Efficacy of Pancrelipase on Postprandial Belching and Bloating.

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. Identifier: NCT00266721
Recruitment Status : Completed
First Posted : December 19, 2005
Last Update Posted : December 19, 2005
Information provided by:
Minneapolis Veterans Affairs Medical Center

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.

Condition or disease Intervention/treatment Phase
Postprandial Bloating Postprandial Belching Postprandial Eructation Drug: Pancrelipase (Creon) 2 tablets with each meal Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Study Start Date : January 2000
Study Completion Date : October 2000

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gas
U.S. FDA Resources

Primary Outcome Measures :
  1. Abdominal bloating
  2. Abdominal pain
  3. Eructation

Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00266721

United States, Minnesota
Minneapolis, Minnesota, United States, 55417
Sponsors and Collaborators
Solvay Pharmaceuticals
Principal Investigator: Michael D Levitt, MD Minneapolis VAMC Identifier: NCT00266721     History of Changes
Other Study ID Numbers: 2355
First Posted: December 19, 2005    Key Record Dates
Last Update Posted: December 19, 2005
Last Verified: December 2000

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