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NCT03530345 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Intravenous Neridronic Acid in CRPS
A Phase 3 study, sponsored by Grünenthal.
- Terminated
- Registry status
- Phase 3
- Development phase
- 182
- Enrollment target
NCT03530345 is a Phase 3 study that was terminated before completion, run by Grünenthal. The registered enrollment target is 182 participants.
The verdict
NCT03530345, a Phase 3 study, was terminated before completion, sponsored by Grünenthal.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 182 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 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.
Interventions
- DRUG Placebo
- DRUG Neridronic acid 100 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 182 participants |
| Start Date | 2018-05-30 |
| Est. Completion | 2019-07-31 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03530345
The ClinicalTrials.gov registry entry for NCT03530345 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 182 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.
NCT03530345 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03530345 about?
NCT03530345 is a clinical study titled "Efficacy and Safety of Intravenous Neridronic Acid in 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 1...
What is the current status of trial NCT03530345?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 182 participants. The study started on 2018-05-30. Estimated completion is 2019-07-31.
What interventions are being tested in trial NCT03530345?
The interventions under investigation include: Placebo (DRUG), Neridronic acid 100 mg (DRUG).
Who is sponsoring clinical trial NCT03530345?
This trial is sponsored by Grünenthal, which has 16 total clinical trials registered on ClinicalTrials.gov.
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