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Complex Regional Pain Syndrome (CRPS)Phase 3NCT03530345

Efficacy and Safety of Intravenous Neridronic Acid in CRPS

A Phase 3 study testing Neridronic acid 100 mg in people with Complex Regional Pain Syndrome (CRPS), run by Grünenthal GmbH at 71 sites in 7 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Complex Regional Pain Syndrome (CRPS)
What is being tested?
Neridronic acid 100 mg
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
182 participants
Where
71 sitesin 7 countries
Study dates
30 May 2018to 31 Jul 2019
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Informed consent signed.
  • Male or female participant at least 18 years of age at Visit 1.
  • A diagnosis of CRPS according to the clinical diagnostic criteria recommended by the International Association for the Study of Pain (IASP; "Budapest clinical criteria"), assessed at Visit 1. Signs and symptoms of CRPS must apply to an affected limb (arm or leg) and must demonstrate asymmetry with respect to the contralateral limb. The CRPS duration must be 2 years or less since onset of symptoms.
  • A baseline average pain intensity score of greater than or equal to 4 using an 11-point numerical rating scale (NRS), referring to the CRPS-affected limb (average of pain recorded over 7 days). The baseline average pain intensity score will be calculated automatically by the electronic diary, which must be checked prior to allocation at Visit 2. A participant who has not met average baseline pain intensity requirements (at least 4 average pain intensity ratings) due to lack of compliance with the electronic diary may be rescheduled for Visit 2 (1 time only), with appropriate re-training to ensure compliance with use of the electronic diary.
  • In stable treatment and follow-up therapy for CRPS for at least 1 month prior to allocation to treatment (Visit 2). Participants must have failed attempts with at least 2 available treatments for CRPS, 1 of which must have been a pharmacologic treatment.
  • Women of child-bearing potential must have a negative urine Beta-human chorionic gonadotropin (ß-HCG) pregnancy test at Visit 1 and must be using 2 forms of medically acceptable contraception, including at least 1 highly effective method of contraception with a low failure rate, defined as less than 1% per year, and a second medically acceptable method such as use of condoms with spermicide by their male partner. A barrier method alone is not acceptable. Highly effective methods of contraception must be used for at least 1 month prior to Visit 2 and for the duration of 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 (assistance in filling out the questionnaires may be provided, if required due to motor or other physical impairment).

