Efficacy and Safety of Intravenous Neridronic Acid in CRPS-I
NCT ID: NCT02402530
Last Updated: 2018-05-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
459 participants
INTERVENTIONAL
2015-04-30
2016-11-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Matching placebo administered as intravenous infusion on Day 1, Day 4, Day 7 and Day 10
Placebo
Matching placebo administered as intravenous infusion.
125 mg Neridronic acid
Neridronic acid 62.5 mg administered as intravenous infusion on Day 1 and Day 4; matching placebo administered as intravenous infusion on Day 7 and Day 10
Placebo
Matching placebo administered as intravenous infusion.
Neridronic acid 62.5 mg
Neridronic acid administered as intravenous infusion.
250 mg Neridronic acid
Neridronic acid 62.5 mg administered as intravenous infusion on Day 1, Day 4, Day 7 and Day 10
Neridronic acid 62.5 mg
Neridronic acid administered as intravenous infusion.
Interventions
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Placebo
Matching placebo administered as intravenous infusion.
Neridronic acid 62.5 mg
Neridronic acid administered as intravenous infusion.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
* Evidence of denture-related gum trauma or improperly fitting dentures causing injury.
* Prior radiation therapy of the head or neck (within 1 year of enrollment).
* Recent treatment with high doses of systemic steroids or anticipated need for concomitant high-dose steroid treatment during the trial.
* History of malignancy within 2 years before enrollment with the exception of basal cell carcinoma.
* Daily intake of long- and short-acting or controlled-release opioid analgesics of more than 200 mg morphine equivalents, regimens combining high-dose opioids and benzodiazepines, or any other treatment regimen considered unstable, unsafe, or have potential to affect the interpretation of the trial.
* Use of nerve blocks, ketamine infusions, intravenous immunoglobulin, acupuncture, electromagnetic field treatment, or initiation/implementation of radiofrequency ablation or other sympathectomy procedures, or peripheral nerve stimulation within 6 weeks prior to allocation to investigational medicinal product.
* Evidence of current alcohol or drug abuse, or history of alcohol or drug abuse within 2 years of enrollment, based on participant history and physical examination and according to the investigator's judgment.
* Any other severe medical condition, including severe depression, or any other severe mood disorder, that in the opinion of the investigator may affect efficacy or safety assessments or may compromise the participant's safety during trial participation.
* Participant is engaged in litigation related to their disability from CRPS in which monetary gain or loss (or other compensation) may affect their objective participation in the trial.
* Women who are pregnant or breastfeeding.
* Elevated aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 2-fold upper limit of normal (ULN), or evidence or history of liver disease.
* Participation in an investigational drug trial within 3 months prior to enrollment, or prior participation in this trial with receipt of any infusion of IMP, even a partial infusion.
18 Years
80 Years
ALL
No
Sponsors
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Grünenthal GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Grünenthal Study Director
Role: STUDY_DIRECTOR
Grünenthal GmbH
Locations
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Site US119 - G & L Research
Foley, Alabama, United States
Site US117 - Valley Pain Consultants
Scottsdale, Arizona, United States
Site US116 - Arizona Pain Specialists
Scottsdale, Arizona, United States
Site US124 - Quality of Life Medical and Research Centers LLC
Tucson, Arizona, United States
Site US154 - Woodland International Research Group
Little Rock, Arkansas, United States
Site US110 - Orange County Research Institute
Anaheim, California, United States
Site US172 - Core Healthcare Group
Cerritos, California, United States
Site US108 - Catalina Research Institute
Chino, California, United States
Site US175 - Inland Pain Medicine
Colton, California, United States
Site US152 - UC San Diego Healthcare Systems, Center for Pain Medicine
La Jolla, California, United States
