Chronic Low Back PainPhase 4NCT00904397
Lidocaine Patch 5% Versus Celecoxib 200 mg in Chronic Axial Low Back Pain
A Phase 4 study testing Lidoderm® and Celecoxib in people with Chronic Low Back Pain, run by Endo USA Inc., a Keenova Therapeutics Company at 21 sites in United States.
Trial summary
Patients who had axial lower back pain (LBP) with or without radiation present for at least 3 months and had daily moderate to severe LBP as the primary source of pain participated in a Phase IV clinical trial to assess the efficacy of lidocaine patch 5% compared to celecoxib 200 mg in treating chronic axial LBP with… 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® and Celecoxib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 21 sitesUnited States
- Study dates
- Jul 2004to Nov 2004
- 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
- Had axial LBP with or without radiation present for at least 3 months as defined below:
- Chronic axial LBP without radiation: pain isolated to the axial low back without radiation into the buttock or below
- Chronic axial LBP with radiation: pain that radiated to the buttock or below. This patient group could include patients with radicular/neuropathic and non-radicular components with leg pain component <50%
- Had daily moderate to severe LBP as the primary source of pain
- Had a normal neurological examination, including:
- Motor strength
Show all 11Show fewer
- Sensory exam in lower extremities
- Deep tendon reflexes
- Had a normal 12-lead electrocardiogram (ECG) without any clinically significant abnormalities in heart rate, rhythm, or conduction
- Had discontinued use of all analgesic medications (including over-the-counter [OTC] analgesics), glucosamine, and chondroitin prior to randomization (patients were allowed limited use of analgesic medications for indications other than non-study pain
- At the baseline visit, patients were randomized to active treatment if they had an average daily pain intensity score of 5 or greater (on a 0 to 10 scale) for at least 3 days out of the 5 consecutive days immediately prior to the baseline visit; 0 was defined as "no pain" and 10 was defined as "pain as bad as ever imagined" as measured by Question 5 of the Brief Pain Inventory (BPI) and recorded in a diary
Who cannot join
- Had spinal stenosis with >50% leg pain component
- Had any other chronic pain condition that, in the opinion of the investigator, would interfere with patient assessment of LBP relief
- Had a history of one or more back surgeries within 1 year of study entry
- Had a moderate or greater hepatic impairment
- Had a severe renal insufficiency (creatinine clearance of <30 mL/min)
- Had experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs)
Show all 19Show fewer
- Had a prior history of peptic ulcer disease and/or gastrointestinal (GI) bleeding
- Were taking analgesic medications that could not be discontinued during the study. Patients taking these medications prior to the study were required to discontinue use for the duration of the study. Patients using opioid analgesics at study entry were required to taper off these medications.
- Were taking long-acting opioids or opioids that could not be discontinued over the first 5 days of the washout period
- Were receiving fluconazole or lithium (secondary to drug-drug-interaction risks with celecoxib)
- Had received an epidural steroid/local anesthetic injection within 4 weeks prior to study entry
- Had received trigger point injections within 2 weeks prior to study entry
- Had received Botulinum Toxin (Botox) injections for LBP within 6 months prior to study entry
- Were using a lidocaine-containing product that cannot be discontinued during the study
- Were using any topical medication applied to the low back region
- Had previously failed treatment with Lidoderm analgesic patch for LBP
- Had previously failed treatment with celecoxib or with any two COX-2 specific inhibitors other than celecoxib
- Were taking class I anti-arrhythmic (e.g. mexiletine, tocainide)
- Had a history of alcohol or substance abuse within the last 3 years
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
Study site
Allentown, Pennsylvania
Study site
Berlin, New Jersey
Study site
Bethpage, New York
Study site
Beverly Hills, California
Study site
Boston, Massachusetts
Study site
Charlotte, North Carolina
Study site
Chicago, Illinois
Study site
Dayton, Ohio
Study site
Encinitas, California
Study site
Greer, South Carolina
Study site
Longwood, Florida
Study site
North Miami Beach, Florida
Study site
Northport, Alabama
Study site
Phoenix, Arizona
Study site
Plantation, Florida
Study site
San Diego, California
Study site
Sellersville, Pennsylvania
Study site
Shreveport, Louisiana
Study site
Spokane, Washington
Study site
Spring Valley, California
Study site
Tonawanda, New York
About this study
Official title: A Randomized, Open-Label Study Comparing the Efficacy and Safety of Lidocaine Patch 5% With Celecoxib 200 mg in Patients With Chronic Axial Low Back Pain
Patients who had axial lower back pain (LBP) with or without radiation present for at least 3 months and had daily moderate to severe LBP as the primary source of pain participated in a Phase IV clinical trial to assess the efficacy of lidocaine patch 5% compared to celecoxib 200 mg in treating chronic axial LBP with and without radiation.
