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Efficacy and Safety of Intravenous Neridronic Acid in CRPS

NCT03530345 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 182

Last updated 2020-08-06

Study results available
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Summary

The aim of this trial was to investigate the efficacy and safety of intravenous neridronic acid in subjects with Complex Regional Pain Syndrome (CRPS).

The trial consisted of an Enrollment Period lasting up to 60 days, Treatment Period A consisting of 4 infusions (neridronic acid or placebo) over 10 days, and a Follow-up Period 1 until Week 26.

At Week 26, participants not meeting the pre-specified criteria to continue into Treatment Period B continued in Follow-up Period 2 until Week 52. Participants meeting the pre-specified criteria entered the open-label Treatment Period B with 4 additional infusions (neridronic acid) over 10 days and follow-up visits until Week 52.

Conditions

  • Complex Regional Pain Syndrome (CRPS)

Interventions

DRUG

Neridronic acid 100 mg

100 mg neridronic acid supplied in glass vials in 8 mL of excipients.

DRUG

Placebo

Glass vials with matching placebo.

Sponsors & Collaborators

  • Grünenthal GmbH

    lead INDUSTRY

Principal Investigators

  • Grünenthal Study Director · Grünenthal GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-30
Primary Completion
2019-07-31
Completion
2019-07-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • France
  • Germany
  • New Zealand
  • South Korea
  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03530345 on ClinicalTrials.gov