor: Abbott

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2017
• Primary Completion (Anticipated): April 1, 2022
• Study Completion (Anticipated): April 30, 2022

Study Registration Dates

• First Submitted: February 15, 2018
• First Submitted That Met QC Criteria: February 23, 2018
• First Posted (Actual): March 1, 2018

Study Record Updates

• Last Update Posted (Actual): November 24, 2021
• Last Update Submitted That Met QC Criteria: November 23, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases; Exocrine Pancreatic Insufficiency; Gastrointestinal Agents; Pancrelipase; Pancreatin
• Other Study ID Numbers: PANC3016

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No