Equivalence Study to Compare Two Strengths of Creon in China

NCT03450772 | Unknown Phase 3

• 1 other identifier: PANC3016
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Coefficient of fat absorption

  5 days

Secondary Outcomes (4)

• fat intake - fat excretion/fat intake x 100

  5 days

• stool weight

  5 days

• Clinical symptomatology

  5 days and 24 weeks

• Subject's acceptance of treatment and preference

  5 days and 24 weeks

Study Arms (2)

Creon® 25000 then Creon® 10000

EXPERIMENTAL

Pancreatic enzyme

Drug: Creon® 25000

Creon® 10000 then Creon® 25000

ACTIVE COMPARATOR

Pancreatic enzyme

Drug: Creon® 10000

Interventions

Creon® 25000 DRUG

Experimental drug

Creon® 25000 then Creon® 10000

Creon® 10000 DRUG

Active comparator

Creon® 10000 then Creon® 25000

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott: lead

Study Sites (1)

Shanghai Changhai Hospital

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Exocrine Pancreatic Insufficiency

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Central Study Contacts

Suntje Sander, PhD

CONTACT

+495116750; suntje.sander@abbott.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2018
• First Posted: March 1, 2018
• Study Start: August 31, 2017
• Primary Completion: April 1, 2022
• Study Completion: April 30, 2022
• Last Updated: November 24, 2021

Record last verified: 2021-11

Locations

CN (1)