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| Sponsor: | Department of Veterans Affairs |
|---|---|
| Information provided by: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00108550 |
Purpose
The purpose of this study is to determine whether gabapentin is efficacious as an analgesic for chronic low back pain.
| Condition | Intervention | Phase |
|---|---|---|
|
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 |
| Enrollment: | 115 |
| Study Start Date: | October 2004 |
| Study Completion Date: | September 2009 |
| Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Gabapentin 300 to 3600 mg daily by mouth
|
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
|
|
2: Sham Comparator
Inert placebo capsule identical in size and shape to the experimental capsule
|
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
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 21 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| VA San Diego Healthcare System, San Diego | |
| San Diego, California, United States, 92161 | |
| Principal Investigator: | Joseph H. Atkinson, MD | VA San Diego Healthcare System, San Diego |
More Information
| Responsible Party: | Department of Veterans Affairs ( Atkinson, Joseph - Principal Investigator ) |
| Study ID Numbers: | CLNA-013-04S |
| Study First Received: | April 15, 2005 |
| Last Updated: | September 17, 2009 |
| ClinicalTrials.gov Identifier: | NCT00108550 History of Changes |
| Health Authority: | United States: Federal Government |
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analgesia antidepressant agents back pain pain |
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Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Gabapentin Anti-Dyskinesia Agents Physiological Effects of Drugs Psychotropic Drugs Antiparkinson Agents Calcium Channel Blockers Excitatory Amino Acid Agents Pain Membrane Transport Modulators Signs and Symptoms Sensory System Agents Therapeutic Uses Analgesics |
Antidepressive Agents Excitatory Amino Acid Antagonists Tranquilizing Agents Nervous System Diseases Central Nervous System Depressants Low Back Pain Cardiovascular Agents Antimanic Agents Back Pain Pharmacologic Actions Neurologic Manifestations Anti-Anxiety Agents Peripheral Nervous System Agents Central Nervous System Agents Anticonvulsants |