Efficacy of Pancrelipase on Postprandial Belching and Bloating.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-01-31

Study Completion Date

2000-10-31

Brief Summary

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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

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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.

Conditions

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Postprandial Bloating Postprandial Belching Postprandial Eructation

Keywords

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Pancrelipase Abdominal bloating Abdominal pain Eructation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Pancrelipase (Creon) 2 tablets with each meal

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Michael D Levitt, MD

Role: PRINCIPAL_INVESTIGATOR

Minneapolis VAMC

Locations

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VAMC

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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2355

Identifier Type: -

Identifier Source: org_study_id