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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: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
|---|---|
|
Experimental: 1
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
Other Name: Neurontin
|
|
Sham Comparator: 2
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
Other Name: sugar pill
|
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: | Atkinson, Joseph - Principal Investigator, Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00108550 History of Changes |
| Other Study ID Numbers: | CLNA-013-04S |
| Study First Received: | April 15, 2005 |
| Last Updated: | December 8, 2010 |
| Health Authority: | United States: Federal Government |
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analgesia antidepressant agents back pain pain |
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Back Pain Low Back Pain Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms Antidepressive Agents Gabapentin Psychotropic Drugs Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Analgesics Sensory System Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Anticonvulsants Antiparkinson Agents Anti-Dyskinesia Agents Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Antimanic Agents |