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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: Completed Phase 3 study of Osteoarthritis, Knee and Osteoarthritis, Hip, sponsored by Regeneron Pharmaceuticals.
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 483-participant average among 112 other Osteoarthritis, Knee trials with a reported enrollment target (242% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index joint (knee or hip) in past 48 hours. It was calculated as the mean of the scores from the 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (higher pain), where higher scores indicated higher pain.
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 |
What the finished NCT03304379 record still lists
NCT03304379 is an interventional study that assigns participants to a tested intervention. Its 1,650 participants enrollment target places it among the larger protocols in the corpus, above the 483-participant average among 112 other Osteoarthritis, Knee trials with a reported enrollment target (242% higher).
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 names 20 study sites across 5 states, led by 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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03304379's enrollment target sits among peer trials
1,650 6th of 112 higher than 107 of 112 other Osteoarthritis, Knee trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Osteoarthritis, Knee 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.
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