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Assessment of Efficacy and Safety of Tegaserod Treatment and Placebo in Women With Dyspepsia

NCT ID: NCT00232089

Last Updated: 2016-11-18

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

1296 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Study Completion Date

2006-06-30

Brief Summary

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This study is being done to evaluate the safety, tolerability and satisfactory relief of dyspepsia symptoms in females excluding those with predominant stomach pain. Tegaserod will be evaluated at 6mg twice daily and placebo.

Detailed Description

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Conditions

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Dyspepsia

Keywords

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Dyspepsia, gastrointestinal, tegaserod

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Tegaserod

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Female patients, 18 years and older
* Self-reported presence of persistent or recurrent adverse digestive symptoms consistent with dyspepsia; for at least 12 weeks, not necessarily consecutive, during the previous 12 months.

Exclusion Criteria

* Abnormal esophago-gastro-duodenoscopy (EGD) endoscopy findings such as any esophageal mucosal break, gastric erosions, gastric ulcers and/or duodenal ulcers/erosions on an EDG exam performed with 12 weeks prior to baseline.
* Current or history of erosive esophagitis confirmed by EGD
* Heartburn occurring 3 or more days a week.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Principal Investigators

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Novartis

Role: STUDY_CHAIR

East Hanover NJ

Locations

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Novartis

East Hanover, New Jersey, United States

Site Status

Countries

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United States

References

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Vakil N, Laine L, Talley NJ, Zakko SF, Tack J, Chey WD, Kralstein J, Earnest DL, Ligozio G, Cohard-Radice M. Tegaserod treatment for dysmotility-like functional dyspepsia: results of two randomized, controlled trials. Am J Gastroenterol. 2008 Aug;103(8):1906-19. doi: 10.1111/j.1572-0241.2008.01953.x. Epub 2008 Jul 4.

Reference Type RESULT
PMID: 18616658 (View on PubMed)

Other Identifiers

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CHTF919D2302

Identifier Type: -

Identifier Source: org_study_id