Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 42160443PAI2003 | Other Identifier | Johnson & Johnson Pharmaceutical Research and Development, L.L.C. | |
| 2009-009857-17 | EudraCT Number |
Not provided
Not provided
Not provided
Based on lack of efficacy in PAI2003, sponsor made the decision to discontinue the trial.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JNJ-42160443 1 mg | Experimental |
| |
| JNJ-42160443 3 mg | Experimental |
| |
| JNJ-42160443 6 mg/3mg | Experimental |
| |
| JNJ-42160443 10 mg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-42160443 3 mg | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the average low back pain-related pain intensity score | At the end of the 12-week double-blind efficacy phase |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the ODI subscale and total scores | 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 | At the end of the 12-week double-blind efficacy phase |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Johnson & Johnson Pharmaceutical Research & Development, L.L. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27101815 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| JNJ-42160443 1 mg | Drug | 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 | Drug | 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 | Drug | 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 | Drug | Form= solution for injection, route= subcutaneous. Matching placebo given as a subcutaneous (SC) (under the skin) injection (inj) once every 4 weeks (wks). |
|
| Changes in PGA scores | 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 | At the end of the 12-week double-blind efficacy phase |
| Changes in Patient Global Assessment (PGA) scores | At the end of the 12-week double-blind efficacy phase |
| Change from baseline in the Oswestry Disability Index (ODI) subscale and total scores | At the end of the 12-week double-blind efficacy phase |
| 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 |
| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000592179 | fulranumab |
Not provided
Not provided
Not provided