Title
Efficacy of Pancrelipase on Postprandial Belching and Bloating.
Phase
Phase 3Lead Sponsor
SolvayStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Postprandial Bloating Postprandial Belching Postprandial EructationIntervention/Treatment
pancrelipase ...Study Participants
45The 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.
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.