Urologic Diseases Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled Study to Explore the Efficacy, Safety, and Tolerability of JNJ-42160443 in Subjects With Interstitial Cystitis/ Painful Bladder Syndrome
Verified date | October 2021 |
Source | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to evaluate the analgesic efficacy, safety, and tolerability of JNJ-42160443 compared to placebo in patients with moderate to severe, chronic bladder pain from interstitial cystitis and/or painful bladder syndrome.
Status | Terminated |
Enrollment | 31 |
Est. completion date | June 24, 2011 |
Est. primary completion date | June 24, 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - Chronic pelvic pain (>6 months) perceived to be related to the urinary bladder and accompanied by urinary symptoms such as frequent urination during the day and/or night, and/or urgency to void - Total score of 8 or greater on the O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) - The mean of the average pain intensity scores at screening phase >=5 (on a scale of 0 to 10) - Medically stable Exclusion Criteria: - Urinary culture is positive for a urinary tract infection; Recent invasive therapy to the bladder - History or current conditions indicating that the bladder pain can be caused by diagnoses other than IC/PBS (eg, pain caused by a confirmed or suspected neoplasm) - History of malignancy within the past 2 years, with the exception of basal cell carcinoma that has been successfully treated - Women who are pregnant or breast-feeding - A body mass index (BMI) of >39 kg/m2 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The change in the average pain intensity score. | The change from baseline to the end of the double-blind phase in the mean average pain intensity score (12 weeks). | ||
Secondary | Evaluation of Global Response Assessment (GRA) | 12 weeks | ||
Secondary | Changes from baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) | 12 weeks | ||
Secondary | Change in Pelvic Pain and Urgency/Frequency Questionnaire (PUF) | 12 weeks | ||
Secondary | Changes from baseline to end of the double-blind phase in subscale scores of the Short Form (SF)-12 Health Survey | 12 weeks | ||
Secondary | Antibody against JNJ-42160443 | 34 weeks |
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