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

Urologic Diseases Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01060254
• Other study ID #: CR017017
• Secondary ID: 42160443PAI20052
• Status: Terminated
• Phase: Phase 2
• Start date: April 6, 2010
• Est. completion date: June 24, 2011

Study information

• Verified date: October 2021
• Source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 31
• Est. completion date: June 24, 2011
• Est. primary completion date: June 24, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cystitis
• Cystitis, Interstitial
• Urinary Bladder Diseases
• Urologic Diseases

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change in the average pain intensity score.		The change from baseline to the end of the double-blind phase in the mean average pain intensity score (12 weeks).
Secondary	Evaluation of Global Response Assessment (GRA)		12 weeks
Secondary	Changes from baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI)		12 weeks
Secondary	Change in Pelvic Pain and Urgency/Frequency Questionnaire (PUF)		12 weeks
Secondary	Changes from baseline to end of the double-blind phase in subscale scores of the Short Form (SF)-12 Health Survey		12 weeks
Secondary	Antibody against JNJ-42160443		34 weeks