Chronic Low Back PainPhase 4NCT00904475
Pilot Study of the Efficacy and Safety of Lidoderm Patch in the Treatment of Low Back Pain
A Phase 4 study testing Lidoderm® in people with Chronic Low Back Pain, run by Endo USA Inc., a Keenova Therapeutics Company at 6 sites in United States.
Trial summary
Patients with moderate to severe chronic Low Back Pain (LBP) despite current analgesic treatment participated in a Phase IV clinical trial to evaluate the analgesic efficacy of the lidocaine patch 5% compared to placebo in treating moderate to severe chronic LBP. 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?
- Lidoderm®
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 6 sitesUnited States
- Study dates
- Apr 2003to Apr 2003
- Phase
- Phase 4
- 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
Who may be able to join
- Were currently experiencing moderate/severe pain despite current analgesic treatment
- Had daily moderate-to-severe LBP for at least 3 months duration
- Had a mean daily pain intensity score of >6 on a 0 to 10 scale, with 0 being no pain and 10 being pain as bad as the patients have ever imagined (Question 5 of BPI) during the baseline week; patients had to complete daily diary assessments at least 5 of 7 days during the baseline week
Who cannot join
- Had a history of greater than one back surgery, or one back surgery within 3 months of study entry
- Had severe spinal stenosis
- Had chronic back pain of >12 months duration with an undefined spinal diagnosis
- Had radicular symptoms with radiation into the thigh or below (i.e., knee, calf, foot, etc.)
- Had received an epidural steroid/local anesthetic injection within 2 weeks prior to study entry
- Had received trigger point injections within 2 weeks prior to study entry
Show all 10Show fewer
- Had received Botulinum Toxin Injections for LBP within 3 months prior to study entry
- Were taking a lidocaine-containing product that could not be discontinued while receiving study medication
- Were taking class 1 anti-arrhythmic drugs (e.g., mexiletine, tocainide)
- Had received Lidoderm for LBP in the past
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Study site
Allentown, Pennsylvania
Study site
Birmingham, Alabama
Study site
Hueytown, Alabama
Study site
Mill Valley, California
Study site
Phoenix, Arizona
Study site
Salt Lake City, Utah
About this study
Official title: A Prospective, Prospective, Double-blind, Randomized, Placebo-Controlled, Pilot Study of the Efficacy and Safety of Lidoderm Patch in the Treatment of Low Back Pain
Patients with moderate to severe chronic Low Back Pain (LBP) despite current analgesic treatment participated in a Phase IV clinical trial to evaluate the analgesic efficacy of the lidocaine patch 5% compared to placebo in treating moderate to severe chronic LBP.
- Conditions
- Chronic Low Back Pain
- Being tested
- Lidoderm®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidoderm®Drug
Also called Lidocaine patch 5%
Eligible patients were randomized equally to one of two groups: lidocaine patch 5% or matching placebo patch. During the 6-week treatment period, patients used up to three patches daily applied q24h.
Lidoderm®Drug
Also called Lidocaine patch 5%
Eligible patients were randomized equally to one of two groups: lidocaine patch 5% or matching placebo patch. During the 6-week treatment period, patients used up to three patches daily applied q24h.
| Study group | Role | What they receive |
|---|---|---|
| 1- Lidoderm® | Experimental | Lidoderm (lidocaine patch 5%), up to three patches applied topically once daily (q24h) to the area of maximal peripheral pain Receives: Drug: Lidoderm® |
| 2-Placebo | Placebo comparator | Matching placebo, up to three patches applied topically once daily (q24h) to the area of maximal peripheral pain Receives: Drug: Lidoderm® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in average daily pain intensity (BPI Question 5) from baseline week to the final week of treatment (primary endpoint)
Measured: Visit - V2 (Day 0), V3 (Day 7), V4 (Day 14), V5 (Day 28), V6/EOS (Day 42)
Secondary outcomes (6)
Mean change from baseline to Week 2 and Week6/EOS in average daily pain intensity (BPI Question 5)
Pain relief (BPI Question 8)
Mean change from baseline to Week 2 and Week 6 in Pain Quality Assessment Scale (PQAS)
Patient and Investigator Global Impression of Pain Relief at Week 6
QoL: Change from baseline to Week 6 in pain interference with QoL (BPI Question 9) and Profile of Mood States (POMS)
Safety assessments included AEs, discontinuations as a result of AEs, clinical laboratory tests, vital signs, physical examination, plasma lidocaine levels, dermal assessments and sking sensory testing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2009 (estimated)
- Study startApr 2003
- Primary completionApr 2003
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Sr. Director, Study director, Endo USA Inc., a Keenova Therapeutics Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00904475
- Sponsor's protocol ID
- EN3220-011
- Status last verified
- Feb 2010
- First submitted
- 15 May 2009
- Last updated
- 15 Feb 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Prospective, Double-blind, Randomized, Placebo-Controlled, Pilot Study of the Efficacy and Safety of Lidoderm Patch in the Treatment of Low Back Pain
- ClinicalTrials.gov ID
- NCT00904475
- Acronym / sponsor ID
- EN3220-011
- Conditions
- Chronic Low Back Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics CompanyIndustry (pharma, biotech, devices)
- Study start
- Apr 2003
- Primary completion
- Apr 2003 (actual)
- First posted
- 19 May 2009 (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.
