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)

Grünenthal GmbH0 sites225 target enrollmentApril 7, 2015

ConditionsComplex regional pain syndrome type I (CRPS-I)MedDRA version: 18.0Level: LLTClassification code 10064334Term: Complex regional pain syndrome Type ISystem Organ Class: 100000004852 Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

DrugsNerixia 100 mg/8 mL concentrate for solution for infusion

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Complex regional pain syndrome type I (CRPS-I)
Sponsor: Grünenthal GmbH
Enrollment: 225
Status: Active, not recruiting
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

April 7, 2015

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Grünenthal GmbH

Eligibility Criteria

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 renal impairment or a history of chronic kidney disease.
•Serum calcium or magnesium outside of the central laboratory's reference range; history of hypocalcemia; any metabolic disorder anticipated to increase risk for hypocalcemia.
•Vitamin D deficiency. Participants with vitamin D deficiency prior to enrollment may be enrolled with appropriate supplementation during the enrollment period.
•Corrected QT interval greater than 470 milliseconds; treatment with medications within the last 30 days prior to allocation to IMP that have potential to prolong the QT interval or anticipated need for such medications during the course of the trial.
•Any prior use of a bisphosphonate for treatment of CRPS, any prior administration of intravenous bisphosphonate, administration of oral bisphosphonate within the previous year, anticipated requirement for treatment with oral or intravenous bisphosphonate for another condition such as osteoporosis during the trial, or administration of denosumab (Prolia) or other bone turnover suppressing drugs within the past 6 months.
•History of any allergic or hypersensitivity reaction to neridronic acid or other bisphosphonate, or to vitamin D or calcium supplements.
•Recent tooth extraction, unhealed or infected extraction site, or significant dental/periodontal disease that may pre\-dispose to need for tooth extraction or other invasive dental procedures during the trial.