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The Effects of Tegaserod on Mechanical Sensitivity of the Esophagus and Stomach in Patients With Heartburn and Dyspepsia.

NCT ID: NCT00171457

Last Updated: 2007-10-10

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

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2006-09-30

Brief Summary

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Investigate the role of tegaserod in modulating gastric sensitivity to mechanical distention of the stomach

Detailed Description

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Conditions

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Heartburn Dyspepsia

Keywords

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functional heartburn dyspepsia male female visceral sensitivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Tegaserod

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female subjects at least 18 years of age.
* Subjects willing to undergo multiple nasogastric intubations.
* Patients with functional heartburn will need to meet ROME II criteria.
* Patients with symptoms consistent with dyspepsia (epigastric pain/discomfort characterized by bloating, postprandial fullness and early satiety)

Exclusion Criteria

* Subjects with clinically significant diarrhea or a diagnosis of diarrhea-predominant IBS.
* Subjects with a diagnosis of IBD, Barrett's esophagus, esophageal stricture or ring, or previous or current history of ulcer disease.
* Subjects with Diffuse Esophageal Spasm or Achalasia.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Principal Investigators

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Novartis

Role: STUDY_DIRECTOR

Novartis

Locations

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Oklahoma Foundation for Digestive Research

Oklahoma City, Oklahoma, United States

Site Status

Countries

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United States

References

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Miner PB Jr, Rodriguez-Stanley S, Proskin HM, Kianifard F, Bottoli I. Tegaserod in patients with mechanical sensitivity and overlapping symptoms of functional heartburn and functional dyspepsia. Curr Med Res Opin. 2008 Aug;24(8):2159-72. doi: 10.1185/03007990802222832. Epub 2008 Jun 17.

Reference Type DERIVED
PMID: 18561877 (View on PubMed)

Other Identifiers

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CHTF919DUS45

Identifier Type: -

Identifier Source: org_study_id