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

This study has been withdrawn prior to recruitment.

First Received: January 13, 2006 Last Updated: September 7, 2006 History of Changes

Sponsor:	Novartis
Collaborator:	Mayo Clinic
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00277550

Purpose

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

Condition	Intervention	Phase
Constipation and Dyspepsia	Drug: Tegaserod and Placebo	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Pharmacodynamics Study
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Constipation Indigestion

Drug Information available for: Tegaserod Tegaserod maleate

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:

Eligibility

Ages Eligible for Study:	18 Years to 64 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00277550

Sponsors and Collaborators

Novartis

Mayo Clinic

Investigators

Principal Investigator:	Nicholas Talley, MD	Mayo Clinic
Principal Investigator:	Michael Crowell, PhD	Mayo Clinic Scottsdale

More Information

No publications provided

Study ID Numbers:	CHTF919EUS42
Study First Received:	January 13, 2006
Last Updated:	September 7, 2006
ClinicalTrials.gov Identifier:	NCT00277550 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Constipation, Tegaserod, Dyspepsia

Additional relevant MeSH terms:

Serotonin Agonists
Signs and Symptoms
Neurotransmitter Agents
Serotonin Agents
Molecular Mechanisms of Pharmacological Action
Signs and Symptoms, Digestive

Physiological Effects of Drugs
Constipation
Dyspepsia
Pharmacologic Actions
Tegaserod

ClinicalTrials.gov processed this record on November 30, 2009