- Conditions
- Chronic Low Back Pain
- Being tested
- Lidoderm®, Celecoxib
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%
Patients participated in a 14-day washout period followed by a 12-week active treatment period. Eligible patients were randomized equally to one of two groups: lidocaine patch 5% or celecoxib 200 mg.
CelecoxibDrug
Patients participated in a 14-day washout period followed by a 12-week active treatment period. Eligible patients were randomized equally to one of two groups: lidocaine patch 5% or celecoxib 200 mg.
| Study group | Role | What they receive |
|---|---|---|
| Lidoderm | Experimental | Lidocaine patch 5% (Lidoderm®, Endo Pharmaceuticals Inc.), 2 patches applied once daily (q24h) directly to the most painful area of the low back Receives: Drug: Lidoderm® |
| Celecoxib | Active comparator | Celecoxib (Celebrex®, G.D. Searle \& Co., Chicago, IL), one 200 mg oral capsule QD Receives: Drug: Celecoxib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline to Week 12 in BPI average pain intensity score (Question 5).
Measured: Visit - V2 (Day 0), V3 (Day 14), V4 (Day 28), V5 (Day 42), V6 (Day 56), V7 (Day 84)
Secondary outcomes (11)
Mean change from baseline to Weeks 2, 4, 6, 8, and 12 in daily pain intensity score as measured by Questions 3, 4, 5, and 6 of the BPI
Measured: Visit - V2 (Day 0), V3 (Day 14), V4 (Day 28), V5 (Day 42), V6 (Day 56), V7 (Day 84)
Mean change from baseline to Weeks 2, 4, 6, 8, and 12 in BPI pain relief score (Question 8).
Measured: Visit - V2 (Day 0), V3 (Day 14), V4 (Day 28), V5 (Day 42), V6 (Day 56), V7 (Day 84)
Mean change from baseline to Weeks 2, 4, 6, 8, and 12 in PQAS composite scores
Measured: Visit - V2 (Day 0), V3 (Day 14), V4 (Day 28), V5 (Day 42), V6 (Day 56), V7 (Day 84)
Mean change from baseline to Weeks 2, 4, 6, 8, and 12 in Oswestry Disability Index composite scores
Measured: Visit - V2 (Day 0), V3 (Day 14), V4 (Day 28), V5 (Day 42), V6 (Day 56), V7 (Day 84)
Investigator's Global Impression of Change in LBP at Week 12 (or premature discontinuation)
Measured: Visit - V2 (Day 0), V3 (Day 14), V4 (Day 28), V5 (Day 42), V6 (Day 56), V7 (Day 84)
Patient's Global Impression of Change in LBP at Week 12 (or premature discontinuation)
Measured: Visit - V2 (Day 0), V3 (Day 14), V4 (Day 28), V5 (Day 42), V6 (Day 56), V7 (Day 84)
Investigator's Global Assessment of Treatment Satisfaction at Week 12 (or premature discontinuation)
Measured: Visit - V2 (Day 0), V3 (Day 14), V4 (Day 28), V5 (Day 42), V6 (Day 56), V7 (Day 84)
Patient's Global Assessment of Treatment Satisfaction at Week 12 (or premature discontinuation)
Measured: Visit - V2 (Day 0), V3 (Day 14), V4 (Day 28), V5 (Day 42), V6 (Day 56), V7 (Day 84)
Safety assessments included AEs (including discontinuation due to AEs).
