NCT02402530

Efficacy and Safety of Intravenous Neridronic Acid in CRPS-I

A Randomized, Double-blind Trial Investigating the Efficacy and Safety of Intravenous Neridronic Acid in Subjects With Complex Regional Pain Syndrome Type I (CRPS-I)

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 459 (actual)
• Sponsor: Grünenthal GmbH · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Complex Regional Pain Syndrome, Type I

Interventions

Type	Name	Description
DRUG	Placebo	Matching placebo administered as intravenous infusion.
DRUG	Neridronic acid 62.5 mg	Neridronic acid administered as intravenous infusion.

Timeline

• Start date: 2015-04-01
• Primary completion: 2016-08-01
• Completion: 2016-11-01
• First posted: 2015-03-30
• Last updated: 2018-05-09

Locations

59 sites across 3 countries: United States, Germany, United Kingdom

Regulatory

• FDA-regulated drug study