Effects of Tolterodine, a Non-Specific Muscarinic Antagonist, on Gastrointestinal Transit in Healthy Subjects
Information source: Mayo Clinic
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Health
Intervention: Tolterodine (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Mayo Clinic Official(s) and/or principal investigator(s):
Adil E. Bharucha, M.B.B.S., M.D., Principal Investigator, Affiliation: Mayo Clinic
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.
Clinical Details
Official title: Effects of Tolterodine, a Non-Specific Muscarinic Antagonist, on Gastrointestinal Transit in Healthy Subjects
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Pharmacokinetics/Dynamics Study
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 Stool consistency before and during treatment Serum anticholinergic activity measured by 3H-QNB assay
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
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
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.
Locations and Contacts
Mayo Clinic, Rochester, Minnesota 55905, United States
Additional Information
Starting date: September 2005
Ending date: April 2006
Last updated: May 31, 2006
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