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

Phase 4

Withdrawn

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

Recruitment & Eligibility

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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

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