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Effects of Oxybutynin Topical Gel on Gastric Emptying

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ClinicalTrials.gov Identifier: NCT00926926
Recruitment Status : Completed
First Posted : June 24, 2009
Last Update Posted : October 8, 2012
Sponsor:
Information provided by (Responsible Party):
Watson Pharmaceuticals

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 Type : Interventional  (Clinical Trial)
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 : June 2009
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



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 [ Time Frame: After 7 days of treatment ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00926926


Locations
United States, Missouri
St. Charles, Missouri, United States
Sponsors and Collaborators
Watson Pharmaceuticals
Investigators
Study Director: Scott Olsen, MPH Watson Laboratories

Responsible Party: Watson Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00926926     History of Changes
Other Study ID Numbers: OTG0901
First Posted: June 24, 2009    Key Record Dates
Last Update Posted: October 8, 2012
Last Verified: October 2012

Keywords provided by Watson Pharmaceuticals:
Healthy volunteer

Additional relevant MeSH terms:
Acetaminophen
Oxybutynin
Mandelic Acids
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Parasympatholytics
Autonomic Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Urological Agents
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents