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Completed

NCT Number: NCT00535756

Creon After Pancreatic Surgery

This study will provide efficacy data for Creon 25000 MMS in PS patients as well as long-term safety data. During the long-term treatment with Creon 25000 nutritional parameters will be assessed and correlated with CFA

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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 4

Primary location

Site Reference ID/Investigator# 45022, Rousse, Bulgaria

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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 the following criteria:

  • Direct or indirect pancreatic function test (except stool fat excretion) and
  • Steatorrhoea: stool fat > 15 g/day (using van de Kamer method)
  • Proven chronic pancreatitis
  • Females of child-bearing potential must agree to continue using a medically acceptable method of birth control

Exclusion criteria

  • Subjects in an unstable situation (catabolic) after pancreatic surgery
  • Ileus or acute abdomen
  • Current excessive intake of alcohol or drug abuse
  • Hypersensitivity vs porcine proteins / pancreatin
  • Subjects taking digestive enzyme preparations have to stop them before start of the run-in period

Treatment and study plan

CREON

Drug

3 capsules Creon with 25000 lipase units per main meal (3 main meals) plus 2 capsules 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 parameters, 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

  • Data Map GmbH
  • Quintiles, Inc.

Registry information

Official study title

One Week Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multi-Center Study With Creon® 25000 Minimicrospheres™ in Subjects With Pancreatic Exocrine Insufficiency After Pancreatic Surgery, Followed by an Open-Label Long-Term Extension of 1 Year

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Sep 26, 2007
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.

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