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

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ClinicalTrials.gov Identifier: NCT01094262
Recruitment Status : Terminated (Logistic reasons associated with the FDA-imposed clinical hold.)
First Posted : March 26, 2010
Last Update Posted : May 2, 2016
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Tracking Information
First Submitted Date  ICMJE March 25, 2010
First Posted Date  ICMJE March 26, 2010
Last Update Posted Date May 2, 2016
Study Start Date  ICMJE April 2010
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 16, 2011)
Change in the average daily pain intensity [ Time Frame: From Baseline to Week 13 (ie, after 12 weeks of treatment) ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 25, 2010)
Change in the average daily pain intensity [ Time Frame: 12 weeks of treatment ]
Change History Complete list of historical versions of study NCT01094262 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 16, 2011)
  • Western Ontario and McMaster Osteoarthritis Index (WOMAC 3.1) subscales scores [ Time Frame: 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 [ Time Frame: 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: March 25, 2010)
  • WOMAC subscales [ Time Frame: 12 weeks ]
  • Patient Global Assessment [ Time Frame: 12 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Safety and Tolerability Study of JNJ-42160443 in Patients With Moderate to Severe, Chronic Knee Pain From Osteoarthritis
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Osteoarthritis
  • Osteoarthritis, Knee
  • Pain
  • Arthralgia
  • Joint Pain
Intervention  ICMJE
  • 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.
  • 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.
  • 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.
  • 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.
Study Arms  ICMJE
  • Experimental: JNJ-42160443 (lower dose)
    Intervention: Drug: JNJ-42160443
  • Experimental: JNJ-42160443 (higher dose)
    Intervention: Drug: JNJ-42160443
  • Active Comparator: Oxycodone CR (standard pain medication)
    Intervention: Drug: Oxycodone CR (standard pain medication)
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Mayorga AJ, Wang S, Kelly KM, Thipphawong J. Efficacy and safety of fulranumab as monotherapy in patients with moderate to severe, chronic knee pain of primary osteoarthritis: a randomised, placebo- and active-controlled trial. Int J Clin Pract. 2016 Jun;70(6):493-505. doi: 10.1111/ijcp.12807.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 13, 2012)
196
Original Estimated Enrollment  ICMJE
 (submitted: March 25, 2010)
300
Actual Study Completion Date  ICMJE July 2011
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01094262
Other Study ID Numbers  ICMJE CR017092
42160443-PAI2006 ( Other Identifier: Johnson & Johnson Pharmaceutical Research and Development, L.L.C. )
2009-016831-36 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Sponsor  ICMJE Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
PRS Account Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP