NCT01060254

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cystitis, Interstitial
• Urologic Diseases
• Urinary Bladder Diseases
• Cystitis

Interventions

Type	Name	Description
DRUG	Placebo	Form=solution for injection, route=Subcutaneous injection. One injection of matching placebo every 28 days for up to 12 wks
DRUG	JNJ-42160443	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

Timeline

• Start date: 2010-04-06
• Primary completion: 2011-06-24
• Completion: 2011-06-24
• First posted: 2010-02-02
• Last updated: 2021-10-18

Locations

25 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study