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

NCT ID: NCT01060254

Last Updated: 2021-10-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-06
• Study Completion Date: 2011-06-24

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.

Conditions

Cystitis, Interstitial; Urologic Diseases; Urinary Bladder Diseases; Cystitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

JNJ-42160443

Group Type: EXPERIMENTAL

JNJ-42160443

Intervention Type: DRUG

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

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Form=solution for injection, route=Subcutaneous injection. One injection of matching placebo every 28 days for up to 12 wks

Interventions

Placebo

Form=solution for injection, route=Subcutaneous injection. One injection of matching placebo every 28 days for up to 12 wks

Intervention Type: 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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

Role: STUDY_DIRECTOR

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Locations

Birmingham, Alabama, United States

Phoenix, Arizona, United States

Glendora, California, United States

San Diego, California, United States

Aventura, Florida, United States

Eagle, Idaho, United States

Jeffersonville, Indiana, United States

Kansas City, Kansas, United States

Overland Park, Kansas, United States

Metairie, Louisiana, United States

New Orleans, Louisiana, United States

Shreveport, Louisiana, United States

Brighton, Massachusetts, United States

Royal Oak, Michigan, United States

Englewood, New Jersey, United States

Poughkeepsie, New York, United States

Greensboro, North Carolina, United States

Winston-Salem, North Carolina, United States

Arlington, Texas, United States

Fair Oaks Ranch, Texas, United States

Barrie, Ontario, Canada

Kingston, Ontario, Canada

Kitchener, Ontario, Canada

North York, Ontario, Canada

Toronto, Ontario, Canada

Countries

United States; Canada

References

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.

Reference Type: DERIVED

PMID: 32734597 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28056917 (View on PubMed)

Other Identifiers

42160443PAI2005

Identifier Type: OTHER

Identifier Source: secondary_id

2009-009856-19

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR017017

Identifier Type: -

Identifier Source: org_study_id