A Safety and Tolerability Study of JNJ-42160443 in Patients With Moderate to Severe, Chronic Knee Pain From Osteoarthritis

Sponsor

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

Overall Status

Terminated

CT.gov ID

NCT01094262

Collaborator

(none)

196

Enrollment

Locations

Arms

14.4

Actual Duration (Months)

4.5

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate pain relief, safety, and tolerability of a new treatment (JNJ-42160443) for moderate to severe pain of osteoarthritis of the knee in comparison to a standard pain treatment and placebo.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis Osteoarthritis, Knee Pain Arthralgia Joint Pain	Drug: Oxycodone CR (standard pain medication) Drug: JNJ-42160443 Drug: JNJ-42160443 Drug: Placebo	Phase 2

Detailed Description

This is a double-blind (neither the physician nor the patient knows the name of the assigned drug) study evaluating pain relief, safety, and tolerability of a new treatment (JNJ-42160443) for moderate to severe pain of osteoarthritis of the knee in comparison to a standard pain treatment and placebo. The study will last for about 42 weeks. Patients will receive treatment for 16 weeks. Patients who qualify for the study based on their level of pain as well as other factors will receive one of the 4 possible treatments as determined by chance. Before entering the study, patients must stop using their present pain medication. During the study, patients will answer questions about their pain, side effects, and have tests performed to monitor their physical condition. The main purpose of the study is to compare pain relief with JNJ-42160443 to that of a standard pain treatment or placebo. After the treatment period, patients can return to taking the pain medication that they used before the start of the study, and their physical condition will continue to be monitored. JNJ 42160443 10 mg/mL will be provided for use in the study. Patients will receive 1 of 4 treatments for 16 weeks (wks): lower dosage of JNJ 42160443 by subcutaneous (under the skin) (SC) injection once every 4 wks + Placebo (P) capsule orally (by mouth) (PO) 2x/day, higher dosage of JNJ 42160443 by SC injection once every 4 wks + P capsule PO 2x/day, standard pain medication capsule PO 2x/day + P by SC injection once every 4 wks, or P capsule PO 2x/day + P by SC injection once every 4 wks.

Study Design

Study Type:

Interventional

Actual Enrollment :

196 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Randomized, Double-Blind, Placebo- and Active-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of JNJ-42160443 as Monotherapy in Subjects With Moderate to Severe, Chronic Knee Pain From Osteoarthritis

Actual Study Start Date :

Apr 20, 2010

Actual Primary Completion Date :

Jul 1, 2011

Actual Study Completion Date :

Jul 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: JNJ-42160443 (lower dose)	Drug: JNJ-42160443 JNJ-42160443: Type=exact number, unit=mg, number= 3, form=solution for injection, route=Subcutaneous use and Placebo: Form=capsule, route=Oral use. One injection of JNJ-42160443 every 4 weeks and a placebo capsule twice a day for 16 weeks.
Experimental: JNJ-42160443 (higher dose)	Drug: JNJ-42160443 JNJ-42160443: Type=exact number, unit=mg, number= 9, form=solution for injection, route=Subcutaneous use and Placebo: Form=capsule, route=Oral use. One injection of JNJ-42160443 every 4 weeks and a placebo capsule twice a day for 16 weeks.
Active Comparator: Oxycodone CR (standard pain medication)	Drug: Oxycodone CR (standard pain medication) Oxycodone CR: Type=exact number, unit=mg, number= 10-50, form=capsule, route=oral use and Placebo: Form=solution for injection, route=Subcutaneous use. Oxycodone CR capsule twice a day for 16 weeks and one placebo injection every 4 weeks for 16 weeks.
Placebo Comparator: Placebo	Drug: Placebo Form=solution for injection, route=Subcutaneous use and Form=capsule, route=Oral use. One placebo injection every 4 weeks and a placebo capsule twice a day for 16 weeks.

Outcome Measures

Primary Outcome Measures

Change in the average daily pain intensity [From Baseline to Week 13 (ie, after 12 weeks of treatment)]

Secondary Outcome Measures

Western Ontario and McMaster Osteoarthritis Index (WOMAC 3.1) subscales scores [12 weeks]
The WOMAC 3.1 is a multi-dimensional, osteoarthritis specific questionnaire designed to assess clinically important symptoms of the hip and/or knee.
Patient Global Assessment (PGA) scale score [12 weeks]
The PGA is a single item that the patient completes to indicate their perception of their osteoarthritis status, on an 11-point numerical rating scale from 0 (Very Good) to 10 (Very Bad).

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Clinical diagnosis of osteoarthritis of the knee
Have moderate to severe pain based on a trial questionnaire
Must be on a stable dose of pain medication for 4 weeks before entering the trial
Medically stable condition

Exclusion Criteria:

History of joint replacement surgery in the affected joint or planned surgery involving the affected joint during the trial
Diabetes mellitus
Uncontrolled cardiovascular disease or hypertension
Previous treatment with another investigational NGF inhibitor therapy

Contacts and Locations

Locations

	City	State	Country
1	Tucson	Arizona	United States
2	Carmichael	California	United States
3	Pismo Beach	California	United States
4	Clearwater	Florida	United States
5	Hallandale Beach	Florida	United States
6	Oldsmar	Florida	United States
7	Saint Petersburg	Florida	United States
8	Tampa	Florida	United States
9	Marietta	Georgia	United States
10	Perry	Georgia	United States
11	Woodstock	Georgia	United States
12	Boise	Idaho	United States
13	Eagle	Idaho	United States
14	Avon	Indiana	United States
15	Evansville	Indiana	United States
16	Baton Rouge	Louisiana	United States
17	Mandeville	Louisiana	United States
18	Metairie	Louisiana	United States
19	New Orleans	Louisiana	United States
20	Shreveport	Louisiana	United States
21	Watertown	Massachusetts	United States
22	Saint Louis	Missouri	United States
23	Omaha	Nebraska	United States
24	Mamaroneck	New York	United States
25	Williamsville	New York	United States
26	Greenville	North Carolina	United States
27	Raleigh	North Carolina	United States
28	Kettering	Ohio	United States
29	Oklahoma City	Oklahoma	United States
30	Collegeville	Pennsylvania	United States
31	Duncansville	Pennsylvania	United States
32	Grapevine	Texas	United States
33	Lubbock	Texas	United States
34	Odessa	Texas	United States
35	Richardson	Texas	United States
36	San Antonio	Texas	United States
37	Corunna	Ontario	Canada
38	London	Ontario	Canada
39	Newmarket	Ontario	Canada
40	Sarnia	Ontario	Canada
41	Sudbury	Ontario	Canada
42	Toronto	Ontario	Canada
43	Montreal	Quebec	Canada
44	Quebec		Canada

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.