A Dose-ranging Study of the Safety and Effectiveness of JNJ-42160443 as add-on Treatment in Patients With Low Back Pain
NCT ID: NCT00973024
Last Updated: 2016-06-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
389 participants
INTERVENTIONAL
2009-09-30
2011-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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JNJ-42160443 1 mg
JNJ-42160443 1 mg
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.
Matching Placebo
Form= solution for injection, route= subcutaneous. Matching placebo given as a subcutaneous (SC) (under the skin) injection (inj) once every 4 weeks (wks).
JNJ-42160443 3 mg
JNJ-42160443 3 mg
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.
Matching Placebo
Form= solution for injection, route= subcutaneous. Matching placebo given as a subcutaneous (SC) (under the skin) injection (inj) once every 4 weeks (wks).
JNJ-42160443 6 mg/3mg
JNJ-42160443 6 mg/3mg
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.
Matching Placebo
Form= solution for injection, route= subcutaneous. Matching placebo given as a subcutaneous (SC) (under the skin) injection (inj) once every 4 weeks (wks).
JNJ-42160443 10 mg
JNJ-42160443 10 mg
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 Placebo
Form= solution for injection, route= subcutaneous. Matching placebo given as a subcutaneous (SC) (under the skin) injection (inj) once every 4 weeks (wks).
Interventions
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JNJ-42160443 3 mg
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 mg
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/3mg
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 mg
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 Placebo
Form= solution for injection, route= subcutaneous. Matching placebo given as a subcutaneous (SC) (under the skin) injection (inj) once every 4 weeks (wks).
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
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Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
INDUSTRY
Responsible Party
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Principal Investigators
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Johnson & Johnson Pharmaceutical Research & Development, L.L. Clinical Trial
Role: STUDY_DIRECTOR
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Locations
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Birmingham, Alabama, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Little Rock, Arkansas, United States
Pismo Beach, California, United States
San Diego, California, United States
Hollywood, Florida, United States
Oldsmar, Florida, United States
Port Orange, Florida, United States
Tampa, Florida, United States
Augusta, Georgia, United States
Woodstock, Georgia, United States
Boise, Idaho, United States
Eagle, Idaho, United States
Evansville, Indiana, United States
Indianapolis, Indiana, United States
Newburgh, Indiana, United States
Valparaiso, Indiana, United States
West Des Moines, Iowa, United States
Prairie Village, Kansas, United States
Topeka, Kansas, United States
Baton Rouge, Louisiana, United States
Lake Charles, Louisiana, United States
Metairie, Louisiana, United States
New Orleans, Louisiana, United States
Watertown, Massachusetts, United States
East Lansing, Michigan, United States
Williamsville, New York, United States
Hickory, North Carolina, United States
Raleigh, North Carolina, United States
Toledo, Ohio, United States
Oklahoma City, Oklahoma, United States
Duncansville, Pennsylvania, United States
Austin, Texas, United States
Dallas, Texas, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
West Jordan, Utah, United States
Roanoke, Virginia, United States
Virginia Beach, Virginia, United States
Renton, Washington, United States
Edegem, , Belgium
Genk, , Belgium
Leuven, , Belgium
Kelowna, British Columbia, Canada
Penticton, British Columbia, Canada
St. John's, Newfoundland and Labrador, Canada
Brampton, Ontario, Canada
Greater Sudbury, Ontario, Canada
London, Ontario, Canada
Mississauga, Ontario, Canada
Newmarket, Ontario, Canada
Sarnia, Ontario, Canada
Toronto, Ontario, Canada
Waterloo, Ontario, Canada
Montreal, Quebec, Canada
Québec, Quebec, Canada
Sherbrooke, Quebec, Canada
Trois-Rivières, Quebec, Canada
Maastricht, , Netherlands
Countries
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References
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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.
Other Identifiers
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42160443PAI2003
Identifier Type: OTHER
Identifier Source: secondary_id
2009-009857-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CR016468
Identifier Type: -
Identifier Source: org_study_id
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