Clinical trial NCT01060254: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: 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
Lead sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Sponsor class: INDUSTRY
First posted: 2010-02-02
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The change in the average pain intensity score.
timeFrame: The change from baseline to the end of the double-blind phase in the mean average pain intensity score (12 weeks).
Secondary outcomes:
measure: Evaluation of Global Response Assessment (GRA)
timeFrame: 12 weeks
measure: Changes from baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI)
timeFrame: 12 weeks
measure: Change in Pelvic Pain and Urgency/Frequency Questionnaire (PUF)
timeFrame: 12 weeks
measure: Changes from baseline to end of the double-blind phase in subscale scores of the Short Form (SF)-12 Health Survey
timeFrame: 12 weeks
measure: Antibody against JNJ-42160443
timeFrame: 34 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Glendora
country: United States
state: California
city: San Diego
country: United States
state: California
city: Aventura
country: United States
state: Florida
city: Eagle
country: United States
state: Idaho
city: Jeffersonville
country: United States
state: Indiana
city: Kansas City
country: United States
state: Kansas
city: Overland Park
country: United States
state: Kansas
city: Metairie
country: United States
state: Louisiana
city: New Orleans
country: United States
state: Louisiana
city: Shreveport
country: United States
state: Louisiana
city: Brighton
country: United States
state: Massachusetts
city: Royal Oak
country: United States
state: Michigan
city: Englewood
country: United States
state: New Jersey
city: Poughkeepsie
country: United States
state: New York
city: Greensboro
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Arlington
country: United States
state: Texas
city: Fair Oaks Ranch
country: United States
state: Texas
city: Barrie
country: Canada
state: Ontario
city: Kingston
country: Canada
state: Ontario
city: Kitchener
country: Canada
state: Ontario
city: North York
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
Study officials:
affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
name: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
role: STUDY_DIRECTOR
References:
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.
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.