Effects of Tolterodine, a Non-Specific Muscarinic Antagonist, on Gastrointestinal Transit in Healthy Subjects
NCT00332137
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| Descriptive Information | |||
|---|---|---|---|
| Brief Title ICMJE | Effects of Tolterodine, a Non-Specific Muscarinic Antagonist, on Gastrointestinal Transit in Healthy Subjects | ||
| Official Title ICMJE | Effects of Tolterodine, a Non-Specific Muscarinic Antagonist, on Gastrointestinal Transit in Healthy Subjects | ||
| 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 Type ICMJE | Interventional | ||
| Study Phase ICMJE | Phase 2 | ||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Treatment | ||
| Condition ICMJE | Health | ||
| Intervention ICMJE | Drug: Tolterodine | ||
| Study Arms ICMJE | Not Provided | ||
| Publications * | Not Provided | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||
| Recruitment Information | |||
| Recruitment Status ICMJE | Completed | ||
| Enrollment ICMJE | 36 | ||
| Original Enrollment ICMJE | Same as current | ||
| Actual Study Completion Date ICMJE | August 2007 | ||
| Actual Primary Completion Date | August 2007 (Final data collection date for primary outcome measure) | ||
| Eligibility Criteria ICMJE | 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. | ||
| Sex/Gender ICMJE |
| ||
| Ages ICMJE | 18 Years to 70 Years (Adult, Older Adult) | ||
| Accepts Healthy Volunteers ICMJE | Yes | ||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
| Listed Location Countries ICMJE | United States | ||
| Removed Location Countries | |||
| Administrative Information | |||
| NCT Number ICMJE | NCT00332137 | ||
| Other Study ID Numbers ICMJE | 1696-05 | ||
| Has Data Monitoring Committee | Not Provided | ||
| U.S. FDA-regulated Product | Not Provided | ||
| IPD Sharing Statement ICMJE | Not Provided | ||
| Responsible Party | Not Provided | ||
| Study Sponsor ICMJE | Mayo Clinic | ||
| Collaborators ICMJE | Pfizer | ||
| Investigators ICMJE | Not Provided | ||
| PRS Account | Mayo Clinic | ||
| Verification Date | March 2011 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||