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

• Status: Terminated
• Trial end date: 2011-06-24
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

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

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