Efficacy of Pancrelipase on Postprandial Belching and Bloating.

This study has been completed.

First Received on December 15, 2005. No Changes Posted

Sponsor:	Solvay Pharmaceuticals
Information provided by:	Minneapolis Veterans Affairs Medical Center
ClinicalTrials.gov Identifier:	NCT00266721

Purpose

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 III

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

Resource links provided by NLM:

MedlinePlus related topics: Abdominal Pain Gas

Drug Information available for: Pancrelipase Ultrase

U.S. FDA Resources

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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00266721

Locations

United States, Minnesota
VAMC
Minneapolis, Minnesota, United States, 55417

Sponsors and Collaborators

Solvay Pharmaceuticals

Investigators

Principal Investigator:

Michael D Levitt, MD

Minneapolis VAMC

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00266721 History of Changes
Other Study ID Numbers:	2355
Study First Received:	December 15, 2005
Last Updated:	December 15, 2005
Health Authority:	United States: Federal Government

Keywords provided by Minneapolis Veterans Affairs Medical Center:

Pancrelipase
Abdominal bloating
Abdominal pain
Eructation

Additional relevant MeSH terms:

Eructation
Signs and Symptoms, Digestive
Signs and Symptoms
Pancrelipase

Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012