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Effects of Oxybutynin Topical Gel on Gastric Emptying

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Watson Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00926926
First received: June 22, 2009
Last updated: October 5, 2012
Last verified: October 2012
History of Changes
  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
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:

U.S. FDA Resources

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

  Eligibility

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

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:
Acetaminophen
Oxybutynin
Mandelic Acids
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
 Therapeutic Uses
Parasympatholytics
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 May 16, 2013