Status:
WITHDRAWN
The Effects of Tegaserod vs. Placebo on Whole Gut Transit Time in Patients With Chronic Constipation and Dyspepsia
Lead Sponsor:
Novartis
Collaborating Sponsors:
Mayo Clinic
Conditions:
Constipation and Dyspepsia
Eligibility:
FEMALE
18-64 years
Phase:
PHASE4
Brief Summary
To demonstrate the effects of tegaserod on gastrointestinal scintigraphic orocecal transit in female patients with CC and upper GI symptoms of dyspepsia
Eligibility Criteria
Inclusion
- 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:
- Less than 3 bowel movements per week
- Hard or lumpy stools
- Straining during bowel movements
- 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
- 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
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00277550
Last Update
March 4 2016
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