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: July 17, 2012

Last verified: July 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	June 2, 2011
Last Updated Date	July 17, 2012
Start Date ^ICMJE	June 2011
Primary Completion Date	June 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 2, 2011)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01366014 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 2, 2011)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Study of ARRY-371797 in Patients With Osteoarthritis of the Knee
Official Title ^ICMJE	Not Provided
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Osteoarthritis of the Knee
Intervention ^ICMJE	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
Study Arm (s)	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
Publications *	Not Provided
* 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	Completed
Enrollment ^ICMJE	157
Completion Date	June 2012
Primary Completion Date	June 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	40 Years to 85 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01366014
Other Study ID Numbers ^ICMJE	ARRAY-797-223
Has Data Monitoring Committee	No
Responsible Party	Array BioPharma
Study Sponsor ^ICMJE	Array BioPharma
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Array BioPharma
Verification Date	July 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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