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NCT03304379 · ClinicalTrials.gov registry record · Phase 3
Study to Determine the Safety and the Efficacy of Fasinumab Compared to Placebo and Nonsteroidal Anti-inflammatory Drugs (NSAIDs) for Treatment of Adults With Pain From Osteoarthritis of the Knee or Hip
A Phase 3 study of Osteoarthritis, Knee and Osteoarthritis, Hip, sponsored by Regeneron Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,650
- Enrollment target
- 20
- Study locations
NCT03304379 is a Phase 3 study of Osteoarthritis, Knee and Osteoarthritis, Hip that has completed, run by Regeneron Pharmaceuticals. The registered enrollment target is 1,650 participants, above the 562-participant average among 91 other Osteoarthritis, Knee trials with a reported enrollment target (194% higher). The trial reports 20 study locations across 5 states.
The verdict
NCT03304379, a Phase 3 study of Osteoarthritis, Knee and Osteoarthritis, Hip, has completed, sponsored by Regeneron Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,650 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary objective of the study is to evaluate the efficacy of fasinumab compared to placebo, when administered for up to 24 weeks in patients with pain due to osteoarthritis (OA) of the knee or hip. The secondary objectives of the study are: * To evaluate the efficacy of fasinumab compared to non-steroidal anti-inflammatory drugs (NSAID)s, when administered for up to 24 weeks in patients with pain due to OA of the knee or hip * To assess the safety and tolerability of fasinumab compared to placebo and compared to NSAIDs, when administered for up to 24 weeks in patients with pain due to OA of the knee or hip
Conditions Studied
Interventions
- DRUG Matching placebo
- DRUG Fasinumab
- OTHER Diclofenac
- OTHER Celecoxib
Study Locations (20)
California
- Advance Research Center - Anaheim
- TriWest Research Associates, LLC - El Cajon
- Paragon Rx Clinical Research, Inc. - Garden Grove
- Catalina Research Institute, LLC - Montclair
- Sierra Clinical Research - Roseville
- UC Davis Center for Musculoskeletal Health - Sacramento
- Advanced Research Center, Inc - San Diego
- California Research Foundation - San Diego
- Paragon Rx Clinical Research, Inc - Santa Ana
- Encompass Clinical Research - Spring Valley
- Westlake Medical Research - Thousand Oaks
- Synexus Clinical Research US, Inc. - Vista
Arizona
- Clinical Research Advantage, Inc./Warner Family Practice, PC - Chandler
- Synexus Central Phoenix Medical Clinic - Phoenix
- Clinical Research Consortium Arizona - Tempe
Alabama
- Pinnacle Research Group, Llc - Anniston
- Horizon Research Partners - Mobile
Connecticut
- New England Research Associates, LLC - Bridgeport
- CRM of Greater New Haven, LLC - Hamden
Colorado
- Mountain View Clinical Research - Denver
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,650 participants |
| Start Date | 2017-10-26 |
| Est. Completion | 2020-11-09 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03304379
The ClinicalTrials.gov registry entry for NCT03304379 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,650 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 562-participant average among 91 other Osteoarthritis, Knee trials with a reported enrollment target (194% higher). The listed sponsor is Regeneron Pharmaceuticals, which has 280 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Osteoarthritis, Knee appearing as the primary indexed condition, and to 4 interventions - of which Matching placebo is the first listed.
NCT03304379 reports 20 study locations spanning 5 distinct geographic areas - top geographies include California, Arizona, Alabama.
Frequently Asked Questions
What is clinical trial NCT03304379 about?
NCT03304379 is a clinical study titled "Study to Determine the Safety and the Efficacy of Fasinumab Compared to Placebo and Nonsteroidal Anti-inflammatory Drugs (NSAIDs) for Treatment of Adults With Pain From Osteoarthritis of the Knee or Hip". The primary objective of the study is to evaluate the efficacy of fasinumab compared to placebo, when administered for up to 24 weeks in patients with pain due to osteoarthritis (OA) of the knee or hip. The secondary objectives of the study are: * To evaluate the efficacy of fasinumab compared to ...
What is the current status of trial NCT03304379?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,650 participants. The study started on 2017-10-26. Estimated completion is 2020-11-09.
What conditions does trial NCT03304379 study?
This clinical trial studies the following conditions: Osteoarthritis, Knee, Osteoarthritis, Hip.
What interventions are being tested in trial NCT03304379?
The interventions under investigation include: Matching placebo (DRUG), Fasinumab (DRUG), Diclofenac (OTHER), Celecoxib (OTHER).
Who is sponsoring clinical trial NCT03304379?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03304379 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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