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

Condition(s) targeted: Constipation and Dyspepsia

Intervention: Tegaserod and Placebo (Drug)

Phase: Phase 4

Status: Withdrawn

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Nicholas Talley, MD, Principal Investigator, Affiliation: Mayo Clinic
Michael Crowell, PhD, Principal Investigator, Affiliation: Mayo Clinic Scottsdale

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

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

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

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

Secondary outcome:

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

Minimum age: 18 Years. Maximum age: 64 Years. Gender(s): Female.

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

Last updated: September 7, 2006