CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 108 enrolled
Drug / intervention
gabapentin +1 moredrug
Likely dose
Gabapentin 300 mg on Day 1 with daily or weekly increase to maximum 3600 mg daily by Week 5AI-extracted
Key inclusion· 5
  • ✓Age 21-70 years inclusive
  • ✓Low back pain at T-6 or below from degenerative disk or degenerative joint disease, present daily for ≥6 months, intensity >7 on Descriptor Differential Scale
  • ✓Not a surgical candidate (one prior surgery >5 years ago with complete relief permitted)
  • ✓Resident of San Diego County, California
Key exclusion· 12
  • ✕Major coexisting medical illness (diabetes, renal/hepatic disease, COPD, cancer, class III-IV heart disease) or major surgery within past 12 months
  • ✕Significant coexisting orthopedic/pain problems including sciatica or back pain from other causes (fibromyalgia, vertebral fracture, spinal stenosis, etc.)
  • ✕DSM-IV diagnosis of alcohol/substance abuse or dependence (within 12 months), current major depression/dysthymia, lifetime bipolar disorder, major anxiety disorder, psychosis, or lifetime cognitive impairment
  • ✕History of multiple adverse drug reactions or known allergy to gabapentin

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00108550
NCT00108550Phase 2Completed
CompareCT.gov

Efficacy of Antidepressants in Chronic Back Pain

US Department of Veterans Affairs·interventional·Posted Apr 18, 2005·Updated Feb 10, 2014

In Brief

A Phase 2 clinical trial evaluating gabapentin and Inert placebo for Chronic Low Back Pain. Completed, enrolled 108 participants across 1 site.

Detailed Summary

The purpose of this study is to determine whether gabapentin is efficacious as an analgesic for chronic low back pain.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Low Back Pain
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 18, 2005
Enrollment StartOct 1, 2004
Primary CompletionJul 1, 2009
Study CompletionSep 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 21.2 years ago

Interventions

gabapentindrug

Gabapentin 300m on Day 1, with daily or weekly increase to 3600 mg (maximum) by mouth by Week 5 of the 12-week trial

Inert placebodrug

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