Efficacy of Pancrelipase on Postprandial Belching and Bloating.

Condition(s) targeted: Postprandial Bloating; Postprandial Belching; Postprandial Eructation

Intervention: Pancrelipase (Creon) 2 tablets with each meal (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Solvay Pharmaceuticals

Official(s) and/or principal investigator(s):
Michael D Levitt, MD, Principal Investigator, Affiliation: Minneapolis VAMC

The hypothesis of this study is that the administration of pancrelipase with meals will benefit symptoms of post-prandial bloating, pain and eructation.

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study

Primary outcome:

Abdominal bloating

Abdominal pain

Eructation

Detailed description: Subjects will complete a double-blind crossover study in which, for one week periods, they will receive two pancrelipase tablets with each of the three major meals or a similarly administered identical placebo. Three times daily, subjects will rate the severity of belching, epigastric discomfort, epigastric fullness, bloating, and nausea.

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Subjects will have either bothersome upper abdominal discomfort, bloating (feeling of

abdominal distention) or belching following meals for at least 12 month's duration. Subjects must have had a normal upper gastrointestinal endoscopy and/or upper GI series during the preceding three years.

Exclusion Criteria:

- Individuals with a history suggestive of organic disease such as recent weight loss,

nausea, vomiting, GERD, recent changes in bowel habits will be excluded from the study.

VAMC, Minneapolis, Minnesota 55417, United States

Starting date: January 2000
Ending date: October 2000
Last updated: December 15, 2005