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Efficacy of Pancrelipase on Postprandial Belching and Bloating.

This study has been completed.
Information provided by:
Minneapolis Veterans Affairs Medical Center Identifier:
First received: December 15, 2005
Last updated: NA
Last verified: December 2000
History: No changes posted
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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Minneapolis Veterans Affairs Medical Center:

Primary Outcome Measures:
  • Abdominal bloating
  • Abdominal pain
  • Eructation

Estimated Enrollment: 45
Study Start Date: January 2000
Estimated Study Completion Date: October 2000
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 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   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00266721

United States, Minnesota
Minneapolis, Minnesota, United States, 55417
Sponsors and Collaborators
Solvay Pharmaceuticals
Principal Investigator: Michael D Levitt, MD Minneapolis VAMC
  More Information Identifier: NCT00266721     History of Changes
Other Study ID Numbers: 2355
Study First Received: December 15, 2005
Last Updated: December 15, 2005

Keywords provided by Minneapolis Veterans Affairs Medical Center:
Abdominal bloating
Abdominal pain

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms
Gastrointestinal Agents processed this record on September 19, 2017