A Study to Assess the Efficacy and Safety of AXS-02 in Su... | NCT02746068

Official Title

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.

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AXS-02	Experimental	Administered orally in the morning for 6 weeks	Drug: AXS-02
Placebo	Placebo Comparator	Administered orally in the morning for 6 weeks	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
AXS-02	Drug		AXS-02
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in patient reported pain intensity	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)	Baseline to Week 24

Secondary Outcomes

Measure	Description	Time Frame
Patient Global Impression of Change (PGI-C)		Week 12 and Week 24
Clinical Global Impression of Change (CGI-C) scores		Week 12 and Week 24
Change in WOMAC pain and stiffness subscales over time

Eligibility Module

Contacts/Locations Module

Facility	Status	City	State	ZIP	Country	Contacts
Achieve Clinical Research		Birmingham	Alabama	35216	United States

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D020370	Osteoarthritis, Knee
D010003	Osteoarthritis

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases