Creon 40,000 for Treatment of PEI (Pancreatic Exocrine Insufficiency) Due to Chronic Pancreatitis

August 16, 2011 updated by: Abbott Products

A One Week Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multi-Center Study With Creon 40,000 MMS in Subjects With Pancreatic Exocrine Insufficiency Due to Chronic Pancreatitis, Followed by an Open-Label Long-Term Extension

This study will provide efficacy data for Creon 40,000 in CP subjects as well as long-term safety data. During the long-term treatment with Creon 40,000 nutritional parameters will be assessed and correlated with CFA.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Bangalore, India, 560017
        • Site Reference ID/Investigator# 45389
      • Bhopal, India, 462 016
        • Site Reference ID/Investigator# 45396
      • Chennai, India, 600096
        • Site Reference ID/Investigator# 45390
      • Cochin, India, 682304
        • Site Reference ID/Investigator# 54382
      • Hyderabad, India, 500082
        • Site Reference ID/Investigator# 45391
      • Jaipur, India, 302001
        • Site Reference ID/Investigator# 45388
      • Kolkatta, India, 700054
        • Site Reference ID/Investigator# 45387
      • Mumbai, India, 400012
        • Site Reference ID/Investigator# 45383
      • Pune, India, 411 004
        • Site Reference ID/Investigator# 45382
      • Pune, India, 411013
        • Site Reference ID/Investigator# 45395
      • Trivandrum, India, 695607
        • Site Reference ID/Investigator# 45393

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  • Pancreatic exocrine insufficiency has to be proven (in medical history) by a pancreatic function test
  • Chronic pancreatitis has to be proven (in medical history) by CT, ERCP, plain film with pancreatic calcifications, ultrasonography (calcifications,duct dilatation) and /or histology
  • Females must be non-lactating and either be of non-childbearing potential or if of childbearing potential, agree to practice effective barrier contraceptive methods, use an intrauterine device (IUD) or use birth control pills or equivalent injectable contraceptive. The subject must have been practicing the selected method of birth control for at least 3 months prior to Visit 1 (Day -14).
  • Subjects with a pathological stool fat during run in period (> 10g/24 h)

Exclusion Criteria

  • Ileus or acute abdomen
  • Any type of malignancy involving the digestive tract in the last 5 years
  • Presence of pseudo pancreatic cysts >= 4 cm
  • Current excessive intake of alcohol or drug abuse
  • Hypersensitivity vs porcine proteins / pancreatin

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: 2
Drug: Placebo
placebo
EXPERIMENTAL: 1
Drug: Pancreatin
Pancreatin with 40000 lipase units per capsule, 2 capsules per main meal (3 main meals) plus 1 capsule per snack (2-3 snacks)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in CFA from baseline to the end of double blind treatment
Time Frame: 7 days after baseline
7 days after baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
CNA, stool fat, stool weight, nutritional, clinical symptomatology, SF-36, BMI
Time Frame: 7 days after baseline, and end of open-label period (1 year of open label treatment)
7 days after baseline, and end of open-label period (1 year of open label treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Products

Collaborators

Datamap

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (ACTUAL)

May 1, 2010

Study Completion (ACTUAL)

May 1, 2010

Study Registration Dates

First Submitted

June 26, 2008

First Submitted That Met QC Criteria

June 26, 2008

First Posted (ESTIMATE)

June 27, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

August 18, 2011

Last Update Submitted That Met QC Criteria

August 16, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S245.4.009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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