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

• ClinicalTrials.gov Identifier: NCT03450772
• Recruitment Status: Recruiting
• First Posted: March 1, 2018
• Last Update Posted: November 24, 2021
• Sponsor: Abbott
• Information provided by (Responsible Party): Abbott

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pancreatic Insufficiency	Drug: Creon® 25000; Drug: Creon® 10000	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: August 31, 2017
• Estimated Primary Completion Date: April 2022
• Estimated Study Completion Date: April 30, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Coefficient of fat absorption [ Time Frame: 5 days ]

Secondary Outcome Measures :

1. fat intake - fat excretion/fat intake x 100 [ Time Frame: 5 days ]
2. stool weight [ Time Frame: 5 days ]
3. Clinical symptomatology [ Time Frame: 5 days and 24 weeks ]
   stool frequency, stool consistency, abdominal pain, flatulence
4. Subject's acceptance of treatment and preference [ Time Frame: 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Suntje Sander, PhD; +495116750 ext 3254; suntje.sander@abbott.com

Locations

China

Shanghai Changhai Hospital; Recruiting

Shanghai, China

Contact: Li Zhaoshen, Prof

Sponsors and Collaborators

Abbott

More Information

• Responsible Party: Abbott
• ClinicalTrials.gov Identifier: NCT03450772
• Other Study ID Numbers: PANC3016
• First Posted: March 1, 2018
• Last Update Posted: November 24, 2021
• Last Verified: November 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Exocrine Pancreatic Insufficiency; Pancreatic Diseases; Digestive System Diseases; Pancrelipase; Pancreatin; Gastrointestinal Agents