A Study of ARRY-371797 in Patients With Osteoarthritis of the Knee

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Array BioPharma
ClinicalTrials.gov Identifier:
NCT01366014
First received: June 2, 2011
Last updated: June 6, 2013
Last verified: June 2013

June 2, 2011
June 6, 2013
June 2011
June 2012   (final data collection date for primary outcome measure)
Assess the efficacy of the study drug (versus placebo) in terms of change from baseline to week 4 in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score (index knee). [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01366014 on ClinicalTrials.gov Archive Site
  • Assess the efficacy of the study drug (versus placebo) in terms of change from baseline to week 4 in the WOMAC stiffness and physical function subscale scores (index knee). [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, electrocardiograms and vital signs. [ Time Frame: 5 weeks ] [ Designated as safety issue: Yes ]
  • Characterize the pharmacokinetics of the study drug and metabolite as determined by plasma concentrations. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of ARRY-371797 in Patients With Osteoarthritis of the Knee
Not Provided

This is a Phase 2 study, involving a 4-week treatment period, designed to test the ability of investigational study drug ARRY-371797 to reduce pain in patients with moderate to severe pain due to osteoarthritis (OA) of the knee, and to further evaluate the drug's safety. Approximately 150 patients from the US will be enrolled in this study.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Osteoarthritis of the Knee
  • Drug: ARRY-371797, p38 inhibitor; oral
    multiple dose, single schedule
  • Drug: Oxycodone hydrochloride (HCl) extended release (ER), opioid agonist; oral
    multiple dose, single schedule
  • Drug: Placebo; oral
    matching placebo
  • Experimental: ARRY-371797
    Intervention: Drug: ARRY-371797, p38 inhibitor; oral
  • Active Comparator: Oxycodone HCl ER
    Intervention: Drug: Oxycodone hydrochloride (HCl) extended release (ER), opioid agonist; oral
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo; oral
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
157
June 2012
June 2012   (final data collection date for primary outcome measure)

Key Inclusion Criteria:

  • Diagnosis of OA of the knee, based on American College of Rheumatology (ACR) criteria, confirmed by X-ray (K-L Grade II/III within the last year).
  • At least moderate or severe pain due to OA in one knee.
  • On nonsteroidal anti-inflammatory drug (NSAID) 28 days previous to study start and willing to continue on NSAID throughout study.
  • Discontinuation of opioids prior to study start.
  • Additional criteria exist.

Key Exclusion Criteria:

  • Current or recent infection in the last 7 days; infection requiring hospitalization or parenteral antibiotics within the last 6 months; history of or currently active tuberculosis, hepatitis B or C, or human immunodeficiency virus (HIV).
  • Surgery on the index knee within the previous 6 months.
  • Trauma or other surgeries within the previous 8 weeks.
  • Specific abnormal laboratory values or electrocardiogram abnormalities.
  • Gastrointestinal surgery that may interfere with motility or absorption.
  • On non-stable dose of bisphosphonates, or any prior denosumab or parathyroid hormone (PTH) therapies.
  • Prior parenteral tumor necrosis factor (TNF) inhibitor or anti-nerve growth factor (NGF) therapies.
  • Intramuscular, intravenous or oral corticosteroids within the previous 6 weeks.
  • Intra-articular corticosteroids in the index knee within the previous 8 weeks or viscosupplementation in the index knee within the previous 4 months.
  • Currently enrolled in or participated in another clinical trial within the previous 3 months.
  • Additional criteria exist.
Both
40 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01366014
ARRAY-797-223
No
Array BioPharma
Array BioPharma
Not Provided
Not Provided
Array BioPharma
June 2013

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