|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Rib-X Pharmaceuticals, Inc. |
|---|---|
| Information provided by: | Rib-X Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT00646958 |
Purpose
The purpose of this study is to assess the efficacy, safety and tolerability of RX-1741, an oxazolidinone, versus linezolid, another oxazolidinone, in the treatment of uncomplicated skin and skin structure infections
| Condition | Intervention | Phase |
|---|---|---|
|
Infectious Skin Diseases Bacterial Skin Diseases Staphylococcal Skin Infections Streptococcal Infections Abscess |
Drug: Radezolid Drug: Linezolid |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 2, Multicenter, Randomized, Open-Label, Comparative Study to Evaluate the Safety and Efficacy of RX-1741 Versus Linezolid in the Outpatient Treatment of Adult Patients With Uncomplicated Skin and Skin Structure Infection |
| Enrollment: | 150 |
| Study Start Date: | December 2007 |
| Study Completion Date: | April 2008 |
| Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Radezolid 450 mg PO QD
|
Drug: Radezolid
450mg PO QD
Other Name: RX-1741
|
|
Experimental: 2
Radezolid 450 mg PO BID
|
Drug: Radezolid
450mg PO BID
Other Name: RX-1741
|
|
Active Comparator: 3
Linezolid 600 mg PO BID
|
Drug: Linezolid
600mg PO BID
Other Name: Zyvox
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Alabama | |
| Drug Research & Analysis Corp | |
| Montgomery, Alabama, United States | |
| United States, California | |
| OWENS Pharma Research Center | |
| Long Beach, California, United States | |
| Healthcare Partners Medical Group | |
| Los Angeles, California, United States | |
| HealthCare Partners Medical Group | |
| Pasadena, California, United States | |
| Olive View- UCLA Center, Dept. Emergency Medicine | |
| Sylmar, California, United States | |
| United States, Florida | |
| South Florida Clinical Research | |
| Atlantis, Florida, United States | |
| United States, Georgia | |
| Southeast Regional Research Group | |
| Columbus, Georgia, United States | |
| Contemporary Medicine, LLC | |
| Hinesville, Georgia, United States | |
| United States, Indiana | |
| Infectious Disease of Indiana, PSC. | |
| Indianapolis, Indiana, United States | |
| United States, Louisiana | |
| Clinical Trials of America, Inc. | |
| Shreveport, Louisiana, United States | |
| United States, Michigan | |
| Arnold Markowitz, MD., PC | |
| Keego Harbor, Michigan, United States | |
| United States, Montana | |
| Mercury Street Medical Group, LLC | |
| Butte, Montana, United States | |
| United States, New York | |
| Jamaica Hospital Medical Center | |
| Jamaica, New York, United States | |
| United States, North Carolina | |
| ALL-TRIALS Clinical Research, LLC | |
| Winston-Salem, North Carolina, United States | |
| United States, Ohio | |
| Summa Health System | |
| Akron, Ohio, United States | |
| United States, Pennsylvania | |
| Brandywine Clinical Research | |
| Downington, Pennsylvania, United States | |
| Warminster Medical Associates, P.C. | |
| Warminster, Pennsylvania, United States | |
| United States, Tennessee | |
| McKenzie Medical Center | |
| McKenzie, Tennessee, United States | |
| United States, Utah | |
| J. Lewis Research, Inc. | |
| Salt Lake City, Utah, United States | |
| Study Director: | Scott Hopkins, MD | Rib-X Pharmaceuticals, Inc. |
More Information
| Responsible Party: | Scott Hopkins, MD, Rib-X Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT00646958 History of Changes |
| Other Study ID Numbers: | RX-1741-202 |
| Study First Received: | March 26, 2008 |
| Results First Received: | March 24, 2009 |
| Last Updated: | June 25, 2009 |
| Health Authority: | United States: Food and Drug Administration |
|
Abscess Communicable Diseases Infection Skin Diseases Skin Diseases, Infectious Staphylococcal Skin Infections Streptococcal Infections Skin Diseases, Bacterial Suppuration Inflammation Pathologic Processes |
Staphylococcal Infections Gram-Positive Bacterial Infections Bacterial Infections Linezolid Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |