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

Primary Purpose

Cystitis, Interstitial, Urologic Diseases, Urinary Bladder Diseases

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo
JNJ-42160443
Sponsored by
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystitis, Interstitial focused on measuring Interstitial cystitis (IC) and/or painful bladder syndrome (PBS)-related pain, Moderate to severe chronic bladder pain, JNJ-42160443

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

JNJ-42160443

Placebo

Arm Description

Outcomes

Primary Outcome Measures

The change in the average pain intensity score.

Secondary Outcome Measures

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

Full Information

First Posted
January 29, 2010
Last Updated
October 15, 2021
Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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1. Study Identification

Unique Protocol Identification Number
NCT01060254
Brief Title
A Study to Evaluate the Pain Relieving Effects, Safety, and Tolerability of JNJ-42160443 for the Relief of Bladder Pain
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Terminated
Why Stopped
Logistic reasons associated with the FDA-imposed clinical hold.
Study Start Date
April 6, 2010 (Actual)
Primary Completion Date
June 24, 2011 (Actual)
Study Completion Date
June 24, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystitis, Interstitial, Urologic Diseases, Urinary Bladder Diseases, Cystitis
Keywords
Interstitial cystitis (IC) and/or painful bladder syndrome (PBS)-related pain, Moderate to severe chronic bladder pain, JNJ-42160443

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
JNJ-42160443
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Form=solution for injection, route=Subcutaneous injection. One injection of matching placebo every 28 days for up to 12 wks
Intervention Type
Drug
Intervention Name(s)
JNJ-42160443
Intervention Description
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
Primary Outcome Measure Information:
Title
The change in the average pain intensity score.
Time Frame
The change from baseline to the end of the double-blind phase in the mean average pain intensity score (12 weeks).
Secondary Outcome Measure Information:
Title
Evaluation of Global Response Assessment (GRA)
Time Frame
12 weeks
Title
Changes from baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI)
Time Frame
12 weeks
Title
Change in Pelvic Pain and Urgency/Frequency Questionnaire (PUF)
Time Frame
12 weeks
Title
Changes from baseline to end of the double-blind phase in subscale scores of the Short Form (SF)-12 Health Survey
Time Frame
12 weeks
Title
Antibody against JNJ-42160443
Time Frame
34 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Organizational Affiliation
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Official's Role
Study Director
Facility Information:
City
Birmingham
State/Province
Alabama
Country
United States
City
Phoenix
State/Province
Arizona
Country
United States
City
Glendora
State/Province
California
Country
United States
City
San Diego
State/Province
California
Country
United States
City
Aventura
State/Province
Florida
Country
United States
City
Eagle
State/Province
Idaho
Country
United States
City
Jeffersonville
State/Province
Indiana
Country
United States
City
Kansas City
State/Province
Kansas
Country
United States
City
Overland Park
State/Province
Kansas
Country
United States
City
Metairie
State/Province
Louisiana
Country
United States
City
New Orleans
State/Province
Louisiana
Country
United States
City
Shreveport
State/Province
Louisiana
Country
United States
City
Brighton
State/Province
Massachusetts
Country
United States
City
Royal Oak
State/Province
Michigan
Country
United States
City
Englewood
State/Province
New Jersey
Country
United States
City
Poughkeepsie
State/Province
New York
Country
United States
City
Greensboro
State/Province
North Carolina
Country
United States
City
Winston-Salem
State/Province
North Carolina
Country
United States
City
Arlington
State/Province
Texas
Country
United States
City
Fair Oaks Ranch
State/Province
Texas
Country
United States
City
Barrie
State/Province
Ontario
Country
Canada
City
Kingston
State/Province
Ontario
Country
Canada
City
Kitchener
State/Province
Ontario
Country
Canada
City
North York
State/Province
Ontario
Country
Canada
City
Toronto
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
32734597
Citation
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.
Results Reference
derived
PubMed Identifier
28056917
Citation
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.
Results Reference
derived

Learn more about this trial

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

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