Who cannot join

  • Evidence of severe renal impairment (estimated Glomerular Filtration Rate [eGFR] less than 30 mL/min/1.73 m2 using the 2009 Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] creatinine equation [Levey et al. 2009] or a urinary albumin to creatinine ratio [ACR] greater than 150 mg/g), based on central safety laboratory data obtained prior to Visit 2. Note: a single repeat laboratory test is allowed.
  • Serum calcium or magnesium outside of the central laboratory's reference range, based on central safety laboratory data obtained prior to Visit 2 (2 repeat laboratory tests are allowed); a history of hypocalcemia or a metabolic disorder anticipated to increase risk for hypocalcemia (e.g., hypoparathyroidism); anticipated need for any new drug with known potential to cause hypocalcemia (e.g., aminoglycosides, new treatment with or dose adjustment of loop diuretics) during the trial. Participants on a stable dose of loop diuretics may receive treatment with IMP as long as no dosage increases in the diuretic medication are anticipated and calcium levels are in the reference range.
  • Vitamin D deficiency, defined as a 25(OH)D level less than 30 ng/mL (75 nmol/L), based on central safety laboratory data obtained prior to Visit 2 (up to 4 repeat laboratory tests are allowed). Participants with vitamin D deficiency should receive appropriate supplementation during the Enrollment Period. A vitamin D level of at least 30 ng/mL (75 nmol/L) must be documented prior to allocation to IMP.
  • Corrected QT interval (according to Fridericia's formula; QTcF) greater than 470 ms (average of 3 Electrocardiogram (ECGs) obtained at Visit 1) according to central ECG reading facility evaluation or QTcF greater than 470 ms at pre-dose ECG at Visit 2 according to the investigator's judgment; serum potassium outside the central laboratory's reference range at Visit 1(a single repeat laboratory test is allowed); clinically unstable cardiac disease, including: unstable atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, active myocardial ischemia, or an indwelling pacemaker; evidence of complete left bundle branch block; complete atrioventricular block; history of Long QT Syndrome or a relative with this condition; or any history of or other known risk factor for torsade de pointes.
  • Participants receiving medications with a known risk of torsades de pointes within 7 days prior to allocation. Participants receiving selective serotonin re-uptake inhibitor antidepressants (e.g., citalopram, escitalopram) are eligible if the QT interval values do not meet the exclusion criteria, the medication was started at least 1 month prior to Visit 1, the dose is stable, and the dose is anticipated to remain stable throughout the trial.
  • Any prior use of a bisphosphonate for treatment of CRPS, any prior administration of a bisphosphonate within the previous year, anticipated requirement for treatment with a bisphosphonate for another condition such as osteoporosis during the trial, or administration of denosumab (Prolia®) or other bone turnover suppressing drugs within 6 months prior to Visit 1.
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  • History of any allergic or hypersensitivity reaction to neridronic acid or other bisphosphonate, acetaminophen, or to vitamin D or calcium supplements.
  • Recent tooth extraction or other invasive dental procedure (within 3 months prior to Visit 1), 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. Participants with indeterminate, suspicious or unreliable dental history, in the opinion of the investigator, must undergo a dental examination prior to receiving treatment.
  • Evidence of denture-related gum trauma or improperly fitting dentures causing injury.
  • Prior radiation therapy of the head or neck (within 1 year of Visit 1).
  • History of malignancy within 2 years prior to Visit 1, with the exception of basal cell carcinoma.
  • 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 Visit 1.
  • Evidence of current alcohol or drug abuse, or history of alcohol or drug abuse within 2 years of Visit 1, 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 participants safety during trial participation.
  • Women who are pregnant or breastfeeding.
  • Elevated aspartate aminotransferase or alanine aminotransferase greater than 2-fold upper limit of normal, based on central safety laboratory data obtained at Visit 1, or current evidence of chronic liver disease. Safety laboratory testing may be repeated prior to Visit 2, and participants will be allowed in the trial if results of 2 consecutive tests, at least 3 days apart, are less than or equal to 2-fold upper limit of normal.
  • Participation in another investigational drug trial within 3 months prior to Visit 1, or any previous trial involving neridronic acid.
  • 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.
  • Participants taking forbidden concomitant medications/therapies or not being able to follow the rules of use of concomitant treatment.
  • Participants incapable of giving informed consent.
  • Criteria to continue into Treatment Period B
  • A value of at least 4 on the pain intensity question (question number 29, GLOBAL07) of the Patient-Reported Outcomes Measurement Information System (PROMIS®) (PROMIS-29 profile) at Visit 11.
  • The following exclusion criteria are not met:
  • Evidence of severe renal impairment (eGFR less than 30 mL/min/1.73 m2 using the 2009 CKD-EPI creatinine equation [Levey et al. 2009] or a urinary ACR greater than 150 mg/g), based on central safety laboratory data obtained prior to Visit 11. A single repeat laboratory test is allowed.
  • Corrected QT interval (QTcF) greater than 470 ms (average of 3 ECGs obtained at Visit 10) according to the central ECG reading facility evaluation or QTcF greater than 470 ms at pre-dose ECG at Visit 11 according to the investigator's judgment; serum potassium outside the central laboratory's reference range at Visit 10 (a single repeat laboratory test is allowed); clinically unstable cardiac disease, including: unstable atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, active myocardial ischemia, or an indwelling pacemaker; evidence of complete left bundle branch block; complete atrioventricular block; any other known risk factor for torsade de pointes.
  • Participants receiving medications with a known risk of torsades de pointes within 7 days prior to re-allocation.
  • Participants taking forbidden concomitant medications/therapies or not being able to follow the rules of use of concomitant treatment.
  • Recent tooth extraction or other invasive dental procedure (within 3 months prior to Visit 11), 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 further course of the trial.
  • Serum calcium or magnesium outside of the central laboratory's reference range, despite appropriate supplementation between Visit 10 and Visit 11, based on the last central safety laboratory data obtained prior to Visit 11. One repeat laboratory test is allowed.
  • Vitamin D deficiency prior to IMP re-allocation, defined as a 25(OH)D level less than 30 ng/mL (75 nmol/L), based on the last central safety laboratory data obtained prior to Visit 11, i.e., inability to normalize 25(OH)D levels to at least 30 ng/mL (75 nmol/L) despite appropriate supplementation between Visit 10 and Visit 11. Two repeat laboratory tests are allowed (with a minimum interval of 3 days).
  • Elevated aspartate aminotransferase or alanine aminotransferase greater than 2-fold upper limit of normal, based on central safety laboratory data obtained at Visit 10, or current evidence of chronic liver disease. A single repeat laboratory test is allowed.
  • No other criterion for trial and/or IMP discontinuation is met.

