|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT00277550 |
|
Date of registration:
|
13/01/2006 |
|
Primary sponsor: |
|
|
Public title:
|
The Effects of Tegaserod Vs. Placebo on Whole Gut Transit Time in Patients With Chronic Constipation and Dyspepsia
|
|
Scientific 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 |
|
Date of first enrolment:
|
March 2006 |
|
Target sample size:
|
64 |
|
Recruitment status: |
Withdrawn |
|
URL:
|
http://clinicaltrials.gov/show/NCT00277550 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Michael Crowell, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Mayo Clinic |
|
|
Name:
|
Nicholas Talley, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Mayo Clinic |
| |
|
Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
64 Years
Gender:
Female
|
|
Health Condition(s) or Problem(s) studied
|
|
Constipation and Dyspepsia
|
|
Intervention(s)
|
|
Drug: Tegaserod and Placebo
|
|
Primary Outcome(s)
|
|
To determine the effect of one week of tegaserod on the passage of content through the gut by radiological procedures.
|
|
Secondary Outcome(s)
|
|
To evaluate global well-being & upper and lower GI symptoms in daily assessment of bowel habits and weekly global and individual symptom assessments
|
|
To evaluate the PD effects of tegaserod on upper & lower GI transit
|
|
Secondary ID(s)
|
|
CHTF919EUS42
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|