Cystitis, InterstitialPhase 2NCT01060254
A Study to Evaluate the Pain Relieving Effects, Safety, and Tolerability of JNJ-42160443 for the Relief of Bladder Pain
A Phase 2 study testing JNJ-42160443 in people with Cystitis, Interstitial and Urologic Diseases, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 25 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cystitis, Interstitial, Urologic Diseases, Urinary Bladder Diseases
- What is being tested?
- JNJ-42160443
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 25 sitesin 2 countries
- Study dates
- 6 Apr 2010to 24 Jun 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
25 sites in 2 countries.
25 sites in 2 countries
United States20 sites
Study site
Arlington, Texas
Study site
Aventura, Florida
Study site
Birmingham, Alabama
Study site
Brighton, Massachusetts
Study site
Eagle, Idaho
Study site
Englewood, New Jersey
Study site
Fair Oaks Ranch, Texas
Study site
Glendora, California
Study site
Greensboro, North Carolina
Study site
Jeffersonville, Indiana
Study site
Kansas City, Kansas
Study site
Metairie, Louisiana
Study site
New Orleans, Louisiana
Study site
Overland Park, Kansas
Study site
Phoenix, Arizona
Study site
Poughkeepsie, New York
Study site
Royal Oak, Michigan
Study site
San Diego, California
Study site
Shreveport, Louisiana
Study site
Winston-Salem, North Carolina
Canada5 sites
Study site
Barrie, Ontario
Study site
Kingston, Ontario
Study site
Kitchener, Ontario
Study site
North York, Ontario
Study site
Toronto, Ontario
About this study
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
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.
Read the detailed 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.
- Being tested
- Placebo, JNJ-42160443
- Keywords
- Interstitial cystitis (IC) and/or painful bladder syndrome (PBS)-related pain, Moderate to severe chronic bladder pain, JNJ-42160443
- Medical subject headings
- Cystitis, Interstitial, Urologic Diseases, Urinary Bladder Diseases, Cystitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Form=solution for injection, route=Subcutaneous injection. One injection of matching placebo every 28 days for up to 12 wks
JNJ-42160443Drug
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
| Study group | Role | What they receive |
|---|---|---|
| JNJ-42160443 | Experimental | Not described Receives: Drug: JNJ-42160443 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in the average pain intensity score.
Measured: The change from baseline to the end of the double-blind phase in the mean average pain intensity score (12 weeks).
Secondary outcomes (5)
Evaluation of Global Response Assessment (GRA)
Measured: 12 weeks
Changes from baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI)
Measured: 12 weeks
Change in Pelvic Pain and Urgency/Frequency Questionnaire (PUF)
Measured: 12 weeks
Changes from baseline to end of the double-blind phase in subscale scores of the Short Form (SF)-12 Health Survey
Measured: 12 weeks
Antibody against JNJ-42160443
Measured: 34 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2010 (estimated)
- Study start6 Apr 2010
- Primary completion24 Jun 2011
- Study completion24 Jun 2011
Why it stopped: Logistic reasons associated with the FDA-imposed clinical hold.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cystitis, InterstitialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01060254
- Sponsor's protocol ID
- CR017017
- Other IDs
- 42160443PAI2005, 2009-009856-19, 2009
- Status last verified
- Oct 2021
- First submitted
- 29 Jan 2010
- Last updated
- 18 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
Publications
Imamura M, Scott NW, Wallace SA, Ogah JA, Ford AA, Dubos YA, Brazzelli M. Interventions for treating people with symptoms of bladder pain syndrome: a network meta-analysis. Cochrane Database Syst Rev. 2020 Jul 30;7(7):CD013325. doi: 10.1002/14651858.CD013325.pub2.
PubMed 32734597Wang H, Russell LJ, Kelly KM, Wang S, Thipphawong J. Fulranumab in patients with interstitial cystitis/bladder pain syndrome: observations from a randomized, double-blind, placebo-controlled study. BMC Urol. 2017 Jan 5;17(1):2. doi: 10.1186/s12894-016-0193-z.
PubMed 28056917
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01060254
- Acronym / sponsor ID
- CR017017
- Keywords
- Interstitial cystitis (IC) and/or painful bladder syndrome (PBS)-related pain, Moderate to severe chronic bladder pain, JNJ-42160443
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Logistic reasons associated with the FDA-imposed clinical hold.
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- 6 Apr 2010 (actual)
- Primary completion
- 24 Jun 2011 (actual)
- Study completion
- 24 Jun 2011 (actual)
- First posted
- 2 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JNJ-42160443 | Experimental | Drug: JNJ-42160443 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboForm=solution for injection, route=Subcutaneous injection. One injection of matching placebo every 28 days for up to 12 wks | Drug | Placebo |
| JNJ-42160443Type=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 | Drug | JNJ-42160443 |
Primary outcome
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).
5 secondary outcomes
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
Results and safety
The study was stopped early (reason given: Logistic reasons associated with the FDA-imposed clinical hold.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2021.
- Derived from this study: PubMed 32734597Imamura M, Scott NW, Wallace SA, Ogah JA, Ford AA, Dubos YA, Brazzelli M. Interventions for treating people with symptoms of bladder pain syndrome: a network meta-analysis. Cochrane Database Syst Rev. 2020 Jul 30;7(7):CD013325. doi: 10.1002/14651858.CD013325.pub2.
- Derived from this study: PubMed 28056917Wang H, Russell LJ, Kelly KM, Wang S, Thipphawong J. Fulranumab in patients with interstitial cystitis/bladder pain syndrome: observations from a randomized, double-blind, placebo-controlled study. BMC Urol. 2017 Jan 5;17(1):2. doi: 10.1186/s12894-016-0193-z.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
25 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing JNJ-42160443 in people with Cystitis, Interstitial and Urologic Diseases, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 25 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Logistic reasons associated with the FDA-imposed clinical hold.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01060254, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2021.