Urinary Incontinence, UrgePhase 2FP1097-002NCT00749632
A Study of Oxybutynin for the Treatment of Urge Urinary Incontinence
A Phase 2 study testing oxybutynin in people with Urinary Incontinence, Urge, run by FemmePharma Global Healthcare, Inc. at 2 sites in United States.
Trial summary
The purpose of this study is to determine the safety of three doses of oxybutynin for the treatment of urge urinary incontinence. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Urinary Incontinence, Urge
- What is being tested?
- oxybutynin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2007to Oct 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females 18 to 75 years of age
- Has reported symptoms of urge urinary incontinence/overactive bladder
Who cannot join
- Is pregnant or lactating
- Has had lower urinary tract surgery within 6 months prior to Screening
- Has a history of urinary retention
Trial locations and contacts
2 sites in 1 country.
United States2 sites
SNBL Clinical Pharmacology Center
Baltimore, Maryland, 21201
Advanced Biomedical Research
Hackensack, New Jersey, 07601
About this study
Official title: An Open-Label, Dose Escalating Study to Evaluate the Safety of Intravaginal Oxybutynin in Subjects With Urge Urinary Incontinence
The purpose of this study is to determine the safety of three doses of oxybutynin for the treatment of urge urinary incontinence.
- Conditions
- Urinary Incontinence, Urge
- Being tested
- oxybutynin
- Keywords
- urinary incontinence, urge, urinary urge incontinence, urge incontinence, over active bladder
- Medical subject headings
- Urinary Incontinence, Urge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxybutyninDrug
low dose oxybutynin administered daily
oxybutyninDrug
middle dose oxybutynin administered daily
oxybutyninDrug
high dose oxybutynin administered daily
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: oxybutynin |
| 2 | Active comparator | Not described Receives: Drug: oxybutynin |
| 3 | Active comparator | Not described Receives: Drug: oxybutynin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of micturations and incontinence episodes.
Measured: Two weeks pretreatment and three weeks on treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2008 (estimated)
- Study startJul 2007
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Incontinence, UrgeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- FemmePharma Global Healthcare, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Peter K. Mays, Ph.D., Study director, FemmePharma Global Healthcare, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00749632
- Sponsor's protocol ID
- FP1097-002
- Acronym
- FP1097-002
- Status last verified
- Oct 2009
- First submitted
- 5 Sep 2008
- Last updated
- 15 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Dose Escalating Study to Evaluate the Safety of Intravaginal Oxybutynin in Subjects With Urge Urinary Incontinence
- ClinicalTrials.gov ID
- NCT00749632
- Acronym / sponsor ID
- FP1097-002 / FP1097-002
- Conditions
- Urinary Incontinence, Urge
- Keywords
- urinary incontinence, urge, urinary urge incontinence, urge incontinence, over active bladder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- FemmePharma Global Healthcare, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 9 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the safety of three doses of oxybutynin for the treatment of urge urinary incontinence.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: oxybutynin |
| 2 | Active comparator | Drug: oxybutynin |
| 3 | Active comparator | Drug: oxybutynin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Females 18 to 75 years of age
- Has reported symptoms of urge urinary incontinence/overactive bladder
Key exclusion criteria (3 listed)
- Is pregnant or lactating
- Has had lower urinary tract surgery within 6 months prior to Screening
- Has a history of urinary retention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oxybutyninlow dose oxybutynin administered daily | Drug | 1 |
| oxybutyninmiddle dose oxybutynin administered daily | Drug | 2 |
| oxybutyninhigh dose oxybutynin administered daily | Drug | 3 |
Primary outcome
Number of micturations and incontinence episodes.
Time frame: Two weeks pretreatment and three weeks on treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter K. Mays, Ph.D. study director
FemmePharma Global Healthcare, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing oxybutynin in people with Urinary Incontinence, Urge, run by FemmePharma Global Healthcare, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of micturations and incontinence episodes. (time frame: Two weeks pretreatment and three weeks on treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2009.