Efficacy of Pancrelipase on Postprandial Belching and Bloating.

Solvay Pharmaceuticals45 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Postprandial Bloating Postprandial Belching Postprandial Eructation

Interventions

Pancrelipase (Creon) 2 tablets with each mealDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

VAMC

Minneapolis, Minnesota, United States

Outcomes

Primary Outcomes

Abdominal bloating

Abdominal pain

Eructation

Data from ClinicalTrials.gov

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