Urinary IncontinencePhase 2NCT00475696
Urge Incontinence Bladder Overactivity Study
A Phase 2 study testing Duloxetine in people with Urinary Incontinence, run by Eli Lilly and Company at 3 sites in 3 countries.
Trial summary
Examine the efficacy and safety of duloxetine in subjects with symptoms of bladder overactivity due to pure detrusor instability or sensory urgency. Subjects in study will be permitted to escalate or de-escalate between 80 mg/day and 120 mg/day in consultation with the investigator and based on their adverse events. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- Duloxetine
- How many people
- 300 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Nov 2002to Mar 2005
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Are female outpatients.
- Are at least 18 years of age.
- Are ambulatory and able to use a toilet independently and without difficulty.
- Have no language or cognitive barriers, agree to comply with the requirements of the protocol, and sign a written informed consent document prior to entry into the study.
- Are women of non-childbearing potential by reason of hysterectomy or natural menopause, or are women of childbearing potential agreeing to use a medically accepted means of contraception (for example, intrauterine device [IUD], oral or injectable contraceptives, implant, barrier device, sterilization, abstinence, or sex with a vasectomized male partner) for the duration of the study. Women using oral contraceptives or hormone replacement therapy must have a stable dose and regimen for 3 months prior to the study.
- Have post-void residual (PVR) volume 100 mL within 15 minutes of a spontaneous void.
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- Patients must have predominant symptoms of bladder overactivity defined as meeting both of the following criteria:
- bothersome urinary urgency (the sensation of the urgent need to void for fear of leakage) for a minimum of 3 consecutive months prior to study entry, or urge urinary incontinence (UUI; the involuntary loss of urine preceded by urgency) for a minimum of 3 consecutive months prior to study entry
- abnormal frequency of micturition (an average voiding interval of 2 hours or less [2] during waking hours) as confirmed by at least two days of recording on the screening dairy collected at Visit 1.
- Have UDS established DI or sensory urgency (determined at Visit 2).
- Have responded appropriately to all screening questions prior to Visit 1.
Who cannot join
- Use any medication other than duloxetine for urinary incontinence within 1 day prior to starting study medication or at any time during the study.
- Use monoamine oxidase inhibitors (MAOIs) or other excluded medications within 14 days prior to starting study medication or at any time during the study.
- Have any of the following:
- A significant arrhythmia despite antiarrhythmic medication, uncontrolled angina, or a significant abnormality on ECG within 6 months prior to study entry that, in the opinion of the investigator, requires investigation or intervention.
- Any active cardiac ischemic condition, including myocardial infarction within 6 months prior to study entry
- Uncontrolled or poorly controlled hypertension
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- Active seizure disorder
- Unstable diabetes mellitus
- Spinal cord lesions, multiple sclerosis, or other neurological abnormalities that affect the lower urinary tract
- History of severe allergies requiring emergency medical treatment or multiple adverse drug reactions
- History of chronic lung disease associated with four (4) or more acute exacerbations per year resulting in severe coughing
- Active or chronic hepatitis A, B, or C.
- Are pregnant, have been pregnant in the previous 6 months, or have not resumed normal menstruation for 3 months prior to study entry due to breastfeeding.
- Are breastfeeding.
- Have received treatment within the last 30 days with a drug other than duloxetine that has not received regulatory approval in any country for any indication at the time of study entry.
- Have any condition, limitation, disease, or abnormal laboratory value that could, in the judgment of the investigator, preclude evaluation of response to duloxetine.
- Are directly affiliated with the conduct of this study, or are immediate family of someone directly affiliated with the conduct of this study (that is, Lilly employees, investigators, site personnel, or their immediate families). Immediate family is defined as a spouse, parent, child or sibling, whether biological or legally adopted.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
United States1 site
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Indianapolis, Indiana
Australia1 site
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Townsville, Queensland
Canada1 site
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
North York, Ontario
About this study
Official title: Long-Term Monitoring of Safety in Subjects Treated With Duloxetine for Bladder Overactivity
Examine the efficacy and safety of duloxetine in subjects with symptoms of bladder overactivity due to pure detrusor instability or sensory urgency. Subjects in study will be permitted to escalate or de-escalate between 80 mg/day and 120 mg/day in consultation with the investigator and based on their adverse events.
- Conditions
- Urinary Incontinence
- Being tested
- Duloxetine
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DuloxetineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To monitor the safety of duloxetine 80 mg/day-120 mg/day in women with bladder overactivity due to pure detrusor instability or sensory urgency.
Secondary outcomes (1)
To assess the subject's self-perceived improvement since starting study medication as measured by change from baseline on the following validated 7-point scale, Patient's Global Impressions of Improvement scale (PGI-I).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2007 (estimated)
- Study startNov 2002
- Study completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- 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
- 300 participants
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00475696
- Sponsor's protocol ID
- 6984
- Other IDs
- F1J-MC-SBBX
- Status last verified
- May 2007
- First submitted
- 16 May 2007
- Last updated
- 21 May 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Monitoring of Safety in Subjects Treated With Duloxetine for Bladder Overactivity
- ClinicalTrials.gov ID
- NCT00475696
- Acronym / sponsor ID
- 6984
- Conditions
- Urinary Incontinence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Nov 2002
- Study completion
- Mar 2005 (actual)
- First posted
- 21 May 2007 (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.
Examine the efficacy and safety of duloxetine in subjects with symptoms of bladder overactivity due to pure detrusor instability or sensory urgency. Subjects in study will be permitted to escalate or de-escalate between 80 mg/day and 120 mg/day in consultation with the investigator and based on their adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Are female outpatients.
- Are at least 18 years of age.
- Are ambulatory and able to use a toilet independently and without difficulty.
- Have no language or cognitive barriers, agree to comply with the requirements of the protocol, and sign a written informed consent document prior to entry into the study.
- Are women of non-childbearing potential by reason of hysterectomy or natural menopause, or are women of childbearing potential agreeing to use a medically accepted means of contraception (for example, intrauterine device [IUD], oral or injectable contraceptives, implant, barrier device, sterilization, abstinence, or sex with a vasectomized male partner) for the duration of the study. Women using oral contraceptives or hormone replacement therapy must have a stable dose and regimen for 3 months prior to the study.
Key exclusion criteria (17 listed)
- Use any medication other than duloxetine for urinary incontinence within 1 day prior to starting study medication or at any time during the study.
- Use monoamine oxidase inhibitors (MAOIs) or other excluded medications within 14 days prior to starting study medication or at any time during the study.
- Have any of the following:
- Are pregnant, have been pregnant in the previous 6 months, or have not resumed normal menstruation for 3 months prior to study entry due to breastfeeding.
- Are breastfeeding.
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 |
|---|---|---|
| Duloxetine | Drug | – |
Primary outcome
To monitor the safety of duloxetine 80 mg/day-120 mg/day in women with bladder overactivity due to pure detrusor instability or sensory urgency.
1 secondary outcome
To assess the subject's self-perceived improvement since starting study medication as measured by change from baseline on the following validated 7-point scale, Patient's Global Impressions of Improvement scale (PGI-I).
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 21 May 2007.
- Lilly Clinical Trial RegistryLink provided by the sponsor.
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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.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Duloxetine in people with Urinary Incontinence, run by Eli Lilly and Company at 3 sites in 3 countries.
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 11 inclusion and 17 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 21 May 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Australia, Canada. 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?
To monitor the safety of duloxetine 80 mg/day-120 mg/day in women with bladder overactivity due to pure detrusor instability or sensory urgency.. 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 21 May 2007.