A Study of ARRY-371797 in Patients With Osteoarthritis of the Knee
NCT01366014
ABOUT THIS STUDY
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- 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
- 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.
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Descriptive Information | ||||
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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 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 of the Knee | |||
Intervention ICMJE |
| |||
Study Arms ICMJE |
| |||
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 | |||
Actual Enrollment ICMJE | 157 | |||
Original Estimated Enrollment ICMJE | 150 | |||
Actual Study Completion Date ICMJE | June 2012 | |||
Actual Primary Completion Date | June 2012 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Key Inclusion Criteria:
Key Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 40 Years to 85 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 | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01366014 | |||
Other Study ID Numbers ICMJE | ARRAY-797-223 C4411007 ( Other Identifier: Pfizer ) | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | October 2020 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |