NCT00926926

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Jun 2009

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

June 22, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 24, 2009

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

October 8, 2012

Status Verified

October 1, 2012

Enrollment Period

1 month

First QC Date

June 22, 2009

Last Update Submit

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:

  • 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.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Saint Charles, Missouri, United States

Location

Study Officials

  • Scott Olsen, MPH

    Watson Laboratories

    STUDY DIRECTOR

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 1, 2009

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

October 8, 2012

Record last verified: 2012-10

Locations

US(1)