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

Information source: Mayo Clinic
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Health

Intervention: Tolterodine (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Mayo Clinic


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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: Colonic transit (as measured by GC24)

Secondary outcome:

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

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.


Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.


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.

Locations and Contacts

Mayo Clinic, Rochester, Minnesota 55905, United States
Additional Information

Starting date: September 2005
Last updated: March 21, 2011

Page last updated: August 23, 2015

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