NCT00926926

CompletedPhase 1

Effects of Oxybutynin Topical Gel on Gastric Emptying

Watson Pharmaceuticals Source

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Other study identifiers

Sponsor study identifier

OTG0901

Study Type

interventional

Actual enrollment (reported)

23

Locations

1 country

Sites

1

Timeline

Study Start

June 2009

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

July 2009

Actual (reported)

Study Completion

July 2009

Actual (reported)

Brief Summary

This study explores the effect of oxybutynin topical gel on gastric emptying

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 23 participants
Study completion date: July 2009
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
June 2009
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
June 22, 2009
Actual (reported)
First Posted
June 24, 2009
Actual (reported)
Primary Completion
July 2009
Actual (reported)
Study Completion
July 2009
Actual (reported)

Last Updated: October 8, 2012
Status Verified: October 2012
Last Update Submitted: October 5, 2012

Conditions

Healthy

Keywords

Healthy volunteer

Outcome Measures

Primary Outcomes (1)

The effect of oxybutynin chloride topical gel administration on gastric emptying will be assessed by comparing the single dose relative bioavailability of acetaminophen
After 7 days of treatment

Study Arms (2)

Active OTG

EXPERIMENTAL

Drug: Oxybutynin Chloride Gel

Placebo

PLACEBO COMPARATOR

Drug: Placebo Gel

Interventions

Oxybutynin Chloride GelDrug

Once daily for 7 days, followed by single dose of acetaminophen

Active OTG

Placebo GelDrug

Once daily for 7 days, followed by single dose of acetaminophen

Placebo

Eligibility Criteria

Age18 Years+

Sexfemale

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Adult, healthy, post-menopausal females

You may not qualify if:

Sponsors & Collaborators

Watson Pharmaceuticals
Industrylead

Study Sites (1)

Saint Charles, Missouri, United States

Study Officials

Scott Olsen, MPH
Watson Laboratories
STUDY DIRECTOR

Enrollment

23 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: BASIC SCIENCE
Intervention Model: CROSSOVER
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

June 22, 2009

First Posted

June 24, 2009

Study Start

June 2009

Date type not reported

This date has not been verified as actual or estimated.

NCT00650481

Fasting Study of Oxybutynin Chloride Extended-release Tablets 5 mg and Ditropan XL® Tablets 5 mg

Phase 1Completed

NCT00649727

Fed Study of Oxybutynin Chloride Extended-release Tablets 10 mg and Ditropan XL® Tablets 10 mg

Phase 1Completed

NCT00752141

Cognitive Effects of Oral Oxybutynin and Oxybutynin Chloride Topical Gel in Older Volunteers

Phase 1Completed

NCT00603772

Clinical Evaluation of the Photoallergy Potential of Atralin Gel

Phase 1Completed

NCT00604032

Study to Determine the Phototoxity of Atralin (Tretinoin) Gel, 0.05%

Phase 1Completed

NCT00905762

Concentration of Besifloxacin, Gatifloxacin, and Moxifloxacin in Human Conjunctiva After Topical Instillation

Phase 1Completed

Patients for whom OTG or acetaminophen is contraindicated.

Abnormality of the GI tract.

Taking drugs that affect gastric motility.

Contact the study team to confirm eligibility.

Primary Completion

July 2009

Actual (reported)

Study Completion

July 2009

Actual (reported)

Last Updated

October 8, 2012

Record last verified: 2012-10

Source record

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Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00926926
Data provider: ClinicalTrials.gov
Source updated: 2012-10-08
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:36:46 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Active OTG

Placebo

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations