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

TerminatedPhase 2NCT01060254

View the official record on ClinicalTrials.gov

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Brief summary (from the registry)

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.

Study details

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
Conditions: Cystitis, Interstitial
Urologic Diseases
Urinary Bladder Diseases
Cystitis
Interventions: Drug: Placebo
Drug: JNJ-42160443
Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Start date: 2010-04-06
Primary completion: 2011-06-24
Sex: All
Age range: from 18 Years to 80 Years
Results posted: No results posted in this snapshot
Countries: Canada, United States
Total sites listed: 25

Eligibility criteria

Show eligibility criteria (verbatim from the registry)

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

Canadian sites (5)

Facility	City	Province
	Barrie	Ontario
	Kingston	Ontario
	Kitchener	Ontario
	North York	Ontario
	Toronto	Ontario

Canadian sites for NCT01060254. 4 mapped locations with coordinates in the registry. Schematic plot, not to scale.

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01060254