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

Tracking Information

First Received Date ^ICMJE

December 15, 2005

Last Updated Date

December 15, 2005

Start Date ^ICMJE

January 2000

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Abdominal bloating
Abdominal pain
Eructation

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Efficacy of Pancrelipase on Postprandial Belching and Bloating.

Official Title ^ICMJE

Not Provided

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 identical placebo. Three times daily, subjects will rate the severity of belching, epigastric discomfort, epigastric fullness, bloating, and nausea.

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Postprandial Bloating
Postprandial Belching
Postprandial Eructation

Intervention ^ICMJE

Drug: Pancrelipase (Creon) 2 tablets with each meal

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

October 2000

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00266721

Other Study ID Numbers ^ICMJE

2355

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Solvay Pharmaceuticals

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Michael D Levitt, MD

Minneapolis VAMC

Information Provided By

Minneapolis Veterans Affairs Medical Center

Verification Date

December 2000

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

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