OsteoarthritisPhase 2NCT01094262
A Safety and Tolerability Study of JNJ-42160443 in Patients With Moderate to Severe, Chronic Knee Pain From Osteoarthritis
A Phase 2 study testing Oxycodone CR (standard pain medication) and JNJ-42160443 in people with Osteoarthritis and Osteoarthritis, Knee, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 44 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate pain relief, safety, and tolerability of a new treatment (JNJ-42160443) for moderate to severe pain of osteoarthritis of the knee in comparison to a standard pain treatment and placebo. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Osteoarthritis, Osteoarthritis, Knee, Pain
- What is being tested?
- Oxycodone CR (standard pain medication) and JNJ-42160443
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 196 participants
- Where
- 44 sitesin 2 countries
- Study dates
- 20 Apr 2010to 1 Jul 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of osteoarthritis of the knee
- Have moderate to severe pain based on a trial questionnaire
- Must be on a stable dose of pain medication for 4 weeks before entering the trial
- Medically stable condition
Who cannot join
- History of joint replacement surgery in the affected joint or planned surgery involving the affected joint during the trial
- Diabetes mellitus
- Uncontrolled cardiovascular disease or hypertension
- Previous treatment with another investigational NGF inhibitor therapy
Trial locations and contacts
44 sites in 2 countries.
44 sites in 2 countries
United States36 sites
Study site
Avon, Indiana
Study site
Baton Rouge, Louisiana
Study site
Boise, Idaho
Study site
Carmichael, California
Study site
Clearwater, Florida
Study site
Collegeville, Pennsylvania
Study site
Duncansville, Pennsylvania
Study site
Eagle, Idaho
Study site
Evansville, Indiana
Study site
Grapevine, Texas
Study site
Greenville, North Carolina
Study site
Hallandale, Florida
Study site
Kettering, Ohio
Study site
Lubbock, Texas
Study site
Mamaroneck, New York
Study site
Mandeville, Louisiana
Study site
Marietta, Georgia
Study site
Metairie, Louisiana
Study site
New Orleans, Louisiana
Study site
Odessa, Texas
Study site
Oklahoma City, Oklahoma
Study site
Oldsmar, Florida
Study site
Omaha, Nebraska
Study site
Perry, Georgia
Study site
Pismo Beach, California
Study site
Raleigh, North Carolina
Study site
Richardson, Texas
Study site
San Antonio, Texas
Study site
Shreveport, Louisiana
Study site
St Louis, Missouri
Study site
St. Petersburg, Florida
Study site
Tampa, Florida
Study site
Tucson, Arizona
Study site
Watertown, Massachusetts
Study site
Williamsville, New York
Study site
Woodstock, Georgia
Canada8 sites
Study site
Corunna, Ontario
Study site
Greater Sudbury, Ontario
Study site
London, Ontario
Study site
Montreal, Quebec
Study site
Newmarket, Ontario
Study site
Québec, Quebec
Study site
Sarnia, Ontario
Study site
Toronto, Ontario
About this study
Official title: A Randomized, Double-Blind, Placebo- and Active-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of JNJ-42160443 as Monotherapy in Subjects With Moderate to Severe, Chronic Knee Pain From Osteoarthritis
The purpose of this study is to evaluate pain relief, safety, and tolerability of a new treatment (JNJ-42160443) for moderate to severe pain of osteoarthritis of the knee in comparison to a standard pain treatment and placebo.
Read the detailed description
This is a double-blind (neither the physician nor the patient knows the name of the assigned drug) study evaluating pain relief, safety, and tolerability of a new treatment (JNJ-42160443) for moderate to severe pain of osteoarthritis of the knee in comparison to a standard pain treatment and placebo. The study will last for about 42 weeks. Patients will receive treatment for 16 weeks. Patients who qualify for the study based on their level of pain as well as other factors will receive one of the 4 possible treatments as determined by chance. Before entering the study, patients must stop using their present pain medication. During the study, patients will answer questions about their pain, side effects, and have tests performed to monitor their physical condition. The main purpose of the study is to compare pain relief with JNJ-42160443 to that of a standard pain treatment or placebo. After the treatment period, patients can return to taking the pain medication that they used before the start of the study, and their physical condition will continue to be monitored. JNJ 42160443 10 mg/mL will be provided for use in the study. Patients will receive 1 of 4 treatments for 16 weeks (wks): lower dosage of JNJ 42160443 by subcutaneous (under the skin) (SC) injection once every 4 wks + Placebo (P) capsule orally (by mouth) (PO) 2x/day, higher dosage of JNJ 42160443 by SC injection once every 4 wks + P capsule PO 2x/day, standard pain medication capsule PO 2x/day + P by SC injection once every 4 wks, or P capsule PO 2x/day + P by SC injection once every 4 wks.
