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Effects of Oxybutynin Topical Gel on Gastric Emptying

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00926926
First Posted: June 24, 2009
Last Update Posted: October 8, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Watson Pharmaceuticals
  Purpose
This study explores the effect of oxybutynin topical gel on gastric emptying

Condition Intervention Phase
Healthy Drug: Oxybutynin Chloride Gel Drug: Placebo Gel Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Watson Pharmaceuticals:

Primary Outcome Measures:
  • 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 ]

Enrollment: 23
Study Start Date: June 2009
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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.
  Contacts and Locations
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
  More Information

Responsible Party: Watson Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00926926     History of Changes
Other Study ID Numbers: OTG0901
First Submitted: June 22, 2009
First Posted: June 24, 2009
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


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