Measured: Visit - V2 (Day 0), V3 (Day 14), V4 (Day 28), V5 (Day 42), V6 (Day 56), V7 (Day 84)
Safety assessments included dermal assessment (lidocaine group only), skin sensory testing (lidocaine group only), clinical laboratory test results (including urinalysis, vital signs measurements, physical and neurological examinations, and body weight.
Measured: Visit - V2 (Day 0), V3 (Day 14), V4 (Day 28), V5 (Day 42), V6 (Day 56), V7 (Day 84)
Safety assessments included plasma lidocaine concentrations (lidocaine group only).
Measured: Visit - V2 (Day 0), V3 (Day 14), V4 (Day 28), V5 (Day 42), V6 (Day 56), V7 (Day 84)
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 startJul 2004
- Primary completionNov 2004
Why it stopped: Rofecoxib was withdrawn from the market due to safety concerns.
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
- 98 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
- NCT00904397
- Sponsor's protocol ID
- EN3220-013
- 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 Randomized, Open-Label Study Comparing the Efficacy and Safety of Lidocaine Patch 5% With Celecoxib 200 mg in Patients With Chronic Axial Low Back Pain
- ClinicalTrials.gov ID
- NCT00904397
- Acronym / sponsor ID
- EN3220-013
- Conditions
- Chronic Low Back Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Rofecoxib was withdrawn from the market due to safety concerns.
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics CompanyIndustry (pharma, biotech, devices)
- Study start
- Jul 2004
- Primary completion
- Nov 2004 (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 who had axial lower back pain (LBP) with or without radiation present for at least 3 months and had daily moderate to severe LBP as the primary source of pain participated in a Phase IV clinical trial to assess the efficacy of lidocaine patch 5% compared to celecoxib 200 mg in treating chronic axial LBP with and without radiation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidoderm | Experimental | Drug: Lidoderm®Lidocaine patch 5% (Lidoderm®, Endo Pharmaceuticals Inc.), 2 patches applied once daily (q24h) directly to the most painful area of the low back |
| Celecoxib | Active comparator | Drug: CelecoxibCelecoxib (Celebrex®, G.D. Searle \& Co., Chicago, IL), one 200 mg oral capsule QD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Had axial LBP with or without radiation present for at least 3 months as defined below:
- Had daily moderate to severe LBP as the primary source of pain
- Had a normal neurological examination, including:
- Had a normal 12-lead electrocardiogram (ECG) without any clinically significant abnormalities in heart rate, rhythm, or conduction
- Had discontinued use of all analgesic medications (including over-the-counter [OTC] analgesics), glucosamine, and chondroitin prior to randomization (patients were allowed limited use of analgesic medications for indications other than non-study pain
Key exclusion criteria (19 listed)
- Had spinal stenosis with >50% leg pain component
- Had any other chronic pain condition that, in the opinion of the investigator, would interfere with patient assessment of LBP relief
- Had a history of one or more back surgeries within 1 year of study entry
- Had a moderate or greater hepatic impairment
- Had a severe renal insufficiency (creatinine clearance of <30 mL/min)
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%Patients participated in a 14-day washout period followed by a 12-week active treatment period. Eligible patients were randomized equally to one of two groups: lidocaine patch 5% or celecoxib 200 mg. | Drug | Lidoderm |
| CelecoxibPatients participated in a 14-day washout period followed by a 12-week active treatment period. Eligible patients were randomized equally to one of two groups: lidocaine patch 5% or celecoxib 200 mg. | Drug | Celecoxib |
Primary outcome
Mean change from baseline to Week 12 in BPI average pain intensity score (Question 5).
