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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

532 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Low Back Pain

Keywords

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bicifadine chronic low back pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Bicifadine

Intervention Type DRUG

Eligibility Criteria

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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.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Other Identifiers

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DOV-075-020

Identifier Type: -

Identifier Source: org_study_id