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Efficacy of Pancrelipase on Postprandial Belching and Bloating.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00266721
First Posted: December 19, 2005
Last Update Posted: December 19, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Minneapolis Veterans Affairs Medical Center
December 15, 2005
December 19, 2005
December 19, 2005
January 2000
Not Provided
  • Abdominal bloating
  • Abdominal pain
  • Eructation
Same as current
No Changes Posted
Not Provided
Not Provided
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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
Intervention Model: Crossover Assignment
Masking: Double
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.
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00266721
2355
Not Provided
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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