Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Renovis |
---|---|
Information provided by: | Renovis |
ClinicalTrials.gov Identifier: | NCT00107055 |
The purpose of this study is to gain initial safety and efficacy data on the experimental agent REN-1654 in patients with pain that radiates down the leg(s), and is typical of sciatica (lumbosacral radiculopathy). These patients will usually have a herniated disc that is causing compression on the nerves coming out of the spinal column.
Condition | Intervention | Phase |
---|---|---|
Sciatica Herniated Disc Radiculopathy |
Drug: REN-1654 |
Phase II |
Study Type: | Interventional |
Study Design: | Educational/Counseling/Training, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | REN-1654 in Sciatica: A Phase 2, Randomized, Double-Blind, Placebo Controlled, Multi-Center Study in Subjects With Pain Due to Lumbosacral Radiculopathy |
Estimated Enrollment: | 72 |
Study Start Date: | December 2003 |
Estimated Study Completion Date: | April 2005 |
This is a multi-center, randomized, double-blind, placebo-controlled study to determine the efficacy and tolerability of REN-1654 in subjects with sciatica. After screening and baseline clinical assessments, subjects will be randomly assigned to receive REN 1654 100 mg or matching placebo, once daily for 3 weeks. Leg pain, back pain and other efficacy measures will be assessed at 1 and 3 weeks after initiation of treatment. A subset of patients will undergo analysis of blood levels of REN-1654 during the course of the study (pharmacokinetics). Subjects will discontinue treatment after 3 weeks and return after a further 3 weeks off therapy for a final clinical assessment 6 weeks after initiation of treatment. If a subject does not return for follow-up, an effort will be made by telephone to document their clinical status and whether other interventions have been made.
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
History of the following ophthalmic disorders based upon general medical review at the screening visit. Subjects will further undergo a screening ophthalmologic assessment. Should any of the following be identified at the screening ophthalmologic examination, the subject will be excluded from the study.
United States, Alabama | |
Alabama Clinical Therapeutics | |
Birmingham, Alabama, United States, 35235 | |
United States, Arizona | |
Advanced Clinical Therapeutics, LLC | |
Tuscon, Arizona, United States, 85712 | |
United States, California | |
Orthopaedic Spine Center at Stanford University Medical Center | |
Stanford, California, United States, 94305 | |
United States, Colorado | |
Mile High Research Center | |
Denver, Colorado, United States, 80218 | |
United States, Florida | |
Clinical Research of West Florida | |
Clearwater, Florida, United States, 33765 | |
Renstar Medical Research, Inc. | |
Ocala, Florida, United States, 34471 | |
Suncoast Neuroscience Associates | |
St. Petersburg, Florida, United States, 33701 | |
United States, Georgia | |
Emory Orthopaedics and Spine Center | |
Atlanta, Georgia, United States, 30329 | |
United States, Massachusetts | |
Brigham & Women's Hospital, Pain Trials Center | |
Boston, Massachusetts, United States, 02115 | |
United States, Missouri | |
A&A Pain Institute of St. Louis | |
St. Louis, Missouri, United States, 63141 | |
Washington University School of Medicine, Pain Management Center | |
St. Louis, Missouri, United States, 63110 | |
United States, New York | |
Research Across America | |
New York, New York, United States, 10022 | |
United States, North Carolina | |
Asheville Neurology Specialists, PA | |
Asheville, North Carolina, United States, 28806 | |
Wake Research Associates | |
Raleigh, North Carolina, United States, 27612 | |
United States, Ohio | |
The Cleveland Clinic Spine Institute | |
Cleveland, Ohio, United States, 44195 | |
United States, Pennsylvania | |
Lehigh Valley Hospital Neurosciences and Pain Research | |
Allentown, Pennsylvania, United States, 18103 | |
United States, Rhode Island | |
Omega Medical Research | |
Warwick, Rhode Island, United States, 02886 | |
United States, Texas | |
Central Texas Spine Institute | |
Austin, Texas, United States, 78731 | |
United States, Utah | |
Advanced Clinical Research | |
West Jordan, Utah, United States, 84088 |
Study Director: | Randall W Moreadith, MD, PhD | Chief Medical Officer, Renovis, Inc. |
Study ID Numbers: | REN-1654-2-03 |
Study First Received: | April 4, 2005 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00107055 |
Health Authority: | United States: Food and Drug Administration |
Herniated nucleus pulposus Lumbosacral radiculopathy Anti-TNF alpha Tumor necrosis factor alpha |
Spinal Diseases Neuralgia Pain Mononeuropathies Bone Diseases Sciatica Signs and Symptoms |
Necrosis Musculoskeletal Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Radiculopathy Neurologic Manifestations Intervertebral Disk Displacement |
Sciatic Neuropathy Nervous System Diseases |