Trial locations and contacts

71 sites in 7 countries.

71 sites in 7 countries

United States39 sites

  • US029 - Dent Neurologic Institute

    Amherst, New York, 14226

  • US049 - Orange County Research Institute

    Anaheim, California, 92801

  • US032 - Millennium Pain Center

    Bloomington, Illinois, 61704

  • US007 - Neurology Offices of South Florida

    Boca Raton, Florida, 33428

  • US053 - Core Healthcare Group

    Cerritos, California, 90703

  • US022 - The Neurological Institute

    Charlotte, North Carolina, 28204

  • US033 - Galen Research

    Chesterfield, Missouri, 63005

  • US013 - Inland Pain Medicine

    Colton, California, 92324

  • US005 - Hometown Urgent Care and Research

    Dayton, Ohio, 45424

  • US011 - Otrimed Corporation

    Edgewood, Kentucky, 41017

  • Us054 - Aa Mrc

    Flint, Michigan, 48504

  • US030 - Gulfcoast Clinical Research Center

    Fort Myers, Florida, 33912

  • US036 - Denver Back Pain Specialists

    Greenwood Village, Colorado, 80111

  • US003 - HealthStar Research

    Hot Springs, Arkansas, 71913

  • US055 - Diversified Medical Practices

    Houston, Texas, 77057

  • US015 - Tennessee Valley Pain Consultants

    Huntsville, Alabama, 35801

  • US009 - Elite Clinical Research

    Jackson, Mississippi, 39202

  • US017 - Jackson Anesthesia Pain Center

    Jackson, Mississippi, 39202

  • US004 - The Chappel Group Research

    Kissimmee, Florida, 34744

  • US044 - The Helm Center for Pain Management

    Laguna Woods, California, 92637

  • US023 - AGR Research

    Lake Worth, Florida, 33462

  • US027 - Drug Studies America

    Marietta, Georgia, 30060

  • US043 - Horizon Research Partners

    Mobile, Alabama, 36605

  • US041 - Better Health Clinical Research, Inc.

    Newnan, Georgia, 30265

  • US040 - Regeneris Medical

    North Attleboro, Massachusetts, 02760

  • US038 - DiGiovanna Institute For Medical Education

    North Massapequa, New York, 11758

  • US020 - SIMEDHealth

    Ocala, Florida, 34474

  • US021 - SP Research PLLC

    Oklahoma City, Oklahoma, 73112

  • US012 - NeuroMedical Research Center

    Panama City, Florida, 32405

  • US045 - Holland Center for Family Health

    Peoria, Arizona, 85381

  • US028 - Founders Research Corporation

    Philadelphia, Pennsylvania, 19152

  • US037 - Clinical Research Partners

    Richmond, Virginia, 23235

  • US048 - Axios Research

    Salt Lake City, Utah, 84106

  • US050 - Premier Pain Centers

    Shrewsbury, New Jersey, 07702

  • US018 - Carolinas Center for Advanced Management of Pain

    Spartanburg, South Carolina, 29303

  • US046 - Clinical Research of West Florida, Inc.

    Tampa, Florida, 33603

  • US025 - Oakland Medical Research

    Troy, Michigan, 48085

  • US052 - Providere' Research Inc.

