CREATE-1: A Study to Assess the Efficacy and Safety of AXS-02 in Patients With CRPS-1 (CREATE-1)
|ClinicalTrials.gov Identifier: NCT02504008|
Recruitment Status : Active, not recruiting
First Posted : July 21, 2015
Last Update Posted : March 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Complex Regional Pain Syndrome Reflex Sympathetic Dystrophy||Drug: AXS-02 (oral zoledronate) Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||190 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||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)|
|Actual Study Start Date :||July 2015|
|Estimated Primary Completion Date :||January 2019|
|Estimated Study Completion Date :||January 2019|
Experimental: AXS-02 (oral zoledronate)
Administered orally in the morning on Days 1, 8, 15, 22, 29, and 36
Drug: AXS-02 (oral zoledronate)
Once weekly for 6 weeks
Placebo Comparator: Placebo
Administered orally in the morning on Day 1, 8, 15, 22, 29, and 36
Once weekly for 6 weeks
- Change in patient reported pain intensity [ Time Frame: Baseline to Week 12 ]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).
- Change in Brief Pain Inventory (BPI) Pain Score [ Time Frame: Baseline to Week 12 ]The BPI is a nine-question survey completed by the patient that assesses quality of life and health status. BPI scores range from 0 to 10, with higher values indicating greater pain.
- Patients' Global Impression of Change (PGI-C) [ Time Frame: Baseline to Week 12 ]The PGI-C is a patient/patient's caregiver rated scale to assess the patients overall treatment response. PGI-C is a 7-point (1-7) scale rated as; very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse.
- Clinicians' Global Impression of Change (CGI-C) [ Time Frame: Baseline to Week 12 ]The CGI-C is an investigator-rated scale to assess the overall treatment response. CGI-C is a 7-point (1-7) scale rated as; very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse.
- Change in EuroQOL 5-dimensions questionnaire (EQ-5D) [ Time Frame: Baseline to Week 12 ]The EQ-5D descriptive system comprised the following 5 dimensions: mobility, self care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated by the patient at one of 5 levels, with level 1 indicating the best health state (no problems) and level 5 indicating worst health state (e.g., unable to walk about).
- Change in Short-Form McGill Pain Questionnaire (SF-MPQ-2) [ Time Frame: Baseline to Week 12 ]The SF-MPQ-2 measures both neuropathic and nonneuropathic pain. It contains a total of 22 descriptors, which are rated on an intensity scale of 0 = None, to 10 = Worst Possible.
- Change in bone turnover markers [ Time Frame: Baseline to Week 52 ]Bone turnover is measured from 2 biomarkers collected from peripheral blood samples: serum carboxy terminal telopeptide of collagen type I (CTX) and serum procollagen type I N terminal propeptide (s-P1NP).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02504008
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