NCT02402530 is a Phase 2/Phase 3 clinical trial of Neridronic acid 62.5 mg in Complex Regional Pain Syndrome, Type I, sponsored by Grünenthal GmbH.

Who is sponsoring NCT02402530?

NCT02402530 is sponsored by Grünenthal GmbH.

What drugs are being tested in NCT02402530?

Interventions in NCT02402530: Placebo, Neridronic acid 62.5 mg.

What condition does NCT02402530 study?

NCT02402530 studies Complex Regional Pain Syndrome, Type I.

Is NCT02402530 still recruiting?

NCT02402530 is currently completed. Last updated 8 May 2018.

Last reviewed 2018-05-08 · How we verify

NCT02402530

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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)

Completed Phase 2/Phase 3 Last updated 8 May 2018

What this trial tests

Phase 2/Phase 3 trial testing Placebo in Complex Regional Pain Syndrome, Type I in 459 participants. Completed in 1 November 2016.

Timeline

1 April 2015

Primary endpoint
1 August 2016

1 November 2016

Quick facts

Lead sponsor	Grünenthal GmbH
Phase	Phase 2/Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	459
Start date	1 April 2015
Primary completion	1 August 2016
Estimated completion	1 November 2016
Sites	59 locations across United States, Germany, United Kingdom

Drugs / interventions tested

Placebo
Neridronic acid 62.5 mg — full drug profile →

Conditions studied

Complex Regional Pain Syndrome, Type I — all drugs for Complex Regional Pain Syndrome, Type I →

Sponsor

Grünenthal GmbH — full company profile →

Who can join

Adults 18 to 80, any sex, with Complex Regional Pain Syndrome, Type I. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Change in the Pain Intensity Score to Week 12.
Time frame: Baseline; 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.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Intramuscular neridronate for the treatment of complex regional pain syndrome type 1: a randomized, double-blind, placebo-controlled study.
Varenna M, Braga V, Gatti D, Iolascon G, et al · · 2021 · cited 28× · PMID 34178124 · DOI 10.1177/1759720x211014020

Verify or expand the search:

Other Grünenthal GmbH trials

Trials by the same sponsor.

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NCT07289776 — A First-in-human Trial of GRT7041 in Healthy Participants · Phase 1 · recruiting
NCT07317063 — A Trial to Investigate Safety and Pharmacokinetics of GRT6019, Including Food Effect, in Healthy Male Participants · Phase 1 · completed
NCT05449132 — Comparison of a Single RTX-GRT7039 and Placebo Intra-articular Injection for Pain Associated With Osteoarthritis of the · Phase 3 · completed
NCT05377489 — Open-label Trial to Check the Safety and Tolerability of RTX-GRT7039 Injections for Pain Associated With Osteoarthritis · Phase 3 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02402530 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Grünenthal GmbH
Last refreshed: 8 May 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02402530.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing