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

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Novartis
• Collaborator: Mayo Clinic
• Treatments: Tegaserod

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