Chronic Low Back PainPhase 3NCT00281645
Long-Term Safety Study of Bicifadine for 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 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Bicifadine
- How many people
- 1,250 participants
- Where
- No sites listed yet
- Study dates
- Dec 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 years and older
- 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 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.
About this study
Official title: A Multicenter Standard of Care-Controlled Study to Evaluate the Long-Term Safety 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.
Read the detailed description
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.
- Conditions
- Chronic Low Back Pain
- Being tested
- Bicifadine, Standard of Care (pharmacological analgesic treatment)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BicifadineDrug
Standard of Care (pharmacological analgesic treatment)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Clinical Labs
Vital Signs
ECGs
Secondary outcomes (5)
Pain Severity Rating (VAS)
Short-Form McGill Pain Questionnaire (SF-MPQ)
Roland-Morris Disability Questionnaire (RDQ)
Short-Form 36 (SF-36) Health Survey
Patient Withdrawal Checklist
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2006 (estimated)
- Study startDec 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
- None (open label)
- Enrolment
- 1,250 participants
Sponsor and investigators
- Lead sponsor
- DOV Pharmaceutical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00281645
- Sponsor's protocol ID
- DOV-075-022
- Status last verified
- Mar 2007
- First submitted
- 23 Jan 2006
- Last updated
- 27 Mar 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Standard of Care-Controlled Study to Evaluate the Long-Term Safety of Bicifadine for the Treatment of Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT00281645
- Acronym / sponsor ID
- DOV-075-022
- Conditions
- Chronic Low Back Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,250 participants
- Lead sponsor
- DOV Pharmaceutical, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2004
- First posted
- 25 Jan 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 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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- 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 | – |
| Standard of Care (pharmacological analgesic treatment) | Drug | – |
Primary outcome
Adverse Events
Clinical Labs
Vital Signs
ECGs
5 secondary outcomes
Pain Severity Rating (VAS)
Short-Form McGill Pain Questionnaire (SF-MPQ)
Roland-Morris Disability Questionnaire (RDQ)
Short-Form 36 (SF-36) Health Survey
Patient Withdrawal Checklist
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 27 Mar 2007.
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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 27 Mar 2007. 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?
Adverse Events. The study lists 4 primary outcomes in all. 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 27 Mar 2007.