Site US102 - Samaritan Center for Medical Research
Los Gatos, California, United States
Site US126 - Northern California Research
Sacramento, California, United States
Site US106 - Mountain View Clinical Research
Denver, Colorado, United States
Site US153 - Clinical Research of West Florida Inc - Clearwater
Clearwater, Florida, United States
Site US162 - South Lake Pain Institute
Clermont, Florida, United States
Site US143 - Florida Pain Institute
Merritt Island, Florida, United States
Site US111 - Sunrise Research Institute
Miami, Florida, United States
Site US122 - Precision Research Organization, LLC
Miami Lakes, Florida, United States
Site US104 - Discovery Clinical Trials
Orlando, Florida, United States
Site US133 - Gold Coast Research LLC
Plantation, Florida, United States
Site US171 - Florida Medical Pain Management
St. Petersburg, Florida, United States
Site US121 - Clinical Research of West Florida
Tampa, Florida, United States
Site US165 - Palm Beach Research
West Palm Beach, Florida, United States
Site US131 - Better Health Clinical Research, Inc
Newnan, Georgia, United States
Site US103 - Great Lakes Clinical Trials
Chicago, Illinois, United States
Site US129 - International Clinical Research Institute
Overland Park, Kansas, United States
Site US169 - Massachusetts General Hospital
Boston, Massachusetts, United States
Site US127 - Advance Clinical Research, Inc
St Louis, Missouri, United States
Site US105 - Advanced Biomedical Research of America
Las Vegas, Nevada, United States
Site US101 - Princeton Medical Institute
Princeton, New Jersey, United States
Site US151 - Premier Pain Centers
Shrewsbury, New Jersey, United States
Site US156 - University Clinical Research Center
Somerset, New Jersey, United States
Site US166 - Albany Medical College
Albany, New York, United States
Site US145 - University of Rochester
Rochester, New York, United States
Site US137 - Montefiore Medical Center
The Bronx, New York, United States
Site US135 - The Center for Clinical Research
Winston-Salem, North Carolina, United States
Site US157 - North Star Medical Research
Middleburg Heights, Ohio, United States
Site US149 - Founders Research Corporation
Philadelphia, Pennsylvania, United States
Site US114 - Abington Neurological Associates
Willow Grove, Pennsylvania, United States
Site US112 - Clinical Trials of South Carolina
Charleston, South Carolina, United States
Site US107 - Austin Center for Clinical Research
Austin, Texas, United States
Site US134 - Lovelace Scientific Resources, Inc
Austin, Texas, United States
Site US113 - Pioneer Research Solutions, Inc
Houston, Texas, United States
Site US118 - Omega International Pain Clinic
Salt Lake City, Utah, United States
Site US164 - Advanced Clinical Research
West Jordan, Utah, United States
Site US144 - Bellevue Surgery Center
Bellevue, Washington, United States
Site US173 - Bellevue Surgery Center
Bellevue, Washington, United States
Site US123 - Northwest Clinical Research Center
Bellevue, Washington, United States
Site US161 - Swedish Pain and Headache Center
Seattle, Washington, United States
Site DE107 - Studienzentrum A. Schwittay
Böhlen, , Germany
Site DE104 - Schmerzzentrum Dr. med. C. Wachter & T. Tusker
Fellbach, , Germany
Site DE101 - Klinische Forschung Hannover Mitte GmbH
Hanover, , Germany
Site DE103 - Algesiologikum Studienzentrum und Algesiologikum MVZ
Munich, , Germany
Site DE102 - Universitätsklinikum Würzburg Neurologische Klinik
Würzburg, , Germany
Site GB104 - The Royal Victoria Infirmary
Cambridge, , United Kingdom
Site GB108 - Darlington Memorial Hospital, Centre for Research and clinical Intervention
Darlington, , United Kingdom
Site GB109 - Royal Devon Exeter Hospital
Exeter, , United Kingdom
Site GB101 - Guys and St. Thomas NHS Foundation Trust - St Thomas Hospital
London, , United Kingdom
Site GB111 - Chelsea and Westminster Hospital - NHS Foundation Trust
London, , United Kingdom
Countries
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Other Identifiers
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U1111-1151-2181
Identifier Type: OTHER
Identifier Source: secondary_id
2014-001915-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
KF7013-01
Identifier Type: -
Identifier Source: org_study_id
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