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NCT01451385 · ClinicalTrials.gov registry record · Phase 3
Study of COV795 in Subjects With Osteoarthritis or Chronic Low Back Pain
A Phase 3 study of Osteoarthritis and Low Back Pain, sponsored by Mallinckrodt.
- Completed
- Registry status
- Phase 3
- Development phase
- 376
- Enrollment target
- 20
- Study locations
NCT01451385: Completed Phase 3 study of Osteoarthritis and Low Back Pain, sponsored by Mallinckrodt.
NCT01451385 is a Phase 3 study of Osteoarthritis and Low Back Pain that has completed, run by Mallinckrodt. The registered enrollment target is 376 participants, below the 815-participant average among 135 other Osteoarthritis trials with a reported enrollment target (54% lower). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01451385, a Phase 3 study of Osteoarthritis and Low Back Pain, has completed, sponsored by Mallinckrodt.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 376 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary objective is to demonstrate the safety and tolerability of COV795 with up to 35 days use as evaluated by physical exam, vital signs, pulse oximetry, clinical laboratory tests, and other adverse events (AEs).
Primary Outcome
Collection of AEs began with subject's signing of the informed consent form, continued throughout the trial, and ended 7 days following the last dose of study drug, or at early termination. Treatment emergent AEs (TEAEs) are AEs that occurred after the first dose of study drug. TEAEs leading to discontinuation include 2 subjects who died (deaths not related to study drug). Clinically significant changes in values from physical exam, vital signs, clinical laboratory tests, and pulse oximetry were
Conditions Studied
Interventions
- DRUG COV795
Study Locations (20)
Florida
- Orthopedic Research Institute - Boynton Beach
- Avail Clinical Research - DeLand
- Eastern Research - Hialeah
- Scientific Clinical Research, Inc. - North Miami
- Clinical Neuroscience Solutions, Inc. - Orlando
- Compass Research, LLC - Orlando
- Compass Research East, LLC - Oviedo
- Gold Coast Research LLC - Plantation
- Accord Clinical Research, LLC - Port Orange
- Sarasota Pain Medicine Research, LLC - Sarasota
California
- Advanced Clinical Research Institute - Anaheim
- Orange County Research Institute - Anaheim
- United Clinical Research Center, Inc. - Anaheim
- Associated Pharmaceutical Research Center, Inc. - Buena Park
- Catalina Research Institute, LLC - Chino
- Synergy Escondido Clinical Research - Escondido
- Convergys Clinical Research, Inc. - Fresno
- Triwest Research Associates - La Mesa
- Skyline Research, Inc. - Long Beach
Arizona
- Genova Clinical Research - Tucson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 376 participants |
| Start Date | 2011-09-20 |
| Est. Completion | 2012-06-18 |
| Phase | Phase 3 |
What the finished NCT01451385 record still lists
NCT01451385 is an interventional study that assigns participants to a tested intervention. The registered 376 participants enrollment target is mid-sized for trials with a published cap, below the 815-participant average among 135 other Osteoarthritis trials with a reported enrollment target (54% lower).
The record links to 2 conditions, with Osteoarthritis appearing as the primary indexed condition, and to 1 intervention - of which COV795 is the first listed.
NCT01451385 names 20 study sites across 3 states, led by Florida, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT01451385 about?
NCT01451385 is a clinical study titled "Study of COV795 in Subjects With Osteoarthritis or Chronic Low Back Pain". The primary objective is to demonstrate the safety and tolerability of COV795 with up to 35 days use as evaluated by physical exam, vital signs, pulse oximetry, clinical laboratory tests, and other adverse events (AEs).
What is the current status of trial NCT01451385?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 376 participants. The study started on 2011-09-20. Estimated completion is 2012-06-18.
What conditions does trial NCT01451385 study?
This clinical trial studies the following conditions: Osteoarthritis, Low Back Pain.
What interventions are being tested in trial NCT01451385?
The interventions under investigation include: COV795 (DRUG).
Who is sponsoring clinical trial NCT01451385?
This trial is sponsored by Mallinckrodt, which has 69 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01451385 being conducted?
This trial has 20 study locations across Arizona, California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Osteoarthritis
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 NCT01451385's enrollment target sits among peer trials
376 34th of 135 higher than 102 of 135 other Osteoarthritis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Osteoarthritis 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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