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

A Randomized, Double-blind, Placebo-controlled Evaluation of the Effects of Tegaserod (6 mg b.i.d) on Whole Gut Transit Time in Patients With Chronic Idiopathic Constipation and Dyspepsia

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00277550

Enrollment

Registered

2006-01-16

Start date

Unknown

Completion date

Unknown

Last updated

2016-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Constipation and Dyspepsia

Keywords

Constipation, Tegaserod, Dyspepsia

Brief summary

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

Interventions

DRUGTegaserod and Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 64 Years

Healthy volunteers

Yes

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 * Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
To determine the effect of one week of tegaserod on the passage of content through the gut by radiological procedures.	—

Secondary

Measure	Time frame
To evaluate the PD effects of tegaserod on upper & lower GI transit	—
To evaluate global well-being & upper and lower GI symptoms in daily assessment of bowel habits and weekly global and individual symptom assessments	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026