Skip to main content
OpenTrials
Completed

NCT Number: NCT00705978

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pancreatic Insufficiency Digestive System Diseases Exocrine Pancreatic Insufficiency Pancreatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Site Reference ID/Investigator# 45389, Bangalore, India

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pancreatin

Drug

Pancreatin with 40000 lipase units per capsule, 2 capsules per main meal (3 main meals) plus 1 capsule per snack (2-3 snacks)

Placebo

Drug

placebo

Primary outcomes

  1. Change in CFA from baseline to the end of double blind treatment

    Time frame: 7 days after baseline

Secondary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Abbott Products

Industry

Collaborators

  • Datamap

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jun 27, 2008
Registry last updated
Aug 18, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.