A Study to Evaluate the Pain Relieving Effects, Safety, and Tolerability of JNJ-42160443 for the Relief of Bladder Pain

Study Overview
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Brief Summary
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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.

Detailed Description
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This study is a randomized (study drug assigned by chance), double-blind (neither the physician nor the patient knows the name of the assigned drug) study to evaluate the analgesic efficacy, safety, and tolerability of JNJ-42160443 compared with placebo in patients with moderate to severe, chronic bladder pain from Interstitial cystitis (IC) and/or painful bladder syndrome (PBS). Interstitial cystitis (IC) and PBS are urological disorders characterized by symptoms of bladder pain, urinary urgency, urinary frequency, and the need to get up during the night in order to urinate. The study has 3 phases: a screening phase (up to 3 weeks), a double-blind treatment phase (12 weeks), and a post-treatment phase that ends 26 weeks after the last dose of study medication. The study duration will be approximately 36 to 46 weeks. A single dose of JNJ-42160443 (9 mg/ml) or matching placebo given as an injection under the skin once every 4 weeks for up to 12 weeks.

Official Title
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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

Conditions
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Cystitis, Interstitial, Urologic Diseases, Urinary Bladder Diseases, Cystitis

Intervention / Treatment
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* Drug: Placebo
* Drug: JNJ-42160443


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: JNJ-42160443<br> | Drug: JNJ-42160443<br>* Type=exact number, unit=mg, number= 9, form=solution for injection, route=Subcutaneous use. One injection of 9 mg of JNJ-42160443 every 28 days for up to 12 wks<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Form=solution for injection, route=Subcutaneous injection. One injection of matching placebo every 28 days for up to 12 wks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of Global Response Assessment (GRA) |  | 12 weeks | 
| Changes from baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) |  | 12 weeks | 
| Change in Pelvic Pain and Urgency/Frequency Questionnaire (PUF) |  | 12 weeks | 
| Changes from baseline to end of the double-blind phase in subscale scores of the Short Form (SF)-12 Health Survey |  | 12 weeks | 
| Antibody against JNJ-42160443 |  | 34 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Interstitial cystitis (IC) and/or painful bladder syndrome (PBS)-related pain, Moderate to severe chronic bladder pain, JNJ-42160443