A Phase 2 interventional study of Placebo and JNJ-42160443 in Cystitis, Interstitial, Urologic Diseases and Urinary Bladder Diseases, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.. Terminated at 25 sites in 2 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-10-18.
Sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (part of Johnson & Johnson) · Phase 2, Interventional, and Treatment
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.
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.
236 studies on the registry are indexed under Cystitis, Interstitial; 35 are open to participants now.
This study's enrollment of 31 is below the median of 51 across 158 interventional studies indexed under Cystitis, Interstitial.
Browse Cystitis, Interstitial studies →Johnson & Johnson Pharmaceutical Research & Development, L.L.C. is the lead sponsor of 465 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: JNJ-42160443
Drug: Placebo
Form=solution for injection, route=Subcutaneous injection. One injection of matching placebo every 28 days for up to 12 wks
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
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).
Evaluation of Global Response Assessment (GRA)
Time frame: 12 weeks
Changes from baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI)
Time frame: 12 weeks
Change in Pelvic Pain and Urgency/Frequency Questionnaire (PUF)
Time frame: 12 weeks
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
Antibody against JNJ-42160443
Time frame: 34 weeks
Ran from Apr 2010 to primary completion in Jun 2011, 14 months.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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