Effects of Oxybutynin Topical Gel on Gastric Emptying

This study has been completed.
Information provided by (Responsible Party):
Watson Pharmaceuticals
ClinicalTrials.gov Identifier:
First received: June 22, 2009
Last updated: October 5, 2012
Last verified: October 2012
This study explores the effect of oxybutynin topical gel on gastric emptying

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

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


Ages Eligible for Study:   18 Years and older
Genders 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00926926

United States, Missouri
St. Charles, Missouri, United States
Sponsors and Collaborators
Watson Pharmaceuticals
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 
Study First Received: June 22, 2009
Last Updated: October 5, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Watson Pharmaceuticals:
Healthy volunteer

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

ClinicalTrials.gov processed this record on May 26, 2016