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

Phase 2

Terminated

• Conditions: Cystitis, Interstitial; Urologic Diseases; Urinary Bladder Diseases; Cystitis
• Interventions: Drug: Placebo; Drug: JNJ-42160443

• Registration Number: NCT01060254
• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2010-01-29
• Study First Submitted QC: 2010-01-29
• Study First Posted: 2010-02-02
• Study Start: 2010-04-06
• Primary Completion: 2011-06-24
• Study Completion: 2011-06-24
• Disposition First Submitted: 2012-04-26
• Disposition First Submitted QC: 2012-04-26
• Disposition First Posted: 2012-04-27
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-15
• Last Update Posted: 2021-10-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 31

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
JNJ-42160443	JNJ-42160443	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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