EUCTR2014-004996-22-CZ
Active, not recruiting
Phase 1
A Phase 2a, Randomized, Double-blind, Placebo- and Naproxen-controlled, Parallel-group Study to Assess the Analgesic Efficacy of ASP7692 in Patients with Pain Due to Osteoarthritis of the Knee
ConditionsOsteoarthritis of the kneeMedDRA version: 19.0Level: LLTClassification code 10031165Term: Osteoarthritis kneeSystem Organ Class: 100000004859Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
DrugsNAPROXEN Tablets USP
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Osteoarthritis of the knee
- Sponsor
- Astellas Pharma Europe B.V.
- Enrollment
- 205
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Institutional Review Board (IRB)\-/Independent Ethics Committee (IEC)\-approved written Informed Consent and privacy language as per national regulations.
- •2\. Patient is a male or female patient and aged 18 to 80 years, at screening.
- •3\. Patient has a primary diagnosis of OA of the index knee with symptoms for at least 6 months prior to screening and patient meets American College of Rheumatology clinical classification criteria for OA of the knee, defined by the following.
- •Knee pain and at least 3 of the following 6 (a\-f):
- •a) Age \> 50 years
- •b) Morning stiffness \< 30 minutes
- •c) Crepitus on active motion
- •d) Bony tenderness
- •e) Bony enlargement
- •f) No palpable warmth of synovium
Exclusion Criteria
- •3\.Current or prior clinically significant neurologic disease, including but
- •not limited to peripheral neuropathy, stroke, cognitive impairment and
- •4\.Any clinically significant uncontrolled musculoskeletal disorder (with
- •the exception of OA), cardiovascular, gastrointestinal, endocrinologic
- •(diabetes mellitus is allowed if controlled \[glycated hemoglobin (HbA1c)
- •\= 8\.0%] and no peripheral neuropathy), hematologic, hepatic,
- •immunologic, metabolic, urologic, pulmonary, dermatologic, renal
- •and/or other major disease.
- •5\.Active malignancy or a history of malignancy (except for treated
- •nonmelanoma skin cancer) within the past 5 years.
Outcomes
Primary Outcomes
Not specified
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