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

This study has been terminated.
(Logistic reasons associated with the FDA-imposed clinical hold.)
Sponsor:
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT01060254
First received: January 29, 2010
Last updated: August 7, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Cystitis, Interstitial
Urologic Diseases
Urinary Bladder Diseases
Cystitis
 Drug: Placebo
Drug: JNJ-42160443
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • 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). ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluation of Global Response Assessment (GRA) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Changes from baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change in Pelvic Pain and Urgency/Frequency Questionnaire (PUF) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Antibody against JNJ-42160443 [ Time Frame: 34 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 31
Study Start Date: February 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01060254

  Show 25 Study Locations
Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

No publications provided

Responsible Party: Clinical Leader, Johnson & Johnson Pharmaceutical Research and Development, L.L.C.
ClinicalTrials.gov Identifier: NCT01060254     History of Changes
Other Study ID Numbers: CR017017, 42160443PAI2005, 2009-009856-19
Study First Received: January 29, 2010
Last Updated: August 7, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Interstitial cystitis (IC) and/or painful bladder syndrome (PBS)-related pain
Moderate to severe chronic bladder pain
JNJ-42160443

Additional relevant MeSH terms:
Urinary Bladder Diseases
Cystitis
Urologic Diseases
Cystitis, Interstitial

ClinicalTrials.gov processed this record on May 16, 2013