    West Covina, California, 91790

  • US047 - The Center for Clinical Research

    Winston-Salem, North Carolina, 27103

Other trials in United States

South Korea8 sites

  • KR008 - Chungnam National University Hospital

    Daejeon, 35015

  • KR003 - Seoul National University Bundang Hospital

    Seongnam-si, 13620

  • KR002 - Seoul National University Hospital

    Seoul, 03080

  • KR005 - Samsung Medical Center

    Seoul, 06351

  • KR007 - Konkuk University Medical Center

    Seoul, 5030

  • KR004 - Seoul St Mary's Hospital

    Seoul, 6591

  • KR006 - Korea University Guro Hospital

    Seoul, 8308

  • KR001 - Ajou University Medical Center

    Suwon, 16499

Other trials in South Korea

Germany7 sites

  • DE006 - Center for Clinical Research Dr. med. I. Schoel

    Bad Homburg, 61348

  • DE011 - Klinische Forschung Berlin Mitte GmbH

    Berlin, 10117

  • DE009 - BAG Anästhesie, Schmerztherapie, Palliativmedizin

    Cottbus, 03046

  • DE002 - Klinische Forschung Hamburg GmbH

    Hamburg, 20253

  • DE010 - Klinische Forschung Hannover Mitte

    Hanover, 30159

  • DE013 - Klinik und Poliklinik für Neurologie Universitätsmedizin Mainz

    Mainz, 55131

  • DE005 - Klinische Forschung Schwerin GmbH

    Schwerin, 19055

Other trials in Germany

Spain7 sites

  • ES009 - General Hospital of Alicante

    Alicante, 03010

  • ES002 - Hospital de la Santa Creu i Sant Pau

    Barcelona, 08041

  • ES005 - Hospital Sanitas La Moraleja Pain Unit

    Madrid, 28050

  • ES004 - Hospital Universitario Puerto Real Unidad de Anestesiologia

    Puerto Real, 11510

  • ES006 - Hospital Infanta Luisa Rheumatology

    Seville, 41010

  • ES007 - Hospital Clínico Universitario de Valencia

    Valencia, 46010

  • ES008 - Hospital Lluis Alcanyis Anesthesiology and Pain Unit

    Xàtiva, 46800

Other trials in Spain

Australia4 sites

  • AU003 - Neuro Trials Victoria Pty Ltd

    Noble Park, Victoria, 3174

  • AU001 - The Avenue Cardiovascular Centre Level 1 Masada Private Hospital

    St Kilda East, Victoria, 3183

  • AU002 - Royal North Shore Hospital Michael J Cousins Pain Management and Research Centre

    St Leonards, New South Wales, 2065

  • AU005 - Port Kembla Public Hospital

    Wollongong, New South Wales, 2502

Other trials in Australia

France3 sites

  • FR004 - Centre Hospitalier Universitaire Amiens Picardie

    Amiens, 80054

  • FR001 - Centre Hospitalier Universitaire Grenoble Alpes Centre de la douleur

    Grenoble, 38043

  • FR002 - L'Hôpital Privé du Confluent Département d'évaluation et traitement de la douleur

    Nantes, 44277

Other trials in France

New Zealand3 sites

  • NZ002 - Southern Clinical Trials Group Ltd

    Christchurch, Canterbury, 8013

  • NZ004 - Optimal Clinical Trials

    Grafton, Auckland, 1010

  • Nz001 - Bay of Plenty Clinical Trials Unit, Bay of Plenty District Health Board

    Tauranga, Bay of Plenty, 3112

Other trials in New Zealand

About this study

Official title: Randomized, Double-blind, Placebo-controlled Trial Investigating the Efficacy and Safety of Intravenous Neridronic Acid in Subjects With Complex Regional Pain Syndrome (CRPS)

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.

Being tested
Neridronic acid 100 mg, Placebo
Keywords
Neridronic Acid, Neridronate, CRPS, reflex sympathetic dystrophy (RSD)
Medical subject headings
Complex Regional Pain Syndromes, Reflex Sympathetic Dystrophy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Neridronic acid 100 mgDrug

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

  • PlaceboDrug

    Glass vials with matching placebo.

Study groups in NCT03530345
Study groupRoleWhat they receive
Neridronic acidExperimentalNeridronic acid 100 mg - 4 intravenous (i.v.) infusions within 10 days (i.e., on Days 1, 4, 7, and 10). The investigational medicinal product (IMP) was diluted in sterile normal saline to a volume of approximately 500 mL before slow administration. The maximum neridronic acid dose was 800 mg: 400 mg in Treatment Period A and 400 mg in Treatment Period B.
Receives: Drug: Neridronic acid 100 mg
PlaceboPlacebo comparatorMatching placebo - 4 intravenous infusions within 10 days (i.e., on Days 1, 4, 7, and 10). The IMP was diluted in sterile normal saline to a volume of approximately 500 mL before slow administration.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline to Week 12 in the Average Pain Intensity Score (Weekly Average of Pain Values Recorded Daily in the Electronic Diary)

    In the Baseline Phase and in Treatment Period A/Follow-up Period 1, participants were asked to assessed their average CRPS-related pain on an 11-point numerical rating scale (NRS) - from 0 = "no pain" to 10 = "pain as bad as you can imagine" and report it once daily (in the evening, 24-hour recall) in an electronic diary.

    Changes from baseline (average for the Baseline Phase) to the weekly average for Week 12 were calculated.

    Measured: From the Baseline Phase (Day -7 to Day -1) to Week 12

Secondary outcomes (6)

  1. Change From Baseline to Week 26 in the Average Pain Intensity Recorded on the Tablet Computer.

    11-point NRS - from 0 = "no pain" to 10 = "pain as bad as you can imagine" - reported at the visits on a tablet computer (24-hour recall). Changes from baseline to Week 26 were planned to be analyzed.

