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.
  Contacts and Locations
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

No publications provided

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
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Autonomic Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents

ClinicalTrials.gov processed this record on April 15, 2014