CREATE-1: A Study to Assess the Efficacy and Safety of AXS-02 in Patients With CRPS-1
CREATE-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)
1 other identifier
interventional
190
4 countries
44
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jul 2015
Typical duration for phase_3
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2015
CompletedFirst Submitted
Initial submission to the registry
July 20, 2015
CompletedFirst Posted
Study publicly available on registry
July 21, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2019
CompletedMarch 23, 2018
March 1, 2018
3.5 years
July 20, 2015
March 21, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 12
Secondary Outcomes (6)
Change in Brief Pain Inventory (BPI) Pain Score
Baseline to Week 12
Patients' Global Impression of Change (PGI-C)
Baseline to Week 12
Clinicians' Global Impression of Change (CGI-C)
Baseline to Week 12
Change in EuroQOL 5-dimensions questionnaire (EQ-5D)
Baseline to Week 12
Change in Short-Form McGill Pain Questionnaire (SF-MPQ-2)
Baseline to Week 12
- +1 more secondary outcomes
Study Arms (2)
AXS-02 (oral zoledronate)
EXPERIMENTALAdministered orally in the morning on Days 1, 8, 15, 22, 29, and 36
Placebo
PLACEBO COMPARATORAdministered orally in the morning on Day 1, 8, 15, 22, 29, and 36
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (44)
Unknown Facility
Tucson, Arizona, United States
Unknown Facility
Hot Springs, Arkansas, United States
Unknown Facility
Encinitas, California, United States
Unknown Facility
La Jolla, California, United States
Unknown Facility
Los Angeles, California, United States
Unknown Facility
Napa, California, United States
Unknown Facility
Temecula, California, United States
Unknown Facility
Denver, Colorado, United States
Unknown Facility
Clermont, Florida, United States
Unknown Facility
Miami, Florida, United States
Unknown Facility
Orlando, Florida, 32827, United States
Unknown Facility
Tampa, Florida, United States
Unknown Facility
West Palm Beach, Florida, United States
Unknown Facility
Canton, Georgia, United States
Unknown Facility
Marietta, Georgia, United States
Unknown Facility
St. Marys, Georgia, 31558, United States
Unknown Facility
Meridian, Idaho, United States
Unknown Facility
Chicago, Illinois, United States
Unknown Facility
Louisville, Kentucky, United States
Unknown Facility
Albuquerque, New Mexico, United States
Unknown Facility
New York, New York, United States
Unknown Facility
Winston-Salem, North Carolina, United States
Unknown Facility
Oklahoma City, Oklahoma, United States
Unknown Facility
Portland, Oregon, United States
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Dallas, Texas, United States
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San Antonio, Texas, United States
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Bellevue, Washington, United States
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Seattle, Washington, United States
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Madison, Wisconsin, United States
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Broadmeadow, New South Wales, Australia
Unknown Facility
Hurstville, New South Wales, Australia
Unknown Facility
Noosa, Queensland, Australia
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Welland, South Australia, Australia
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Clayton, Victoria, Australia
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Nedlands, Western Australia, Australia
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Sherbrooke, Quebec, Canada
Unknown Facility
Warrington, Cheshire, United Kingdom
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Darlington, County Durham, United Kingdom
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Lambeth, London, United Kingdom
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Liverpool, Merseyside, United Kingdom
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Norwich, Norfolk, United Kingdom
Unknown Facility
Newcastle upon Tyne, Tyne and Wear, United Kingdom
Unknown Facility
Glasgow, United Kingdom
Unknown Facility
London, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 20, 2015
First Posted
July 21, 2015
Study Start
July 1, 2015
Primary Completion
January 1, 2019
Study Completion
January 1, 2019
Last Updated
March 23, 2018
Record last verified: 2018-03