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Completed

NCT Number: NCT00295711

Efficacy and Safety of Bicifadine in the Treatment of Chronic Low Back Pain

The primary objectives of this placebo-controlled clinical trial are to evaluate the analgesic efficacy and safety of bicifadine at three oral dose levels compared with placebo in patients with moderate to severe chronic low back pain.

The secondary objectives are to investigate the dose-response relationship of three dose levels of bicifadine, to evaluate the clinical meaningfulness of bicifadine efficacy, to evaluate the effect of bicifadine on function and general quality of life, to describe the population pharmacokinetics of bicifadine in patients with chronic low back pain, and to evaluate safety following discontinuation of bicifadine treatment.

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Key information

Conditions

Chronic Low Back Pain

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Main 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 must have required on average daily analgesics for the treatment of low back pain for at least 3 months prior to dosing.

Main Exclusion Criteria:

  • Patients may not have 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.

Treatment and study plan

Bicifadine

Drug

Primary outcomes

  1. - Pain Severity Rating (100 mm visual analog scale)

Secondary outcomes

  1. Short-Form McGill Pain Questionnaire (SF-MPQ)

  2. Roland-Morris Disability Questionnaire (RDQ)

  3. Short-Form 36 (SF-36) Health Survey

  4. Patient's Global Impression of Change (7-point categorical scale)Physician's Global Impression of Change (7-point categorical scale)

  5. Patient's Global Evaluation of Study Medication (5-point categorical scale)

  6. Physician's Global Evaluation of Study Medication (5-point categorical scale)

  7. Incidence of study discontinuation due to lack of efficacy

  8. Plasma PK of bicifadine

Sponsors and collaborators

Lead sponsor

DOV Pharmaceutical, Inc.

Industry

Registry information

Official study title

A Multi-Center Double-Blind, Placebo-Controlled Randomized Study of Bicifadine 200 Mg BID, Bicifadine 300 Mg BID, and Bicifadine 400 Mg BID in the Treatment of Chronic Low Back Pain

Important dates

Study start
2004
First posted
Feb 24, 2006
Registry last updated
Jun 23, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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