CREATE-1: A Study to Assess the Efficacy and Safety of AXS-02 in Patients With CRPS-1 (CREATE-1)
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|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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02504008
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