Time frame: Visit - V2 (Day 0), V3 (Day 14), V4 (Day 28), V5 (Day 42), V6 (Day 56), V7 (Day 84)
11 secondary outcomes
Mean change from baseline to Weeks 2, 4, 6, 8, and 12 in daily pain intensity score as measured by Questions 3, 4, 5, and 6 of the BPI
Time frame: Visit - V2 (Day 0), V3 (Day 14), V4 (Day 28), V5 (Day 42), V6 (Day 56), V7 (Day 84)
Mean change from baseline to Weeks 2, 4, 6, 8, and 12 in BPI pain relief score (Question 8).
Time frame: Visit - V2 (Day 0), V3 (Day 14), V4 (Day 28), V5 (Day 42), V6 (Day 56), V7 (Day 84)
Mean change from baseline to Weeks 2, 4, 6, 8, and 12 in PQAS composite scores
Time frame: Visit - V2 (Day 0), V3 (Day 14), V4 (Day 28), V5 (Day 42), V6 (Day 56), V7 (Day 84)
Mean change from baseline to Weeks 2, 4, 6, 8, and 12 in Oswestry Disability Index composite scores
Time frame: Visit - V2 (Day 0), V3 (Day 14), V4 (Day 28), V5 (Day 42), V6 (Day 56), V7 (Day 84)
Investigator's Global Impression of Change in LBP at Week 12 (or premature discontinuation)
Time frame: Visit - V2 (Day 0), V3 (Day 14), V4 (Day 28), V5 (Day 42), V6 (Day 56), V7 (Day 84)
Patient's Global Impression of Change in LBP at Week 12 (or premature discontinuation)
Time frame: Visit - V2 (Day 0), V3 (Day 14), V4 (Day 28), V5 (Day 42), V6 (Day 56), V7 (Day 84)
Investigator's Global Assessment of Treatment Satisfaction at Week 12 (or premature discontinuation)
Time frame: Visit - V2 (Day 0), V3 (Day 14), V4 (Day 28), V5 (Day 42), V6 (Day 56), V7 (Day 84)
Patient's Global Assessment of Treatment Satisfaction at Week 12 (or premature discontinuation)
Time frame: Visit - V2 (Day 0), V3 (Day 14), V4 (Day 28), V5 (Day 42), V6 (Day 56), V7 (Day 84)
Safety assessments included AEs (including discontinuation due to AEs).
Time frame: Visit - V2 (Day 0), V3 (Day 14), V4 (Day 28), V5 (Day 42), V6 (Day 56), V7 (Day 84)
Safety assessments included dermal assessment (lidocaine group only), skin sensory testing (lidocaine group only), clinical laboratory test results (including urinalysis, vital signs measurements, physical and neurological examinations, and body weight.
Time frame: Visit - V2 (Day 0), V3 (Day 14), V4 (Day 28), V5 (Day 42), V6 (Day 56), V7 (Day 84)
Safety assessments included plasma lidocaine concentrations (lidocaine group only).
Time frame: Visit - V2 (Day 0), V3 (Day 14), V4 (Day 28), V5 (Day 42), V6 (Day 56), V7 (Day 84)
Results and safety
The study was stopped early (reason given: Rofecoxib was withdrawn from the market due to safety concerns.). Results are not available in the source record.
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
21 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® and Celecoxib in people with Chronic Low Back Pain, run by Endo USA Inc., a Keenova Therapeutics Company at 21 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 11 inclusion and 19 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: stopped early, 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 21 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. 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 was stopped early (reason given: Rofecoxib was withdrawn from the market due to safety concerns.). Results are not available in the source record.
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 from baseline to Week 12 in BPI average pain intensity score (Question 5). (time frame: Visit - V2 (Day 0), V3 (Day 14), V4 (Day 28), V5 (Day 42), V6 (Day 56), V7 (Day 84)). 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.