- Conditions
- Osteoarthritis, Osteoarthritis, Knee, Pain, Arthralgia, Joint Pain
- Being tested
- Oxycodone CR (standard pain medication), JNJ-42160443, Placebo
- Keywords
- Osteoarthritis pain of the knee, Osteoarthritis, Osteoarthritis, Knee, Pain, Arthralgia, Joint Pain, JNJ-42160443
- Medical subject headings
- Osteoarthritis, Osteoarthritis, Knee, Pain, Arthralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxycodone CR (standard pain medication)Drug
Oxycodone CR: Type=exact number, unit=mg, number= 10-50, form=capsule, route=oral use and Placebo: Form=solution for injection, route=Subcutaneous use. Oxycodone CR capsule twice a day for 16 weeks and one placebo injection every 4 weeks for 16 weeks.
JNJ-42160443Drug
JNJ-42160443: Type=exact number, unit=mg, number= 3, form=solution for injection, route=Subcutaneous use and Placebo: Form=capsule, route=Oral use. One injection of JNJ-42160443 every 4 weeks and a placebo capsule twice a day for 16 weeks.
JNJ-42160443Drug
JNJ-42160443: Type=exact number, unit=mg, number= 9, form=solution for injection, route=Subcutaneous use and Placebo: Form=capsule, route=Oral use. One injection of JNJ-42160443 every 4 weeks and a placebo capsule twice a day for 16 weeks.
PlaceboDrug
Form=solution for injection, route=Subcutaneous use and Form=capsule, route=Oral use. One placebo injection every 4 weeks and a placebo capsule twice a day for 16 weeks.
| Study group | Role | What they receive |
|---|---|---|
| JNJ-42160443 (lower dose) | Experimental | Not described Receives: Drug: JNJ-42160443 |
| JNJ-42160443 (higher dose) | Experimental | Not described Receives: Drug: JNJ-42160443 |
| Oxycodone CR (standard pain medication) | Active comparator | Not described Receives: Drug: Oxycodone CR (standard pain medication) |
| 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.
Change in the average daily pain intensity
Measured: From Baseline to Week 13 (ie, after 12 weeks of treatment)
Secondary outcomes (2)
Western Ontario and McMaster Osteoarthritis Index (WOMAC 3.1) subscales scores
The WOMAC 3.1 is a multi-dimensional, osteoarthritis specific questionnaire designed to assess clinically important symptoms of the hip and/or knee.
Measured: 12 weeks
Patient Global Assessment (PGA) scale score
The PGA is a single item that the patient completes to indicate their perception of their osteoarthritis status, on an 11-point numerical rating scale from 0 (Very Good) to 10 (Very Bad).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2010 (estimated)
- Study start20 Apr 2010
- Primary completion1 Jul 2011
- Study completion1 Jul 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 (1)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies 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
- 196 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
- NCT01094262
- Sponsor's protocol ID
- CR017092
- Other IDs
- 42160443-PAI2006, 2009-016831-36, 2009
- Status last verified
- Mar 2020
- First submitted
- 25 Mar 2010
- Last updated
- 11 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
Publications
Mayorga AJ, Wang S, Kelly KM, Thipphawong J. Efficacy and safety of fulranumab as monotherapy in patients with moderate to severe, chronic knee pain of primary osteoarthritis: a randomised, placebo- and active-controlled trial. Int J Clin Pract. 2016 Jun;70(6):493-505. doi: 10.1111/ijcp.12807.
PubMed 27238963
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo- and Active-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of JNJ-42160443 as Monotherapy in Subjects With Moderate to Severe, Chronic Knee Pain From Osteoarthritis
- ClinicalTrials.gov ID
- NCT01094262
- Acronym / sponsor ID
- CR017092
- Conditions
- Osteoarthritis, Osteoarthritis, Knee, Pain, Arthralgia, Joint Pain
- Keywords
- Osteoarthritis pain of the knee, Osteoarthritis, Osteoarthritis, Knee, Pain, Arthralgia, Joint Pain, JNJ-42160443
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Logistic reasons associated with the FDA-imposed clinical hold.
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- 20 Apr 2010 (actual)
- Primary completion
- 1 Jul 2011 (actual)
- Study completion
- 1 Jul 2011 (actual)
- First posted
- 26 Mar 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 pain relief, safety, and tolerability of a new treatment (JNJ-42160443) for moderate to severe pain of osteoarthritis of the knee in comparison to a standard pain treatment and placebo.
