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NCT03560986 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Intravenous Neridronic Acid in Complex Regional Pain Syndrome (CRPS)
A Phase 3 study, sponsored by Grünenthal.
- Terminated
- Registry status
- Phase 3
- Development phase
- 267
- Enrollment target
NCT03560986 is a Phase 3 study that was terminated before completion, run by Grünenthal. The registered enrollment target is 267 participants.
The verdict
NCT03560986, a Phase 3 study, was terminated before completion, sponsored by Grünenthal.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 267 participants
- Enrollment target
Study 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 100 mg or placebo) over 10 days, and a Follow-up Period 1 until Week 26. At Week 26, 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. Participants not meeting the pre-specified criteria to continue into Treatment Period B continued in Follow-up Period 2 until Week 52.
Interventions
- DRUG Placebo
- DRUG Neridronic acid 100 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 267 participants |
| Start Date | 2018-05-31 |
| Est. Completion | 2019-08-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03560986
The ClinicalTrials.gov registry entry for NCT03560986 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 267 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Grünenthal, which has 16 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03560986 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03560986 about?
NCT03560986 is a clinical study titled "Efficacy and Safety of Intravenous Neridronic Acid in 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 100 mg or placebo)...
What is the current status of trial NCT03560986?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 267 participants. The study started on 2018-05-31. Estimated completion is 2019-08-01.
What interventions are being tested in trial NCT03560986?
The interventions under investigation include: Placebo (DRUG), Neridronic acid 100 mg (DRUG).
Who is sponsoring clinical trial NCT03560986?
This trial is sponsored by Grünenthal, which has 16 total clinical trials registered on ClinicalTrials.gov.
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