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Effect of Tegaserod on Orocecal Transit in Elderly Chronic Constipation Patients

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ClinicalTrials.gov Identifier: NCT00348634
Recruitment Status : Terminated (Terminated early due to regulatory action suspending tegaserod use in 2007)
First Posted : July 4, 2006
Last Update Posted : March 4, 2016
Sponsor:
Collaborators:
Temple University
University of Michigan
Information provided by (Responsible Party):
Novartis

July 3, 2006
July 4, 2006
March 4, 2016
July 2006
April 2007   (Final data collection date for primary outcome measure)
Orocecal transit: Time of radioactive marker to reach the cecum using scintigraphy
Same as current
Complete list of historical versions of study NCT00348634 on ClinicalTrials.gov Archive Site
Whole gut transit and stomach emptying: Following 2 weeks of treatment, the rate of transit of food through the colon and stomach will be measured using scintigraphy
Same as current
Not Provided
Not Provided
 
Effect of Tegaserod on Orocecal Transit in Elderly Chronic Constipation Patients
The Effects of Tegaserod on Orocecal Transit in Elderly Patients With Chronic Constipation
This study will evaluate the effects of tegaserod on orocecal and colonic transit in patients over 65 years with chronic constipation.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Chronic Constipation
Drug: Tegaserod
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
60
Same as current
April 2007
April 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male & Females aged 65 and older
  • Patients must meet the criteria for chronic idiopathic constipation for at least 12 weeks
  • Patients must have had a colonoscopy within the past 5 years
  • Patients must pass a balloon expulsion test at screening
  • Patients must be able to comply and understand the use of a diary

Exclusion Criteria:

  • Patients with a clinically significant medical condition that would interfere with the patient completing the trial
  • Patients with loose stools at least once per week
  • Patients with IBS
  • Known allergies to the same class of drug and/or allergies to eggs
  • Patients who require the use of manual maneuvers to have a bowel movement

Other protocol-defined inclusion/exclusion criteria may apply.

Sexes Eligible for Study: All
65 Years and older   (Older Adult)
Not Provided
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00348634
CHTF919EUS51
Not Provided
Not Provided
Not Provided
Novartis
Novartis
  • Temple University
  • University of Michigan
Study Chair: Henry Parkman, MD Temple
Study Chair: William Chey, MD University of Michigan
Novartis
March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP