Constipation and Dyspepsia Clinical Trial
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
| NCT number | NCT00277550 |
| Other study ID # | CHTF919EUS42 |
| Secondary ID | |
| Status | Withdrawn |
| Phase | Phase 4 |
| First received | January 13, 2006 |
| Last updated | March 2, 2016 |
| Verified date | March 2016 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
To demonstrate the effects of tegaserod on gastrointestinal scintigraphic orocecal transit in female patients with CC and upper GI symptoms of dyspepsia
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 18 Years to 64 Years |
| 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 |
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Novartis | Mayo Clinic |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | To determine the effect of one week of tegaserod on the passage of content through the gut by radiological procedures. | |||
| Secondary | To evaluate the PD effects of tegaserod on upper & lower GI transit | |||
| Secondary | To evaluate global well-being & upper and lower GI symptoms in daily assessment of bowel habits and weekly global and individual symptom assessments |