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

Phase 2

Completed

• Conditions: Health

• Registration Number: NCT00332137
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

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.

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2006-05-30
• Study First Submitted QC: 2006-05-31
• Study First Posted: 2006-06-01
• Primary Completion: 2007-08
• Study Completion: 2007-08
• Status Verified: 2011-03
• Last Update Submitted: 2011-03-21
• Last Update Posted: 2011-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Colonic transit (as measured by GC24)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States