CREATE-1: A Study to Assess the Efficacy and Safety of AXS-02 in Patients With CRPS-1



Status:Active, not recruiting
Conditions:Chronic Pain, Orthopedic, Pain
Therapuetic Areas:Musculoskeletal, Orthopedics / Podiatry
Healthy:No
Age Range:18 - Any
Updated:4/17/2018
Start Date:July 2015
End Date:January 2019

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CREATE-1 Study: CRPS Treatment Evaluation 1 Study. A Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of AXS-02 (Oral Zoledronate) Administered Orally to Subjects With Complex Regional Pain Syndrome Type I (CRPS-I)

This is a randomized, double-blind, placebo-controlled, 24-week study to evaluate the
efficacy and safety of AXS-02 in patients with CRPS-I.


Key Inclusion Criteria:

- Male or female of at least 18 years of age

- Recently confirmed diagnosis of CRPS-1 (Budapest criteria)

- Average pain intensity score of ≥ 5 (based on an 11-point scale [0 - 10])

- Willing and able to provide written informed consent

Key Exclusion Criteria:

- Received chronic opioid therapy within 4 weeks

- Received a sympathetic nerve block within 3 weeks

- Active litigation or a pending workers' compensation decision

- Any other clinically significant medical or pain condition (eg, Parkinson's disease,
cognitive impairment, or fibromyalgia) or clinical laboratory abnormality that would
in the investigator's judgment interfere with the subject's ability to participate in
the study
We found this trial at
30
sites
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