Trial | NCT02504008  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    zoledronic acid ...

  • Study Participants

    190
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.
Study Started
Jul 31
2015
Primary Completion
Jan 31
2019
Anticipated
Study Completion
Jan 31
2019
Anticipated
Last Update
Mar 23
2018

Drug AXS-02 (oral zoledronate)

Once weekly for 6 weeks

Drug Placebo

Once weekly for 6 weeks

AXS-02 (oral zoledronate) Experimental

Administered orally in the morning on Days 1, 8, 15, 22, 29, and 36

Placebo Placebo Comparator

Administered orally in the morning on Day 1, 8, 15, 22, 29, and 36

Criteria 

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
No Results Posted