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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 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.
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).
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01451385
The ClinicalTrials.gov registry entry for NCT01451385 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 376 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 815-participant average among 135 other Osteoarthritis trials with a reported enrollment target (54% lower). The listed sponsor is Mallinckrodt, which has 69 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 3 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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