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

Tracking Information

First Received Date ^ICMJE

January 13, 2006

Last Updated Date

September 7, 2006

Start Date ^ICMJE

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00277550 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Pharmacodynamics Study

Condition ^ICMJE

Constipation and Dyspepsia

Intervention ^ICMJE

Drug: Tegaserod and Placebo

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Withdrawn

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years to 64 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00277550

Responsible Party

Study ID Numbers ^ICMJE

CHTF919EUS42

Study Sponsor ^ICMJE

Novartis

Collaborators ^ICMJE

Mayo Clinic

Investigators ^ICMJE

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

Information Provided By

Novartis

Verification Date

September 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP