Chronic Low Back PainPhase 3NCT00295711
Efficacy and Safety of Bicifadine in the Treatment of Chronic Low Back Pain
A Phase 3 study testing Bicifadine in people with Chronic Low Back Pain, run by DOV Pharmaceutical, Inc..
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Bicifadine
- How many people
- 532 participants
- Where
- No sites listed yet
- Study dates
- Sep 2004to not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
About this study
Official 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
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.
- Conditions
- Chronic Low Back Pain
- Being tested
- Bicifadine
- Keywords
- bicifadine, chronic low back pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BicifadineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
- Pain Severity Rating (100 mm visual analog scale)
Secondary outcomes (8)
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)Physician's Global Impression of Change (7-point categorical scale)
Patient's Global Evaluation of Study Medication (5-point categorical scale)
Physician's Global Evaluation of Study Medication (5-point categorical scale)
Incidence of study discontinuation due to lack of efficacy
Plasma PK of bicifadine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2006 (estimated)
- Study startSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 532 participants
Sponsor and investigators
- Lead sponsor
- DOV Pharmaceutical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00295711
- Sponsor's protocol ID
- DOV-075-020
- Status last verified
- Jun 2006
- First submitted
- 23 Feb 2006
- Last updated
- 23 Jun 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT00295711
- Acronym / sponsor ID
- DOV-075-020
- Conditions
- Chronic Low Back Pain
- Keywords
- bicifadine, chronic low back pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 532 participants
- Lead sponsor
- DOV Pharmaceutical, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2004
- First posted
- 24 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bicifadine | Drug | – |
Primary outcome
- Pain Severity Rating (100 mm visual analog scale)
8 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)Physician's Global Impression of Change (7-point categorical scale)
Patient's Global Evaluation of Study Medication (5-point categorical scale)
Physician's Global Evaluation of Study Medication (5-point categorical scale)
Incidence of study discontinuation due to lack of efficacy
Plasma PK of bicifadine
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bicifadine in people with Chronic Low Back Pain, run by DOV Pharmaceutical, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2006. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
- Pain Severity Rating (100 mm visual analog scale). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2006.