Effects of Oxybutynin Topical Gel on Gastric Emptying | NCT00926926

Studies
Effects of Oxybutynin Topical Gel on Gastric Emptying

NCT00926926

Sponsor

Watson Pharmaceuticals

Status

Completed

Last Update Posted

Oct 8, 2012Estimated

Enrollment

23Actual

Phase

Phase 1

Conditions

Healthy

Interventions

Oxybutynin Chloride Gel
Placebo Gel

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2009

Primary Completion Date

Jul 2009Actual

Completion Date

Jul 2009Actual

First Submitted Date

Jun 22, 2009

First Submission Date that Met QC Criteria

Jun 23, 2009

First Posted Date

Jun 24, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 5, 2012

Last Update Posted Date

Oct 8, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

23Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Active OTG	Experimental		Drug: Oxybutynin Chloride Gel
Placebo	Placebo Comparator		Drug: Placebo Gel

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Oxybutynin Chloride Gel	Drug	Once daily for 7 days, followed by single dose of acetaminophen	Active OTG

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Scott Olsen, MPH	Watson Laboratories	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Saint Charles	Missouri		United States