NCT00749632

Brief Summary

The purpose of this study is to determine the safety of three doses of oxybutynin for the treatment of urge urinary incontinence.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2007

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 5, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 9, 2008

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

October 15, 2009

Status Verified

October 1, 2009

Enrollment Period

1.3 years

First QC Date

September 5, 2008

Last Update Submit

October 13, 2009

Conditions

Urinary Incontinence, Urge

Keywords

urinary incontinence, urgeurinary urge incontinenceurge incontinenceover active bladder

Outcome Measures

Primary Outcomes (1)

  • Number of micturations and incontinence episodes.

    Two weeks pretreatment and three weeks on treatment

Study Arms (3)

1

ACTIVE COMPARATOR
Drug: oxybutynin

2

ACTIVE COMPARATOR
Drug: oxybutynin

3

ACTIVE COMPARATOR
Drug: oxybutynin

Interventions

oxybutyninDRUG

low dose oxybutynin administered daily

1

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Females 18 to 75 years of age
  • Has reported symptoms of urge urinary incontinence/overactive bladder

You may not qualify if:

  • Is pregnant or lactating
  • Has had lower urinary tract surgery within 6 months prior to Screening
  • Has a history of urinary retention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

SNBL Clinical Pharmacology Center

Baltimore, Maryland, 21201, United States

Location

Advanced Biomedical Research

Hackensack, New Jersey, 07601, United States

Location

MeSH Terms

Conditions

Urinary Incontinence, Urge

Interventions

oxybutynin

Condition Hierarchy (Ancestors)

Urinary IncontinenceUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Peter K. Mays, Ph.D.

    FemmePharma Global Healthcare, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 5, 2008

First Posted

September 9, 2008

Study Start

July 1, 2007

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

October 15, 2009

Record last verified: 2009-10

Locations

US(2)