The Effects of Tegaserod vs. Placebo on Whole Gut Transit Time in Patients With Chronic Constipation and Dyspepsia

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

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Brief Summary

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To demonstrate the effects of tegaserod on gastrointestinal scintigraphic orocecal transit in female patients with CC and upper GI symptoms of dyspepsia

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Detailed Description

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Conditions

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Constipation and Dyspepsia

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 and Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Females aged 18 to 64 years of age
* Patients must present with two or more of the following criteria for chronic constipation for at least 12 weeks prior to entering the study:

1. Less than 3 bowel movements per week
2. Hard or lumpy stools
3. Straining during bowel movements
4. Feeling of incomplete evacuation
* Patients must report overlapping symptoms consistent with dyspepsia, such as mid-upper abdominal discomfort characterized by early satiety, post-meal fullness and bloating

Exclusion Criteria

* Patients with a recent history of, or current frequency of diarrhea occuring more than once per month off of laxatives
* Clinically significant diagnosis of pelvic outlet obstruction or pelvic floor dyssenergia as determined by the study physicians
* Patients with constipation secondary to medication use as determined by the study physician
* Patients with clinically significant abnormal TSH levels at screening
* Patients that have heartburn or abdominal pain as their predominant GI symptom
* Evidence of cathartic colon or a history of laxative abuse

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes