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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: Clinical Trial Phase 3 study, sponsored by Grünenthal.
NCT03530345 is a Phase 3 study that was terminated before completion, run by Grünenthal. The registered enrollment target is 182 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (76% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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.
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 |
Why NCT03530345 stopped before completion
NCT03530345 is an interventional study that assigns participants to a tested intervention. The registered 182 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (76% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03530345 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03530345's enrollment target sits among peer trials
182 1421st of 2000 higher than 579 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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