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Efficacy of Pancrelipase on Postprandial Belching and Bloating.

This study has been completed.
Sponsor:
Information provided by:
Minneapolis Veterans Affairs Medical Center
ClinicalTrials.gov Identifier:
NCT00266721
First received: December 15, 2005
Last updated: NA
Last verified: December 2000
History: No changes posted

December 15, 2005
December 15, 2005
January 2000
Not Provided
  • Abdominal bloating
  • Abdominal pain
  • Eructation
Same as current
No Changes Posted
Not Provided
Not Provided
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Not Provided
 
Efficacy of Pancrelipase on Postprandial Belching and Bloating.
Not Provided

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Postprandial Bloating
  • Postprandial Belching
  • Postprandial Eructation
Drug: Pancrelipase (Creon) 2 tablets with each meal
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
October 2000
Not Provided

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.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00266721
2355
Not Provided
Not Provided
Solvay Pharmaceuticals
Not Provided
Principal Investigator: Michael D Levitt, MD Minneapolis VAMC
Minneapolis Veterans Affairs Medical Center
December 2000

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP