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Completed

NCT Number: NCT00281645

Long-Term Safety Study of Bicifadine for the Treatment of Chronic Low Back Pain

The primary objective of the study is to evaluate the safety and efficacy of bicifadine 400 mg BID for up to one year in patients with moderate to severe chronic low back pain.

The secondary objectives are to compare the long-term safety of bicifadine to standard of care therapy, to evaluate the safety of bicifadine following discontinuation of dosing, and to evaluate the safety and efficacy of lower doses of bicifadine in patients who do not tolerate bicifadine 400 mg BID.

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Key information

Conditions

Chronic Low Back Pain

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

There are two ways by which subjects could enter this study.

Subjects who completed 12 weeks of treatment in two other double blind clinical studies of bicifadine (Studies 020 and 021, both in the United States) could roll over into this study.

Also, de novo subjects (that is, subjects who had not previously received bicifadine) could enroll in this study.

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 over the past 3 months prior to screening.

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) or weakness in the lower extremities.
  • Patients must not have had epidural corticosteroid injections in the lower back within 1 month prior to baseline.
  • Patients may not have an unstable medical condition.

Treatment and study plan

Bicifadine

Drug

Standard of Care (pharmacological analgesic treatment)

Drug

Primary outcomes

  1. Adverse Events

  2. Clinical Labs

  3. Vital Signs

  4. ECGs

Secondary outcomes

  1. Pain Severity Rating (VAS)

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

  3. Roland-Morris Disability Questionnaire (RDQ)

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

  5. Patient Withdrawal Checklist

Sponsors and collaborators

Lead sponsor

DOV Pharmaceutical, Inc.

Industry

Registry information

Official study title

A Multicenter Standard of Care-Controlled Study to Evaluate the Long-Term Safety of Bicifadine for the Treatment of Chronic Low Back Pain

Important dates

Study start
2004
First posted
Jan 25, 2006
Registry last updated
Mar 27, 2007

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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