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Effects of Tolterodine, a Non-Specific Muscarinic Antagonist, on Gastrointestinal Transit in Healthy Subjects

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00332137
First received: May 30, 2006
Last updated: March 21, 2011
Last verified: March 2011
History of Changes
  Purpose

The muscarinic antagonist tolterodine is widely used treat urinary urge incontinence. Though acteylcholine is the primary excitatory neurotransmitter in the gastrointestinal tract, the phase III trials suggest that tolterodine infrequently causes constipation. Therefore, the objectives of this study are to assess if tolterodine affects the speed at which food travels through the stomach, intestines and colon (i.e., gastrointestinal and colonic transit) in healthy subjects.


Condition Intervention Phase
Health
 Drug: Tolterodine
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Effects of Tolterodine, a Non-Specific Muscarinic Antagonist, on Gastrointestinal Transit in Healthy Subjects

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Colonic transit (as measured by GC24)

Secondary Outcome Measures:
  • Colonic transit (GC48)
  • Ascending colon emptying t1/2
  • Colonic filling at 6 hours, i.e. a surrogate marker of small bowel transit time
  • Gastric emptying time (1, 2, 4 hours, thalf)
  • Average number of stools per day before and during treatment

Estimated Enrollment: 36
Study Start Date: September 2005
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Detailed Description:

The specific aims of this study are to test the hypotheses that the non-specific muscarinic antagonist tolterodine will not:- i) delay colonic transit and the proximal colonic emptying rate; ii) delay gastric emptying; nor iii) delay small intestinal transit compared to placebo in healthy subjects.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Age 18-70 years old. Absence of gastrointestinal symptoms as characterized by bowel symptoms questionnaire and absence of significant anxiety or depression characterized by a hospital anxiety and depression questionnaire.

Able to understand and willing to sign informed consent. Females who are nonpregnant, nonlactating, and willing to use a clinically approved methods of contraception two weeks prior to Day 0 until 1 week after the last dose of study medication.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00332137

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Pfizer
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00332137     History of Changes
Other Study ID Numbers: 1696-05
Study First Received: May 30, 2006
Last Updated: March 21, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Muscarinic Antagonists
Tolterodine
Cholinergic Antagonists
Cholinergic Agents
 Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013