Effects of Oxybutynin Topical Gel on Gastric Emptying

• Sponsor: Watson Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00926926
• Collaborator: (none)
• Enrollment: 23
• Location: 1
• Arms: 2
• Duration (Days): 30
• Patients Per Site Per Month: 23.3

Study Details

Study Description

Brief Summary

This study explores the effect of oxybutynin topical gel on gastric emptying

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Oxybutynin Chloride Gel; Drug: Placebo Gel	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 23 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: Effect of Oxybutynin Chloride Topical Gel on Gastric Emptying, Using the Acetaminophen Absorption Test
• Study Start Date: Jun 1, 2009
• Actual Primary Completion Date: Jul 1, 2009
• Actual Study Completion Date: Jul 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Active OTG	Drug: Oxybutynin Chloride Gel; Once daily for 7 days, followed by single dose of acetaminophen
Placebo Comparator: Placebo	Drug: Placebo Gel; Once daily for 7 days, followed by single dose of acetaminophen

Outcome Measures

Primary Outcome Measures

1. The effect of oxybutynin chloride topical gel administration on gastric emptying will be assessed by comparing the single dose relative bioavailability of acetaminophen [After 7 days of treatment]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Adult, healthy, post-menopausal females

Exclusion Criteria:

• Patients for whom OTG or acetaminophen is contraindicated.

• Abnormality of the GI tract.

• Taking drugs that affect gastric motility.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		St. Charles	Missouri	United States

Sponsors and Collaborators

• Watson Pharmaceuticals

Investigators

• Study Director: Scott Olsen, MPH, Watson Laboratories

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Watson Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT00926926
• Other Study ID Numbers: OTG0901
• First Posted: Jun 24, 2009
• Last Update Posted: Oct 8, 2012
• Last Verified: Oct 1, 2012

• Keywords provided by Watson Pharmaceuticals: Healthy volunteer
• Additional relevant MeSH terms: Oxybutynin

Study Results

No Results Posted as of Oct 8, 2012