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”

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

Study Type: Interventional

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

Intervention(s) in this Clinical Trial

• Drug: Tegaserod and Placebo

Primary Measures

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

Secondary Measures

• 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

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 64 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Novartis

Overall Clinical Trial Officials and Contacts

Nicholas Talley, MD Principal Investigator Mayo Clinic  

Information obtained from ClinicalTrials.gov on October 06, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00277550

Study ID Number: CHTF919EUS42

ClinicalTrials.gov Identifier: NCT00277550

Health Authority: United States: Food and Drug Administration