Study Stopped
Logistic reasons associated with the FDA-imposed clinical hold.
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
3 other identifiers
interventional
31
2 countries
25
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Apr 2010
Shorter than P25 for phase_2
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 29, 2010
CompletedFirst Posted
Study publicly available on registry
February 2, 2010
CompletedStudy Start
First participant enrolled
April 6, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 24, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 24, 2011
CompletedOctober 18, 2021
October 1, 2021
1.2 years
January 29, 2010
October 15, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
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
Study Arms (2)
JNJ-42160443
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Form=solution for injection, route=Subcutaneous injection. One injection of matching placebo every 28 days for up to 12 wks
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Unknown Facility
Birmingham, Alabama, United States
Unknown Facility
Phoenix, Arizona, United States
Unknown Facility
Glendora, California, United States
Unknown Facility
San Diego, California, United States
Unknown Facility
Aventura, Florida, United States
Unknown Facility
Eagle, Idaho, United States
Unknown Facility
Jeffersonville, Indiana, United States
Unknown Facility
Kansas City, Kansas, United States
Unknown Facility
Overland Park, Kansas, United States
Unknown Facility
Metairie, Louisiana, United States
Unknown Facility
New Orleans, Louisiana, United States
Unknown Facility
Shreveport, Louisiana, United States
Unknown Facility
Brighton, Massachusetts, United States
Unknown Facility
Royal Oak, Michigan, United States
Unknown Facility
Englewood, New Jersey, United States
Unknown Facility
Poughkeepsie, New York, United States
Unknown Facility
Greensboro, North Carolina, United States
Unknown Facility
Winston-Salem, North Carolina, United States
Unknown Facility
Arlington, Texas, United States
Unknown Facility
Fair Oaks Ranch, Texas, United States
Unknown Facility
Barrie, Ontario, Canada
Unknown Facility
Kingston, Ontario, Canada
Unknown Facility
Kitchener, Ontario, Canada
Unknown Facility
North York, Ontario, Canada
Unknown Facility
Toronto, Ontario, Canada
Related Publications (2)
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.
PMID: 32734597DERIVEDWang 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.
PMID: 28056917DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 29, 2010
First Posted
February 2, 2010
Study Start
April 6, 2010
Primary Completion
June 24, 2011
Study Completion
June 24, 2011
Last Updated
October 18, 2021
Record last verified: 2021-10