A Dose-ranging Study of the Safety and Effectiveness of JNJ-42160443 as add-on Treatment in Patients With Low Back Pain

Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (Industry)

Overall Status

Terminated

CT.gov ID

NCT00973024

Collaborator

(none)

389

Enrollment

Locations

Arms

19.9

Duration (Months)

6.5

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Low Back Pain Low Back Pain, Recurrent	Drug: JNJ-42160443 3 mg Drug: JNJ-42160443 1 mg Drug: JNJ-42160443 6 mg/3mg Drug: JNJ-42160443 10 mg Drug: Matching Placebo	Phase 2

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

Study Type:

Interventional

Actual Enrollment :

389 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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

Study Start Date :

Sep 1, 2009

Actual Primary Completion Date :

May 1, 2011

Actual Study Completion Date :

May 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: JNJ-42160443 1 mg	Drug: 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. Drug: 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).
Experimental: JNJ-42160443 3 mg	Drug: 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. Drug: 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).
Experimental: JNJ-42160443 6 mg/3mg	Drug: 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. Drug: 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).
Experimental: JNJ-42160443 10 mg	Drug: 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. Drug: 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).

Outcome Measures

Primary Outcome Measures

Change from baseline in the average low back pain-related pain intensity score [At the end of the 12-week double-blind efficacy phase]

Secondary Outcome Measures

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]
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diagnosis of chronic low back pain

Exclusion Criteria:

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

Contacts and Locations

Locations

	City	State	Country
1	Birmingham	Alabama	United States
2	Phoenix	Arizona	United States
3	Tucson	Arizona	United States
4	Little Rock	Arkansas	United States
5	Pismo Beach	California	United States
6	San Diego	California	United States
7	Hollywood	Florida	United States
8	Oldsmar	Florida	United States
9	Port Orange	Florida	United States
10	Tampa	Florida	United States
11	Augusta	Georgia	United States
12	Woodstock	Georgia	United States
13	Boise	Idaho	United States
14	Eagle	Idaho	United States
15	Evansville	Indiana	United States
16	Indianapolis	Indiana	United States
17	Newburgh	Indiana	United States
18	Valparaiso	Indiana	United States
19	West Des Moines	Iowa	United States
20	Prairie Village	Kansas	United States
21	Topeka	Kansas	United States
22	Baton Rouge	Louisiana	United States
23	Lake Charles	Louisiana	United States
24	Metairie	Louisiana	United States
25	New Orleans	Louisiana	United States
26	Watertown	Massachusetts	United States
27	East Lansing	Michigan	United States
28	Williamsville	New York	United States
29	Hickory	North Carolina	United States
30	Raleigh	North Carolina	United States
31	Toledo	Ohio	United States
32	Oklahoma City	Oklahoma	United States
33	Duncansville	Pennsylvania	United States
34	Austin	Texas	United States
35	Dallas	Texas	United States
36	San Antonio	Texas	United States
37	Salt Lake City	Utah	United States
38	West Jordan	Utah	United States
39	Roanoke	Virginia	United States
40	Virginia Beach	Virginia	United States
41	Renton	Washington	United States
42	Edegem		Belgium
43	Genk		Belgium
44	Leuven		Belgium
45	Kelowna	British Columbia	Canada
46	Penticton	British Columbia	Canada
47	St. John'S	Newfoundland and Labrador	Canada
48	Brampton	Ontario	Canada
49	London	Ontario	Canada
50	Mississauga	Ontario	Canada
51	Newmarket	Ontario	Canada
52	Sarnia	Ontario	Canada
53	Sudbury	Ontario	Canada
54	Toronto	Ontario	Canada
55	Waterloo	Ontario	Canada
56	Montreal	Quebec	Canada
57	Sherbrooke	Quebec	Canada
58	Trois-Rivieres	Quebec	Canada
59	Quebec		Canada
60	Maastricht		Netherlands

Sponsors and Collaborators

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Investigators

Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. Clinical Trial, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.