Efficacy of Pancrelipase on Postprandial Belching and Bloating.

Phase 3

Completed

• Conditions: Postprandial Bloating; Postprandial Belching; Postprandial Eructation

• Registration Number: NCT00266721
• Lead Sponsor: Solvay Pharmaceuticals

Brief Summary

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

Study Timeline

• Study Start: 2000-01
• Study Completion: 2000-10
• Status Verified: 2000-12
• Study First Submitted: 2005-12-15
• Study First Submitted QC: 2005-12-15
• Last Update Submitted: 2005-12-15
• Study First Posted: 2005-12-19
• Last Update Posted: 2005-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Abdominal bloating
Abdominal pain
Eructation

Trial Locations

Locations (1)

VAMC; 🇺🇸 Minneapolis, Minnesota, United States