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

Sponsor

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

Overall Status

Terminated

CT.gov ID

NCT00973141

Collaborator

(none)

467

Enrollment

Locations

Arms

21.4

Actual Duration (Months)

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 knee or hip pain in patients with a diagnosis of osteoarthritis.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis Osteoarthritis, Hip Osteoarthritis, Knee Pain Arthralgia Joint Pain	Drug: JNJ-42160443 Drug: JNJ-42160443 Drug: JNJ-42160443 Drug: Placebo Drug: JNJ-42160443 Drug: JNJ-42160443	Phase 2

Detailed Description

This current study 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 osteoarthritis of the hip or the knee who have moderate to severe pain that is not controlled by standard pain medications.Osteoarthritis is a chronic disease that affects the joints, and is characterized by degeneration of cartilage and bone. The duration of the study is approximately 133 weeks (3-week screening phase, 12-week double-blind efficacy phase, 92-week double-blind extension phase, and 26-week post treatment phase).JNJ-42160443 (10 mg/mL) or matching placebo given as an subcutaneous (injection under the skin) (SC) once every 4 weeks will be administered in the study as 1 of 5 JNJ-42160443 dosages:1 mg every 4 weeks, 3 mg every 4 weeks, 3 mg every 8 weeks, 6 mg every 8 weeks; or 10 mg every 8 weeks, or matching placebo for up to approximately 104 weeks (12-week double-blind efficacy phase + 92-week double-blind extension phase).

Study Design

Study Type:

Interventional

Actual Enrollment :

467 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-42160443 as Adjunctive Therapy in Subjects With Moderate to Severe Knee or Hip Pain From Osteoarthritis

Actual Study Start Date :

Sep 16, 2009

Actual Primary Completion Date :

Jun 30, 2011

Actual Study Completion Date :

