Overview

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