NCT02746068
Unknown
Phase 3
COAST -1: Clinical Knee Osteoarthritis Symptom Treatment 1 Study. A Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of AXS-02 (Disodium Zoledronate Tetrahydrate) Administered Orally to Subjects With Knee Osteoarthritis Associated With Bone Marrow Lesions.
Overview
- Phase
- Phase 3
- Intervention
- AXS-02
- Conditions
- Osteoarthritis, Knee
- Sponsor
- Axsome Therapeutics, Inc.
- Enrollment
- 346
- Locations
- 3
- Primary Endpoint
- Change in patient reported pain intensity
- Last Updated
- 7 years ago
Overview
Brief Summary
This is a randomized, double-blind, placebo-controlled, 24-week study to evaluate the efficacy and safety of AXS-02 in subjects with knee osteoarthritis associated with bone marrow lesions.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male at least 50 years of age, or postmenopausal female
- •Meets the ACR clinical criteria for knee osteoarthritis
- •Bone Marrow Lesion of the knee present on MRI
- •Additional criteria may apply
Exclusion Criteria
- •Previous surgery on index knee
- •Any prior use of bisphosphonates within 6 months of screening
- •Additional criteria may apply
Arms & Interventions
AXS-02
Administered orally in the morning for 6 weeks
Intervention: AXS-02
Placebo
Administered orally in the morning for 6 weeks
Intervention: Placebo
Outcomes
Primary Outcomes
Change in patient reported pain intensity
Time Frame: Baseline to Week 24
Patient reported pain intensity is recorded as an average daily pain intensity using an 11-point scale (0 = no pain to 10 = worst pain possible)
Secondary Outcomes
- Patient Global Impression of Change (PGI-C)(Week 12 and Week 24)
- Change in WOMAC pain and stiffness subscales over time(Baseline to Week 24)
- Clinical Global Impression of Change (CGI-C) scores(Week 12 and Week 24)
Study Sites (3)
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