Efficacy of Pancrelipase on Postprandial Belching and Bloating.

Solvay

Status and phase

Completed

Phase 3

Conditions

Postprandial Belching

Postprandial Eructation

Postprandial Bloating

Treatments

Drug: Pancrelipase (Creon) 2 tablets with each meal

Study type

Interventional

Funder types

Industry

Identifiers

NCT00266721

2355

Details and patient eligibility

About

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

Full 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.

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.