Status:
COMPLETED
Efficacy of Pancrelipase on Postprandial Belching and Bloating.
Lead Sponsor:
Solvay Pharmaceuticals
Conditions:
Postprandial Bloating
Postprandial Belching
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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 identica...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2000
Trial Type :
INTERVENTIONAL
End Date :
October 1 2000
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00266721
Start Date
January 1 2000
End Date
October 1 2000
Last Update
December 19 2005
Active Locations (1)
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1
VAMC
Minneapolis, Minnesota, United States, 55417