Detailed description
This is a double-blind (neither the physician nor the patient knows the name of the assigned drug) study evaluating pain relief, safety, and tolerability of a new treatment (JNJ-42160443) for moderate to severe pain of osteoarthritis of the knee in comparison to a standard pain treatment and placebo. The study will last for about 42 weeks. Patients will receive treatment for 16 weeks. Patients who qualify for the study based on their level of pain as well as other factors will receive one of the 4 possible treatments as determined by chance. Before entering the study, patients must stop using their present pain medication. During the study, patients will answer questions about their pain, side effects, and have tests performed to monitor their physical condition. The main purpose of the study is to compare pain relief with JNJ-42160443 to that of a standard pain treatment or placebo. After the treatment period, patients can return to taking the pain medication that they used before the start of the study, and their physical condition will continue to be monitored. JNJ 42160443 10 mg/mL will be provided for use in the study. Patients will receive 1 of 4 treatments for 16 weeks (wks): lower dosage of JNJ 42160443 by subcutaneous (under the skin) (SC) injection once every 4 wks + Placebo (P) capsule orally (by mouth) (PO) 2x/day, higher dosage of JNJ 42160443 by SC injection once every 4 wks + P capsule PO 2x/day, standard pain medication capsule PO 2x/day + P by SC injection once every 4 wks, or P capsule PO 2x/day + P by SC injection once every 4 wks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| JNJ-42160443 (lower dose) | Experimental | Drug: JNJ-42160443 |
| JNJ-42160443 (higher dose) | Experimental | Drug: JNJ-42160443 |
| Oxycodone CR (standard pain medication) | Active comparator | Drug: Oxycodone CR (standard pain medication) |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of osteoarthritis of the knee
- Have moderate to severe pain based on a trial questionnaire
- Must be on a stable dose of pain medication for 4 weeks before entering the trial
- Medically stable condition
Key exclusion criteria (4 listed)
- History of joint replacement surgery in the affected joint or planned surgery involving the affected joint during the trial
- Diabetes mellitus
- Uncontrolled cardiovascular disease or hypertension
- Previous treatment with another investigational NGF inhibitor therapy
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 |
|---|---|---|
| Oxycodone CR (standard pain medication)Oxycodone CR: Type=exact number, unit=mg, number= 10-50, form=capsule, route=oral use and Placebo: Form=solution for injection, route=Subcutaneous use. Oxycodone CR capsule twice a day for 16 weeks and one placebo injection every 4 weeks for 16 weeks. | Drug | Oxycodone CR (standard pain medication) |
| JNJ-42160443JNJ-42160443: Type=exact number, unit=mg, number= 3, form=solution for injection, route=Subcutaneous use and Placebo: Form=capsule, route=Oral use. One injection of JNJ-42160443 every 4 weeks and a placebo capsule twice a day for 16 weeks. | Drug | JNJ-42160443 (lower dose) |
| JNJ-42160443JNJ-42160443: Type=exact number, unit=mg, number= 9, form=solution for injection, route=Subcutaneous use and Placebo: Form=capsule, route=Oral use. One injection of JNJ-42160443 every 4 weeks and a placebo capsule twice a day for 16 weeks. | Drug | JNJ-42160443 (higher dose) |
| PlaceboForm=solution for injection, route=Subcutaneous use and Form=capsule, route=Oral use. One placebo injection every 4 weeks and a placebo capsule twice a day for 16 weeks. | Drug | Placebo |
Primary outcome
Change in the average daily pain intensity
Time frame: From Baseline to Week 13 (ie, after 12 weeks of treatment)
2 secondary outcomes
Western Ontario and McMaster Osteoarthritis Index (WOMAC 3.1) subscales scores
Time frame: 12 weeks
Patient Global Assessment (PGA) scale score
Time frame: 12 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 11 Mar 2020.
- Derived from this study: PubMed 27238963Mayorga AJ, Wang S, Kelly KM, Thipphawong J. Efficacy and safety of fulranumab as monotherapy in patients with moderate to severe, chronic knee pain of primary osteoarthritis: a randomised, placebo- and active-controlled trial. Int J Clin Pract. 2016 Jun;70(6):493-505. doi: 10.1111/ijcp.12807.
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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.
44 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 Oxycodone CR (standard pain medication) and JNJ-42160443 in people with Osteoarthritis and Osteoarthritis, Knee, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 44 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 4 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 11 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 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?
Change in the average daily pain intensity (time frame: From Baseline to Week 13 (ie, after 12 weeks of treatment)). 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 NCT01094262, which also lists 1 linked publication.
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 11 Mar 2020.