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Clinical Trials/NCT00295724
NCT00295724
Completed
Phase 3

A Multi-Center, Double-Blind, Placebo-Controlled Randomized Study of Bicifadine 200 mg BID in the Treatment of Chronic Low Back Pain

DOV Pharmaceutical, Inc.0 sitesOctober 2005
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ConditionsChronic Low Back Pain
DrugsBicifadine

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Chronic Low Back Pain
Sponsor
DOV Pharmaceutical, Inc.
Primary Endpoint
Pain Severity Rating (100 mm visual analog scale)
Status
Completed
Last Updated
19 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

  • The primary objectives of this placebo-controlled clinical trial are to evaluate the analgesic efficacy and safety of bicifadine 200 mg BID compared with placebo in patients with moderate to severe chronic low back pain.
  • The secondary objectives are to evaluate the effect of bicifadine on function and general quality of life, to evaluate safety following discontinuation of bicifadine treatment and to investigate the population pharmacokinetics of bicifadine.
Registry
clinicaltrials.gov
Start Date
October 2005
End Date
TBD
Last Updated
19 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •Patients with low back pain assessed as Class 1, Class 2 or Class 3 according to the Quebec Task Force Classification for Spinal Disorders and without detectable leg weakness on neurological examination.
  • •Patients with pain categorized as Class 1 according to the Quebec Task Force Classification must have a Roland-Morris Disability Rating of \>17 at baseline to qualify. Patients with pain categorized as Class 2 or Class 3 according to the Quebec Task Force Classification must have a Roland-Morris Disability Rating of at least 10 at baseline to qualify.
  • •Patients must have required daily analgesics for the treatment of low back pain for at least 3 months prior dosing.

Exclusion Criteria

  • •Patients may not have persistent moderate or severe pain in a location other than the lower back (with the exception of radiation to the lower extremity).
  • •Patients must not have had lower back surgery within 6 months prior to baseline, nor epidural corticosteroid injections within 3 months prior to baseline.
  • •Patients may not have an unstable medical condition.

Outcomes

Primary Outcomes

Pain Severity Rating (100 mm visual analog scale)

Secondary Outcomes

  • Short-Form McGill Pain Questionnaire (SF-MPQ)
  • Roland-Morris Disability Questionnaire (RDQ)
  • Short-Form 36 (SF-36) Health Survey
  • Patient's Global Impression of Change (7-point categorical scale)

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