Efficacy and Safety of Intravenous Neridronic Acid in CRPS-I (NCT02402530) | Clinical Trial Compass
CompletedPhase 2/3
Efficacy and Safety of Intravenous Neridronic Acid in CRPS-I
United States459 participantsStarted 2015-04
Plain-language summary
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.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion Criteria:
* Informed consent signed.
* Male or female participant between 18 years and 80 years of age.
* A diagnosis of complex regional pain syndrome type I according to the clinical diagnostic criteria using the International Association for the Study of Pain clinical diagnostic criteria (Budapest criteria).
* Baseline Pain Intensity Score of 4 or greater using an 11-point Numerical Rating Scale referring to the CRPS-affected limb.
* In stable treatment and follow-up therapy for CRPS type I for at least 1 month.
* Participant has undergone a recent regular dental examination.
* Women of child-bearing potential must have a negative urine ß-HCG pregnancy test at enrollment.
* Women of child-bearing potential must practice protocol defined acceptable methods of birth control during the trial.
* Participants must be able to communicate meaningfully, be able to differentiate with regard to location and intensity of the pain, and be able to answer the questions in the questionnaires used in this trial.
* Compliance with the use of electronic diary assessed prior to allocation to treatment.
Exclusion Criteria:
* A diagnosis of complex regional pain syndrome type II.
* Documented history or diagnosis of peripheral neuropathy, including diabetic peripheral neuropathy or other metabolic or toxic neuropathy, or any other chronic pain condition that would significantly affect a participant's ability to report CRPS-related pain.
* Body weight less than 40 kg.
* Evidence of…