Urge Incontinence Bladder Overactivity Study

NCT00475696 | Completed Phase 2

• 2 other identifiers: 6984F1J-MC-SBBX
• Study Type: interventional
• Target: 300
• Locations: 3 countries
• Sites: 3

Brief 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.

Conditions

Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

• 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).

Interventions

Duloxetine DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (3)

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, United States

Location

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, Australia

Location

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, Canada

Location

Related Links

• Lilly Clinical Trial Registry

MeSH Terms

Conditions

Urinary Incontinence

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• 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)

  Eli Lilly and Company

  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: May 16, 2007
• First Posted: May 21, 2007
• Study Start: November 1, 2002
• Study Completion: March 1, 2005
• Last Updated: May 21, 2007

Record last verified: 2007-05

Locations

CA (1); AU (1); US (1)