This clinical trial is being conducted to demonstrate the efficacy of neridronic acid in the treatment of pain associated with complex regional pain syndrome type I (CRPS-I). The trial is divided into 3 periods: a 60-day enrollment period, a 12-week trial period, and an extended follow-up period with visits at Month 6, Month 9, and Month 12. The extended follow-up period will be terminated for all participants after the last participant enrolled completes their Month 6 visit (Visit 9). The double-blind will be maintained throughout the 12-week trial period and extended follow-up period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
459
Matching placebo administered as intravenous infusion.
Neridronic acid administered as intravenous infusion.
Change in the Pain Intensity Score to Week 12.
The Pain Intensity Score is the mean value of current pain intensity ratings, obtained twice-daily for 1 week, using an 11-point numerical rating scale where 0 = "no pain" and 10 = "pain as bad as you can imagine". All pain intensity ratings for the primary endpoint will be in reference to the CRPS-affected limb.
Time frame: Baseline; Week 12
Response to treatment: Proportion of Participants With at Least 30 Percent Reduction in the Pain Intensity Score
Participants with at least a 30 percent decrease in the Pain Intensity Score will be considered to have responded to treatment. The Pain Intensity Score is determined as for the primary endpoint.
Time frame: Baseline; Week 12
Response to treatment: Proportion of Participants With at Least 50 Percent Reduction in the Pain Intensity Score
Participants with at least a 50 percent decrease in the Pain Intensity Score will be considered to have responded to treatment. The Pain Intensity Score is determined as for the primary endpoint.
Time frame: Baseline; Week 12
Change in the Brief Pain Inventory (BPI) Interference Score
The BPI Interference Score is the mean value of 7 self-reported items in question 9 of the BPI Short Form Questionnaire. Participants will rate their interference of pain with general activity, walking, work, sleep and other activities in the past 24 hours, with possible ratings from 0 (does not interfere) to 10 (completely interferes). The BPI interference Score ranges from 0 to 10, with higher values indicating greater pain interference of daily activities.
Time frame: Baseline; Week 12
Patient Global Impression of Change (PGIC)
The PGIC is a self-reported measure of perceived change in overall condition since the start of the study. Participants will select one of seven responses ranging from very much improved to very much worse. A response of very much improved or much improved is generally regarded as a clinically important outcome.
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Site US119 - G & L Research
Foley, Alabama, United States
Site US117 - Valley Pain Consultants
Scottsdale, Arizona, United States
Site US116 - Arizona Pain Specialists
Scottsdale, Arizona, United States
Site US124 - Quality of Life Medical and Research Centers LLC
Tucson, Arizona, United States
Site US154 - Woodland International Research Group
Little Rock, Arkansas, United States
Site US110 - Orange County Research Institute
Anaheim, California, United States
Site US172 - Core Healthcare Group
Cerritos, California, United States
Site US108 - Catalina Research Institute
Chino, California, United States
Site US175 - Inland Pain Medicine
Colton, California, United States
Site US152 - UC San Diego Healthcare Systems, Center for Pain Medicine
La Jolla, California, United States
...and 49 more locations
Time frame: Baseline; Week 12
Change in the EuroQol-5 Dimension 5 Level (EQ-5D-5L) Index Score
The EQ-5D-5L Index Score describes the participant's overall health status and is derived from self-reported scores in 5 health dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Participants will rate each dimension 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). The EQ-5D-5L Index Score ranges from 0 to 1, with 0 representing death and 1.0 representing perfect health.
Time frame: Baseline; Week 12
Change in the EuroQol Visual Analog Scale (EQ VAS)
The EQ VAS is a self-reported measure of the participant's overall health "today". Participants will place a mark on a 20 cm vertical scale numbered from 0 to 100, with 0 labeled as "the worst health you can imagine" and 100 labeled as "the best health you can imagine". The EQ VAS ranges from 0 to 100, with higher scores representing better overall health.
Time frame: Baseline; Week 12