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Sponsored by: |
Solvay Pharmaceuticals |
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Information provided by: | Minneapolis Veterans Affairs Medical Center |
ClinicalTrials.gov Identifier: | NCT00266721 |
The hypothesis of this study is that the administration of pancrelipase with meals will benefit symptoms of post-prandial bloating, pain and eructation.
Condition | Intervention | Phase |
---|---|---|
Postprandial Bloating Postprandial Belching Postprandial Eructation |
Drug: Pancrelipase (Creon) 2 tablets with each meal |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study |
Estimated Enrollment: | 45 |
Study Start Date: | January 2000 |
Estimated Study Completion Date: | October 2000 |
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.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | 2355 |
Study First Received: | December 15, 2005 |
Last Updated: | December 15, 2005 |
ClinicalTrials.gov Identifier: | NCT00266721 |
Health Authority: | United States: Federal Government |
Pancrelipase Abdominal bloating Abdominal pain Eructation |
Signs and Symptoms Signs and Symptoms, Digestive Abdominal Pain |
Pain Pancrelipase Eructation |
Therapeutic Uses Gastrointestinal Agents Pharmacologic Actions |