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NCT02972359 · ClinicalTrials.gov registry record · Phase 3
Safety of Intravenous Neridronic Acid in CRPS
A Phase 3 study of Complex Regional Pain Syndrome, sponsored by Grünenthal.
- Completed
- Registry status
- Phase 3
- Development phase
- 580
- Enrollment target
- 20
- Study locations
NCT02972359: Completed Phase 3 study of Complex Regional Pain Syndrome, sponsored by Grünenthal.
NCT02972359 is a Phase 3 study of Complex Regional Pain Syndrome that has completed, run by Grünenthal. The registered enrollment target is 580 participants, above the 78-participant average among 3 other Complex Regional Pain Syndrome trials with a reported enrollment target (644% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02972359, a Phase 3 study of Complex Regional Pain Syndrome, has completed, sponsored by Grünenthal.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 580 participants
- Enrollment target
- 20
- Study locations
Study Summary
The aim of this trial was to investigate the safety of intravenous neridronic acid in patients with complex regional pain syndrome (CRPS). The trial was divided into 3 periods: a 60-day enrollment period, a treatment period consisting of 4 infusions over 10 days, and a follow-up period of approximately 50 weeks (with visits at Week 2, Week 6, Week 12, Week 26, Week 39, and Week 52).
Primary Outcome
The primary endpoint of this trial was a binary endpoint assessing whether or not a participant experienced any TEAE.
Conditions Studied
Interventions
- DRUG Neridronic acid
Study Locations (20)
California
- US012: Orange County Research Institute - Anaheim
- US022: Core Healthcare Group - Cerritos
- US033: Alliance Research Centers - Laguna Hills
- US027: The Helm Center for Pain Management - Laguna Woods
- US003: Samaritan Center for Medical Research - Los Gatos
- US010: Catalina Research Institute, LLC - Montclair
- US014: Northern California Research - Sacramento
Florida
- US032: South Lake Pain Institute - Clermont
- US001: Sunrise Research Institute, Inc - Miami
- US046: AMPM Research Clinic - Miami
- US035: Compass Research - Orlando
- US031: Gold Coast Research, LLC - Plantation
- US011: Clinical Research of West Florida, Inc. - Tampa
- US040: Palm Beach Research Center - West Palm Beach
Arizona
- US017: Cactus Clinical Research, Inc. - Phoenix
- US028: Quality of Life Medical and Research Centers LLC - Tucson
Arkansas
- US045: Woodland International Research Group - Little Rock
- US044: Woodland Research Northwest - Rogers
Colorado
- US034: Mountain View Clinical Research, Inc. - Denver
Georgia
- US026: Better Health Clinical Research Inc. - Newnan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 580 participants |
| Start Date | 2016-12-20 |
| Est. Completion | 2019-01-09 |
| Phase | Phase 3 |
What the finished NCT02972359 record still lists
NCT02972359 is an interventional study that assigns participants to a tested intervention. The registered 580 participants enrollment target is mid-sized for trials with a published cap, above the 78-participant average among 3 other Complex Regional Pain Syndrome trials with a reported enrollment target (644% higher).
The record links to 1 condition, with Complex Regional Pain Syndrome appearing as the primary indexed condition, and to 1 intervention - of which Neridronic acid is the first listed.
NCT02972359 names 20 study sites across 6 states, led by California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT02972359 about?
NCT02972359 is a clinical study titled "Safety of Intravenous Neridronic Acid in CRPS". The aim of this trial was to investigate the safety of intravenous neridronic acid in patients with complex regional pain syndrome (CRPS). The trial was divided into 3 periods: a 60-day enrollment period, a treatment period consisting of 4 infusions over 10 days, and a follow-up period of approxima...
What is the current status of trial NCT02972359?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 580 participants. The study started on 2016-12-20. Estimated completion is 2019-01-09.
What conditions does trial NCT02972359 study?
This clinical trial studies the following conditions: Complex Regional Pain Syndrome.
What interventions are being tested in trial NCT02972359?
The interventions under investigation include: Neridronic acid (DRUG).
Who is sponsoring clinical trial NCT02972359?
This trial is sponsored by Grünenthal, which has 16 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02972359 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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