drugset / Trial / NCT02402530

Efficacy and Safety of Intravenous Neridronic Acid in CRPS-I

NCT02402530 ↗

Phase 2/3 Completed 459 enrolled Grünenthal GmbH
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2015-04
Primary completion
2016-08
Completion
2016-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Neridronic acid Unknown 62.5 mg Intravenous