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

NCT01060254

TerminatedPhase 2

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

Conditions: Cystitis, Interstitial, Urologic Diseases, Urinary Bladder Diseases, Cystitis

Interventions: Placebo, JNJ-42160443

Countries: United States, Canada

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 80 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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
Locations (25)
  • 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