The Effects of Tegaserod Vs. Placebo on Whole Gut Transit Time in Patients With Chronic Constipation and Dyspepsia
Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Constipation and Dyspepsia
Intervention: Tegaserod and Placebo (Drug)
Phase: Phase 4
Status: Withdrawn
Sponsored by: Novartis Official(s) and/or principal investigator(s): Nicholas Talley, MD, Principal Investigator, Affiliation: Mayo Clinic Michael Crowell, PhD, Principal Investigator, Affiliation: Mayo Clinic
Summary
To demonstrate the effects of tegaserod on gastrointestinal scintigraphic orocecal transit
in female patients with CC and upper GI symptoms of dyspepsia
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: To determine the effect of one week of tegaserod on the passage of content through the gut by radiological procedures.
Secondary outcome: To evaluate the PD effects of tegaserod on upper & lower GI transitTo evaluate global well-being & upper and lower GI symptoms in daily assessment of bowel habits and weekly global and individual symptom assessments
Eligibility
Minimum age: 18 Years.
Maximum age: 64 Years.
Gender(s): Female.
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
Locations and Contacts
Additional Information
Last updated: September 7, 2006
|