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

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 Overview

• Status: Terminated
• Conditions: Urologic Diseases; Urinary Bladder Diseases; Cystitis; Cystitis, Interstitial
• Intervention / Treatment: Drug: JNJ-42160443; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Barrie, Ontario, Canada
    • Kingston, Ontario, Canada
    • Kitchener, Ontario, Canada
    • North York, Ontario, Canada
    • Toronto, Ontario, Canada
• United States
  • Alabama
    • Birmingham, Alabama, United States
  • Arizona
    • Phoenix, Arizona, United States
  • California
    • Glendora, California, United States
    • San Diego, California, United States
  • Florida
    • Aventura, Florida, United States
  • Idaho
    • Eagle, Idaho, United States
  • Indiana
    • Jeffersonville, Indiana, United States
  • Kansas
    • Kansas City, Kansas, United States
    • Overland Park, Kansas, United States
  • Louisiana
    • Metairie, Louisiana, United States
    • New Orleans, Louisiana, United States
    • Shreveport, Louisiana, United States
  • Massachusetts
    • Brighton, Massachusetts, United States
  • Michigan
    • Royal Oak, Michigan, United States
  • New Jersey
    • Englewood, New Jersey, United States
  • New York
    • Poughkeepsie, New York, United States
  • North Carolina
    • Greensboro, North Carolina, United States
    • Winston-Salem, North Carolina, United States
  • Texas
    • Arlington, Texas, United States
    • Fair Oaks Ranch, Texas, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Drug: Placebo; Form=solution for injection, route=Subcutaneous injection. One injection of matching placebo every 28 days for up to 12 wks
EXPERIMENTAL: JNJ-42160443	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Publications and helpful links

General Publications

• Imamura M, Scott NW, Wallace SA, Ogah JA, Ford AA, Dubos YA, Brazzelli M. Interventions for treating people with symptoms of bladder pain syndrome: a network meta-analysis. Cochrane Database Syst Rev. 2020 Jul 30;7(7):CD013325. doi: 10.1002/14651858.CD013325.pub2.
• Wang H, Russell LJ, Kelly KM, Wang S, Thipphawong J. Fulranumab in patients with interstitial cystitis/bladder pain syndrome: observations from a randomized, double-blind, placebo-controlled study. BMC Urol. 2017 Jan 5;17(1):2. doi: 10.1186/s12894-016-0193-z.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 6, 2010
• Primary Completion (ACTUAL): June 24, 2011
• Study Completion (ACTUAL): June 24, 2011

Study Registration Dates

• First Submitted: January 29, 2010
• First Submitted That Met QC Criteria: January 29, 2010
• First Posted (ESTIMATE): February 2, 2010

Study Record Updates

• Last Update Posted (ACTUAL): October 18, 2021
• Last Update Submitted That Met QC Criteria: October 15, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: JNJ-42160443; Interstitial cystitis (IC) and/or painful bladder syndrome (PBS)-related pain; Moderate to severe chronic bladder pain
• Additional Relevant MeSH Terms: Cystitis; Cystitis, Interstitial; Urologic Diseases; Urinary Bladder Diseases
• Other Study ID Numbers: CR017017; 42160443PAI2005 (OTHER: Johnson & Johnson Pharmaceutical Research and Development, L.L.C.); 2009-009856-19 (EudraCT Number: Johnson & Johnson Pharmaceutical Research and Development, L.L.C.)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes