Low Back PainPhase 2NCT00973024
A Dose-ranging Study of the Safety and Effectiveness of JNJ-42160443 as add-on Treatment in Patients With Low Back Pain
A Phase 2 study testing JNJ-42160443 3 mg, JNJ-42160443 1 mg and JNJ-42160443 6 mg/3mg in people with Low Back Pain and Low Back Pain, Recurrent, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 60 sites in 4 countries.
Trial summary
The purpose of this study is to compare the safety and effectiveness of different doses of JNJ-42160443 with placebo in the treatment of chronic, moderate to severe low back pain patients with a diagnosis of chronic low back pain. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Low Back Pain, Low Back Pain, Recurrent
- What is being tested?
- JNJ-42160443 3 mg, JNJ-42160443 1 mg and JNJ-42160443 6 mg/3mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 389 participants
- Where
- 60 sitesin 4 countries
- Study dates
- Sep 2009to May 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
- Diagnosis of chronic low back pain
Who cannot join
- Pain with radiation to the extremity and with neurologic signs
- history within the past year of any of the following: seizure disorder
- intrathecal therapy and ventricular shunts, mild or moderate traumatic brain injury, stroke, or transient ischemic attack, meningitis
- History of brain injury within the past 15 years consisting of >= 1 of the following, or with residual sequalae suggesting transient changes in consciousness: brain contusion, intracranial hematoma, either unconsciousness or posttraumatic amnesia lasting more than 24 hours
- History of epilepsy or multiple sclerosis
- Current diagnosis of fibromyalgia, complex regional pain syndrome (including reflex sympathetic dystrophy or causalgia), acute spinal cord compression, bowel or bladder dysfunction as a result of cauda equine compression, back pain caused by secondary infection, or pain caused by confirmed or suspected neoplasm
- Any new or unresolved neurologic deficits, including progressive deficits, within 6 months before screening
Trial locations and contacts
60 sites in 4 countries.
60 sites in 4 countries
United States41 sites
Study site
Augusta, Georgia
Study site
Austin, Texas
Study site
Baton Rouge, Louisiana
Study site
Birmingham, Alabama
Study site
Boise, Idaho
Study site
Dallas, Texas
Study site
Duncansville, Pennsylvania
Study site
Eagle, Idaho
Study site
East Lansing, Michigan
Study site
Evansville, Indiana
Study site
Hickory, North Carolina
Study site
Hollywood, Florida
Study site
Indianapolis, Indiana
Study site
Lake Charles, Louisiana
Study site
Little Rock, Arkansas
Study site
Metairie, Louisiana
Study site
New Orleans, Louisiana
Study site
Newburgh, Indiana
Study site
Oklahoma City, Oklahoma
Study site
Oldsmar, Florida
Study site
Phoenix, Arizona
Study site
Pismo Beach, California
Study site
Port Orange, Florida
Study site
Prairie Village, Kansas
Study site
Raleigh, North Carolina
Study site
Renton, Washington
Study site
Roanoke, Virginia
Study site
Salt Lake City, Utah
Study site
San Antonio, Texas
Study site
San Diego, California
Study site
Tampa, Florida
Study site
Toledo, Ohio
Study site
Topeka, Kansas
Study site
Tucson, Arizona
Study site
Valparaiso, Indiana
Study site
Virginia Beach, Virginia
Study site
Watertown, Massachusetts
Study site
West Des Moines, Iowa
Study site
West Jordan, Utah
Study site
Williamsville, New York
Study site
Woodstock, Georgia
Canada15 sites
Study site
Brampton, Ontario
Study site
Greater Sudbury, Ontario
Study site
Kelowna, British Columbia
Study site
London, Ontario
Study site
Mississauga, Ontario
Study site
Montreal, Quebec
Study site
Newmarket, Ontario
Study site
Penticton, British Columbia
Study site
Québec, Quebec
Study site
Sarnia, Ontario
Study site
Sherbrooke, Quebec
Study site
St. John's, Newfoundland and Labrador
Study site
Toronto, Ontario
Study site
Trois-Rivières, Quebec
Study site
Waterloo, Ontario
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Dose-Loading Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-42160443 as Adjunctive Therapy in Subjects With Inadequately Controlled, Moderate to Severe, Chronic Low Back Pain
The purpose of this study is to compare the safety and effectiveness of different doses of JNJ-42160443 with placebo in the treatment of chronic, moderate to severe low back pain patients with a diagnosis of chronic low back pain.
Read the detailed description
This 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 safety and effectiveness of different doses of JNJ-42160443 compared with placebo in the treatment of patients with a diagnosis of chronic low back pain who have moderate to severe, chronic low back pain that is not controlled by standard pain medications. JNJ-42160443 (10 mg/ml) or matching placebo given as a subcutaneous (SC) (under the skin) injection (inj) once every 4 weeks (wks); one of four JNJ-42160443 doses (1 mg every 4 wks; 3 mg every 4 wks; 6 mg loading dose on Day 1 followed by 3 mg every 4 wks; or 10 mg every 4 wks, or matching placebo for up to 104 wks (12-wk double-blind efficacy period + 92-wk double-blind extension period).
- Conditions
- Low Back Pain, Low Back Pain, Recurrent
- Being tested
- JNJ-42160443 3 mg, JNJ-42160443 1 mg, JNJ-42160443 6 mg/3mg, JNJ-42160443 10 mg, Matching Placebo
- Keywords
- JNJ-42160443, Low back pain-related pain, moderate to severe, chronic pain
- Medical subject headings
- Low Back Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-42160443 3 mgDrug
JNJ-42160443: type=exact number, unit=mg, number= 3, form=solution for injection, route=Subcutaneous use or Placebo: form=solution for injection, route=Subcutaneous injection. One inj of 3 mg of JNJ-42160443 or matching placebo every 4 wks for up to 104 wks.
JNJ-42160443 1 mgDrug
JNJ-42160443: type=exact number, unit=mg, number= 1, form=solution for injection, route=Subcutaneous use or Placebo: form=solution for injection, route=Subcutaneous injection. One inj of 1 mg of JNJ-42160443 or matching placebo every 4 wks for up to 104 wks.
JNJ-42160443 6 mg/3mgDrug
JNJ-42160443: type= exact number, unit= mg, number= 3 and 6, form=solution for injection, route= Subcutaneous use or Placebo: form= solution for injection, route= Subcutaneous injection. 1 inj of 6 mg of JNJ-42160443 on Day 1 followed by 1 inj of 3 mg or matching placebo every 4 wks for up to 104 wks.
JNJ-42160443 10 mgDrug
JNJ-42160443 10 mg: type=exact number, unit=mg, number= 10, form=solution for injection, route=Subcutaneous use or Placebo: form=solution for injection, route=Subcutaneous injection. One inj of 10 mg of JNJ-42160443 or matching placebo every 4 wks for up to 104 wks.
Matching PlaceboDrug
Form= solution for injection, route= subcutaneous. Matching placebo given as a subcutaneous (SC) (under the skin) injection (inj) once every 4 weeks (wks).
| Study group | Role | What they receive |
|---|---|---|
| JNJ-42160443 1 mg | Experimental | Not described Receives: Drug: JNJ-42160443 1 mg; Drug: Matching Placebo |
| JNJ-42160443 3 mg | Experimental | Not described Receives: Drug: JNJ-42160443 3 mg; Drug: Matching Placebo |
| JNJ-42160443 6 mg/3mg | Experimental | Not described Receives: Drug: JNJ-42160443 6 mg/3mg; Drug: Matching Placebo |
| JNJ-42160443 10 mg | Experimental | Not described Receives: Drug: JNJ-42160443 10 mg; Drug: Matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the average low back pain-related pain intensity score
Measured: At the end of the 12-week double-blind efficacy phase
Secondary outcomes (6)
Change from baseline in the ODI subscale and total scores
Measured: At the end of the 12-week double-blind efficacy phase
Change from baseline in the pain severity and pain interference subscales of the BPI Short Form
Measured: At the end of the 12-week double-blind efficacy phase
Changes in PGA scores
Measured: At the end of the 12-week double-blind efficacy phase
Change from baseline in the pain severity and pain interference subscales of the Brief Pain Inventory (BPI) Short Form
Measured: At the end of the 12-week double-blind efficacy phase
Changes in Patient Global Assessment (PGA) scores
Measured: At the end of the 12-week double-blind efficacy phase
Change from baseline in the Oswestry Disability Index (ODI) subscale and total scores
Measured: At the end of the 12-week double-blind efficacy phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionMay 2011
- Study completionMay 2011
Why it stopped: Based on lack of efficacy in PAI2003, sponsor made the decision to discontinue the trial.
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 Low Back PainStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 389 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. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00973024
- Sponsor's protocol ID
- CR016468
- Other IDs
- 42160443PAI2003, 2009-009857-17, 2009
- Status last verified
- May 2016
- First submitted
- 4 Sep 2009
- Last updated
- 6 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sanga P, Polverejan E, Wang S, Kelly KM, Thipphawong J. Efficacy, Safety, and Tolerability of Fulranumab as an Adjunctive Therapy in Patients With Inadequately Controlled, Moderate-to-Severe Chronic Low Back Pain: A Randomized, Double-blind, Placebo-controlled, Dose-ranging, Dose-loading Phase II Study. Clin Ther. 2016 Jun;38(6):1435-1450. doi: 10.1016/j.clinthera.2016.03.030. Epub 2016 Apr 18.
PubMed 27101815
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Dose-Loading Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-42160443 as Adjunctive Therapy in Subjects With Inadequately Controlled, Moderate to Severe, Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT00973024
- Acronym / sponsor ID
- CR016468
- Conditions
- Low Back Pain, Low Back Pain, Recurrent
- Keywords
- JNJ-42160443, Low back pain-related pain, moderate to severe, chronic pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Based on lack of efficacy in PAI2003, sponsor made the decision to discontinue the trial.
- Enrolment
- 389 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 9 Sep 2009 (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 compare the safety and effectiveness of different doses of JNJ-42160443 with placebo in the treatment of chronic, moderate to severe low back pain patients with a diagnosis of chronic low back pain.
Detailed description
This 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 safety and effectiveness of different doses of JNJ-42160443 compared with placebo in the treatment of patients with a diagnosis of chronic low back pain who have moderate to severe, chronic low back pain that is not controlled by standard pain medications. JNJ-42160443 (10 mg/ml) or matching placebo given as a subcutaneous (SC) (under the skin) injection (inj) once every 4 weeks (wks); one of four JNJ-42160443 doses (1 mg every 4 wks; 3 mg every 4 wks; 6 mg loading dose on Day 1 followed by 3 mg every 4 wks; or 10 mg every 4 wks, or matching placebo for up to 104 wks (12-wk double-blind efficacy period + 92-wk double-blind extension period).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| JNJ-42160443 1 mg | Experimental | Drug: JNJ-42160443 1 mg, Drug: Matching Placebo |
| JNJ-42160443 3 mg | Experimental | Drug: JNJ-42160443 3 mg, Drug: Matching Placebo |
| JNJ-42160443 6 mg/3mg | Experimental | Drug: JNJ-42160443 6 mg/3mg, Drug: Matching Placebo |
| JNJ-42160443 10 mg | Experimental | Drug: JNJ-42160443 10 mg, Drug: Matching Placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of chronic low back pain
Key exclusion criteria (7 listed)
- Pain with radiation to the extremity and with neurologic signs
- history within the past year of any of the following: seizure disorder
- intrathecal therapy and ventricular shunts, mild or moderate traumatic brain injury, stroke, or transient ischemic attack, meningitis
- History of brain injury within the past 15 years consisting of >= 1 of the following, or with residual sequalae suggesting transient changes in consciousness: brain contusion, intracranial hematoma, either unconsciousness or posttraumatic amnesia lasting more than 24 hours
- History of epilepsy or multiple sclerosis
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 |
|---|---|---|
| JNJ-42160443 3 mgJNJ-42160443: type=exact number, unit=mg, number= 3, form=solution for injection, route=Subcutaneous use or Placebo: form=solution for injection, route=Subcutaneous injection. One inj of 3 mg of JNJ-42160443 or matching placebo every 4 wks for up to 104 wks. | Drug | JNJ-42160443 3 mg |
| JNJ-42160443 1 mgJNJ-42160443: type=exact number, unit=mg, number= 1, form=solution for injection, route=Subcutaneous use or Placebo: form=solution for injection, route=Subcutaneous injection. One inj of 1 mg of JNJ-42160443 or matching placebo every 4 wks for up to 104 wks. | Drug | JNJ-42160443 1 mg |
| JNJ-42160443 6 mg/3mgJNJ-42160443: type= exact number, unit= mg, number= 3 and 6, form=solution for injection, route= Subcutaneous use or Placebo: form= solution for injection, route= Subcutaneous injection. 1 inj of 6 mg of JNJ-42160443 on Day 1 followed by 1 inj of 3 mg or matching placebo every 4 wks for up to 104 wks. | Drug | JNJ-42160443 6 mg/3mg |
| JNJ-42160443 10 mgJNJ-42160443 10 mg: type=exact number, unit=mg, number= 10, form=solution for injection, route=Subcutaneous use or Placebo: form=solution for injection, route=Subcutaneous injection. One inj of 10 mg of JNJ-42160443 or matching placebo every 4 wks for up to 104 wks. | Drug | JNJ-42160443 10 mg |
| Matching PlaceboForm= solution for injection, route= subcutaneous. Matching placebo given as a subcutaneous (SC) (under the skin) injection (inj) once every 4 weeks (wks). | Drug | JNJ-42160443 1 mg, JNJ-42160443 10 mg, JNJ-42160443 3 mg, JNJ-42160443 6 mg/3mg |
Primary outcome
Change from baseline in the average low back pain-related pain intensity score
Time frame: At the end of the 12-week double-blind efficacy phase
6 secondary outcomes
Change from baseline in the ODI subscale and total scores
Time frame: At the end of the 12-week double-blind efficacy phase
Change from baseline in the pain severity and pain interference subscales of the BPI Short Form
Time frame: At the end of the 12-week double-blind efficacy phase
Changes in PGA scores
Time frame: At the end of the 12-week double-blind efficacy phase
Change from baseline in the pain severity and pain interference subscales of the Brief Pain Inventory (BPI) Short Form
Time frame: At the end of the 12-week double-blind efficacy phase
Changes in Patient Global Assessment (PGA) scores
Time frame: At the end of the 12-week double-blind efficacy phase
Change from baseline in the Oswestry Disability Index (ODI) subscale and total scores
Time frame: At the end of the 12-week double-blind efficacy phase
Results and safety
The study was stopped early (reason given: Based on lack of efficacy in PAI2003, sponsor made the decision to discontinue the trial.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2016.
- Derived from this study: PubMed 27101815Sanga P, Polverejan E, Wang S, Kelly KM, Thipphawong J. Efficacy, Safety, and Tolerability of Fulranumab as an Adjunctive Therapy in Patients With Inadequately Controlled, Moderate-to-Severe Chronic Low Back Pain: A Randomized, Double-blind, Placebo-controlled, Dose-ranging, Dose-loading Phase II Study. Clin Ther. 2016 Jun;38(6):1435-1450. doi: 10.1016/j.clinthera.2016.03.030. Epub 2016 Apr 18.
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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. Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
60 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing JNJ-42160443 3 mg, JNJ-42160443 1 mg and JNJ-42160443 6 mg/3mg in people with Low Back Pain and Low Back Pain, Recurrent, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 60 sites in 4 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 1 inclusion and 7 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 6 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 60 sites in United States, Canada, Belgium, Netherlands. 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. 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: Based on lack of efficacy in PAI2003, sponsor made the decision to discontinue the trial.). 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 from baseline in the average low back pain-related pain intensity score (time frame: At the end of the 12-week double-blind efficacy phase). 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 NCT00973024, 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 6 Jun 2016.