Patients with moderate to severe chronic Low Back Pain (LBP) despite current analgesic treatment participated in a Phase IV clinical trial to evaluate the analgesic efficacy of the lidocaine patch 5% compared to placebo in treating moderate to severe chronic LBP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1- Lidoderm® | Experimental | Drug: Lidoderm®Lidoderm (lidocaine patch 5%), up to three patches applied topically once daily (q24h) to the area of maximal peripheral pain |
| 2-Placebo | Placebo comparator | Drug: Lidoderm®Matching placebo, up to three patches applied topically once daily (q24h) to the area of maximal peripheral pain |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Were currently experiencing moderate/severe pain despite current analgesic treatment
- Had daily moderate-to-severe LBP for at least 3 months duration
- Had a mean daily pain intensity score of >6 on a 0 to 10 scale, with 0 being no pain and 10 being pain as bad as the patients have ever imagined (Question 5 of BPI) during the baseline week; patients had to complete daily diary assessments at least 5 of 7 days during the baseline week
Key exclusion criteria (10 listed)
- Had a history of greater than one back surgery, or one back surgery within 3 months of study entry
- Had severe spinal stenosis
- Had chronic back pain of >12 months duration with an undefined spinal diagnosis
- Had radicular symptoms with radiation into the thigh or below (i.e., knee, calf, foot, etc.)
- Had received an epidural steroid/local anesthetic injection within 2 weeks prior to study entry
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 |
|---|---|---|
| Lidoderm®Also: Lidocaine patch 5%Eligible patients were randomized equally to one of two groups: lidocaine patch 5% or matching placebo patch. During the 6-week treatment period, patients used up to three patches daily applied q24h. | Drug | 1- Lidoderm® |
| Lidoderm®Also: Lidocaine patch 5%Eligible patients were randomized equally to one of two groups: lidocaine patch 5% or matching placebo patch. During the 6-week treatment period, patients used up to three patches daily applied q24h. | Drug | 2-Placebo |
Primary outcome
Mean change in average daily pain intensity (BPI Question 5) from baseline week to the final week of treatment (primary endpoint)
Time frame: Visit - V2 (Day 0), V3 (Day 7), V4 (Day 14), V5 (Day 28), V6/EOS (Day 42)
6 secondary outcomes
Mean change from baseline to Week 2 and Week6/EOS in average daily pain intensity (BPI Question 5)
Pain relief (BPI Question 8)
Mean change from baseline to Week 2 and Week 6 in Pain Quality Assessment Scale (PQAS)
Patient and Investigator Global Impression of Pain Relief at Week 6
QoL: Change from baseline to Week 6 in pain interference with QoL (BPI Question 9) and Profile of Mood States (POMS)
Safety assessments included AEs, discontinuations as a result of AEs, clinical laboratory tests, vital signs, physical examination, plasma lidocaine levels, dermal assessments and sking sensory testing
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 15 Feb 2010.
Related trials for Chronic Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
Enrolling by invitation
Effects of 3-dimensional Versus Dynamic Myofascial Release Techniques With Lumbar Mobilization and Exercise Therapy Program in Chronic Non-specific Low Back Pain.
Chronic Non-Specific Low Back Pain, Myofascial Release
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain
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.
Sr. Director study director
Endo USA Inc., a Keenova Therapeutics Company
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lidoderm® in people with Chronic Low Back Pain, run by Endo USA Inc., a Keenova Therapeutics Company at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. 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 15 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Mean change in average daily pain intensity (BPI Question 5) from baseline week to the final week of treatment (primary endpoint) (time frame: Visit - V2 (Day 0), V3 (Day 7), V4 (Day 14), V5 (Day 28), V6/EOS (Day 42)). 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 15 Feb 2010.