Jun 30, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: JNJ-42160443 1mg every 4 weeks	Drug: JNJ-42160443 Type=exact number, unit=mg, number=1, form=solution for injection, route=Subcutaneous use. One injection of 1 mg of JNJ-42160443 every 4 weeks for up to 104 weeks (JNJ-42160443 at a concentration of 10 mg/mL was provided for use in this study).
Experimental: JNJ-42160443 3mg every 4 weeks	Drug: JNJ-42160443 Type=exact number, unit=mg, number=3, form=solution for injection, route=Subcutaneous use. One injection of 3 mg of JNJ-42160443 every 4 weeks for up to 104 weeks (JNJ-42160443 at a concentration of 10 mg/mL was provided for use in this study).
Experimental: JNJ-42160443 3mg every 8 weeks	Drug: JNJ-42160443 Type=exact number, unit=mg, number=3, form=solution for injection, route=Subcutaneous use. One injection of 3 mg of JNJ-42160443 every 8 weeks for up to 104 weeks (JNJ-42160443 at a concentration of 10 mg/mL was provided for use in this study).
Experimental: JNJ-42160443 6mg every 8 weeks	Drug: JNJ-42160443 Type=exact number, unit=mg, number=6, form=solution for injection, route=Subcutaneous use. One injection of 6 mg of JNJ-42160443 every 8 weeks for up to 104 weeks (JNJ-42160443 at a concentration of 10 mg/mL was provided for use in this study).
Experimental: JNJ-42160443 10mg every 8 weeks	Drug: JNJ-42160443 Type=exact number, unit=mg, number=10, form=solution for injection, route=Subcutaneous use. One injection of 10 mg of JNJ-42160443 every 8 weeks for up to 104 weeks (JNJ-42160443 at a concentration of 10 mg/mL was provided for use in this study).
Placebo Comparator: Matching placebo every 4 or 8 weeks	Drug: Placebo Form=solution for injection, route=Subcutaneous injection. One injection of matching placebo every 4 or 8 weeks for up to 104 weeks.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Change from baseline in average OA-related pain intensity scores [At Weeks 4 and 8 and over the entire double-blind efficacy phase]
Change from baseline in Pain, stiffness, and function subscales of the WOMAC 3.1 [At the end of the 12-week double-blind efficacy phase]
Change from baseline in Pain severity and pain interference subscales of the BPI SF [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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diagnosis of osteoarthritis of the hip or the knee; Have an average daily pain intensity score of >=5 averaged over the last 3 days before treatment assignment; Receiving a stable dose of non-steroidal anti-inflammatory drugs for a minimum of 5 days each week for the 4 weeks before screening or a stable dose of immediate-release opioids for a minimum of 5 days each week for the 4 weeks before screening, but not exceeding 200 mg oral morphine equivalents per day or a stable dose of long acting opioids for the 4 weeks before screening; but not exceeding 200 mg oral morphine equivalents per day; Have a mini mental state examination score of >=26 at screening. 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, 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), study joint 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	Carmichael	California	United States
5	Fresno	California	United States
6	Garden Grove	California	United States
7	Pismo Beach	California	United States
8	Roseville	California	United States
9	San Diego	California	United States
10	Clearwater	Florida	United States
11	Jacksonville	Florida	United States
12	Oldsmar	Florida	United States
13	Port Orange	Florida	United States
14	Tampa	Florida	United States
15	Woodstock	Georgia	United States
16	Boise	Idaho	United States
17	Meridian	Idaho	United States
18	Evansville	Indiana	United States
19	Indianapolis	Indiana	United States
20	Newburgh	Indiana	United States
21	Valparaiso	Indiana	United States
22	West Des Moines	Iowa	United States
23	Prairie Village	Kansas	United States
24	Topeka	Kansas	United States
25	Louisville	Kentucky	United States
26	Baton Rouge	Louisiana	United States
27	Lake Charles	Louisiana	United States
28	Mandeville	Louisiana	United States
29	Metairie	Louisiana	United States
30	New Orleans	Louisiana	United States
31	Rockville	Maryland	United States
32	Hyannis	Massachusetts	United States
33	Watertown	Massachusetts	United States
34	East Lansing	Michigan	United States
35	Omaha	Nebraska	United States
36	Albuquerque	New Mexico	United States
37	New York	New York	United States
38	Williamsville	New York	United States
39	Greenville	North Carolina	United States
40	Raleigh	North Carolina	United States
41	Toledo	Ohio	United States
42	Oklahoma City	Oklahoma	United States
43	Duncansville	Pennsylvania	United States
44	Austin	Texas	United States
45	Bedford	Texas	United States
46	Dallas	Texas	United States
47	Odessa	Texas	United States
48	San Antonio	Texas	United States
49	Salt Lake City	Utah	United States
50	West Jordan	Utah	United States
51	Roanoke	Virginia	United States
52	Spokane	Washington	United States
53	Burnaby	British Columbia	Canada
54	Kamloops	British Columbia	Canada
55	Kelowna	British Columbia	Canada
56	Penticton	British Columbia	Canada
57	St. John'S	Newfoundland and Labrador	Canada
58	Brampton	Ontario	Canada
59	Cambridge	Ontario	Canada
60	London	Ontario	Canada
61	Mississauga	Ontario	Canada
62	Newmarket	Ontario	Canada
63	Sarnia	Ontario	Canada
64	Sudbury	Ontario	Canada
65	Toronto	Ontario	Canada
66	Montreal	Quebec	Canada
67	Sherbrooke	Quebec	Canada
68	Quebec		Canada
69	Busan		Korea, Republic of
70	Dae-Gu		Korea, Republic of
71	Daegu		Korea, Republic of
72	Gwangju-Si		Korea, Republic of
73	Bialystok		Poland
74	Elblag		Poland
75	Gdynia		Poland
76	Lublin		Poland
77	Torun		Poland
78	Warszawa		Poland

Sponsors and Collaborators

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

Investigators

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