    Measured: From baseline (Visit 2 [Day 1]) to Visit 11 (Week 26)

  2. Pain Response to Treatment, Defined as at Least 30% Decrease From Baseline in the Average Pain Intensity at Week 12, Recorded on the Tablet Computer.

    11-point NRS - from 0 = "no pain" to 10 = "pain as bad as you can imagine" - reported at the visits on a tablet computer (24-hour recall). The number of participants with response at Week 12 was planned to be determined.

    Measured: From baseline (Visit 2 [Day 1]) to Visit 8 (Week 12)

  3. Pain Response to Treatment, Defined as at Least 30% Decrease From Baseline in the Average Pain Intensity at Week 26, Recorded on the Tablet Computer.

    11-point NRS - from 0 = "no pain" to 10 = "pain as bad as you can imagine" - reported at the visits on a tablet computer (24-hour recall). The number of participants with response at Week 26 was planned to be determined.

    Measured: From baseline (Visit 2 [Day 1]) to Visit 11 (Week 26)

  4. Change From Baseline to Week 12 in the Pain Intensity Level of Dynamic Mechanical Allodynia (DMA).

    Dynamic mechanical allodynia: a tactile stimulus is applied in a single sweeping motion (1 cm to 2 cm length) on the skin on the affected limb. The participants are asked to judge the stimulus intensity by means of an NRS (0 to 10). "0" in this case means "no pain". Each "pricking", "stinging" or "burning" sensation is defined as a painful sensation, which should always be evaluated by giving a value greater than "0". "10" corresponds to the individual maximum pain imaginable. Change from baseline was planned to analyzed.

    Measured: From baseline (Visit 2 [Day 1]) to Visit 8 (Week 12)

  5. Change From Baseline to Week 12 in the Pressure Pain Threshold (PPT) Ratio for the Thenar Muscle/Abductor Hallucis Muscle.

    Pressure pain threshold: using a pressure algometer (contact area 1 cm2), the threshold for pressure-induced pain is measured on the thenar muscle/abductor hallucis muscle in 3 series of slowly increasing stimulus intensities (at a rate of about 50 kPa/s). The threshold is then determined as the arithmetic mean of the 3 series (in kPa).

    The ratio of the thresholds of the affected limb versus the unaffected limb was planned to be calculated.

    Measured: From baseline (Visit 2 [Day 1]) to Visit 8 (Week 12)

  6. Change From Baseline to Week 12 in the Ratio of the Figure of Eight Measurements of the Affected Limb Versus the Unaffected Limb.

    In participants with the CRPS sign of edema on the CRPS severity score at baseline, circumference of the hand or foot will be measured by the investigator with measurement tape using the figure-of-eight method at both the affected limb and the contralateral unaffected limb. Each measurement will be performed 3 times. The average of the 3 measurements will be used for further analysis.

    The ratio of the averages of the affected limb versus the unaffected limb was planned to be calculated and used for the determination of the change from baseline.

    Measured: From baseline (Visit 2 [Day 1]) to Visit 8 (Week 12)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 May 2018
  2. Study start30 May 2018
  3. Primary completion31 Jul 2019
  4. Study completion31 Jul 2019

Why it stopped: Sponsor decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
182 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03530345
Sponsor's protocol ID
KF7013-02
Other IDs
2016-003833-91, U1111-1187-8036, 2016
Status last verified
Jul 2020
First submitted
7 May 2018
Last updated
6 Aug 2020
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Information available on the Grünenthal Group Web Site (see URL below for details); according to the European Federation of Pharmaceutical Industries and Associations (EFPIA) Data Sharing Principles.

Publications

  • Levey AS, Stevens LA, Schmid CH, Zhang YL, Castro AF 3rd, Feldman HI, Kusek JW, Eggers P, Van Lente F, Greene T, Coresh J; CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration). A new equation to estimate glomerular filtration rate. Ann Intern Med. 2009 May 5;150(9):604-12. doi: 10.7326/0003-4819-150-9-200905050-00006.

    PubMed 19414839

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Neridronic acid 100 mg in people with Complex Regional Pain Syndrome (CRPS), run by Grünenthal GmbH at 71 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 6 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 71 sites in United States, South Korea, Germany, Spain, Australia and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline to Week 12 in the Average Pain Intensity Score (Weekly Average of Pain Values Recorded Daily in the Electronic Diary) (time frame: From the Baseline Phase (Day -7 to Day -1) to Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03530345, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2020.

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