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Sponsored by: |
Department of Veterans Affairs |
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Information provided by: | Department of Veterans Affairs |
ClinicalTrials.gov Identifier: | NCT00108550 |
The purpose of this study is to determine whether gabapentin is efficacious as an analgesic for chronic low back pain.
Condition | Intervention | Phase |
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Chronic Low Back Pain |
Drug: gabapentin Drug: Inert placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Efficacy of Antidepressants in Chronic Back Pain |
Estimated Enrollment: | 130 |
Study Start Date: | October 2004 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Gabapentin 300 to 3600 mg daily by mouth
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Drug: gabapentin
Gabapentin 300m on Day 1, with daily or weekly increase to 3600 mg (maximum) by mouth by Week 5 of the 12-week trial
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2: Sham Comparator
Inert placebo capsule identical in size and shape to the experimental capsule
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Drug: Inert placebo
Inactive placebo capsule, one capsule on Day 1 with daily or weekly increase to 9 capsules daily by Week 5 of the 12-week trial
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Ages Eligible for Study: | 21 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Judy Ortega, BA | (858) 642-3830 | judith.ortega@va.gov |
Contact: Shetal Patel, PhD | (858) 642-3830 | backpainresearch@vapop.ucsd.edu |
United States, California | |
VA San Diego Healthcare System, San Diego | Recruiting |
San Diego, California, United States, 92161 | |
Contact: Judy Ortega, BA 858-642-3830 judith.ortega@va.gov | |
Contact: Shetal Patel, PhD (858) 642-3830 backpainresearch@vapop.ucsd.edu | |
Principal Investigator: Joseph H. Atkinson, MD |
Principal Investigator: | Joseph H. Atkinson, MD | VA San Diego Healthcare System, San Diego |
Responsible Party: | Department of Veterans Affairs ( Atkinson, Joseph - Principal Investigator ) |
Study ID Numbers: | CLNA-013-04S |
Study First Received: | April 15, 2005 |
Last Updated: | August 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00108550 |
Health Authority: | United States: Federal Government |
analgesia antidepressant agents back pain pain |
Excitatory Amino Acids Calcium, Dietary Signs and Symptoms Gabapentin |
Neurologic Manifestations Low Back Pain Pain Back Pain |
Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Nervous System Diseases Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Antiparkinson Agents Calcium Channel Blockers Excitatory Amino Acid Agents Cardiovascular Agents |
Antimanic Agents Pharmacologic Actions Membrane Transport Modulators Sensory System Agents Therapeutic Uses Anti-Anxiety Agents Analgesics Peripheral Nervous System Agents Central Nervous System Agents Anticonvulsants Excitatory Amino Acid Antagonists |