Lidocaine Patch 5% Versus Celecoxib 200 mg in Chronic Axial Low Back Pain
Overview[ - collapse ][ - ]
| Purpose | 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. |
|---|---|
| Condition | Chronic Low Back Pain |
| Intervention | Drug: Lidoderm® Drug: Celecoxib |
| Phase | Phase 4 |
| Sponsor | Endo Pharmaceuticals |
| Responsible Party | Endo Pharmaceuticals |
| ClinicalTrials.gov Identifier | NCT00904397 |
| First Received | May 15, 2009 |
| Last Updated | February 12, 2010 |
| Last verified | February 2010 |
Tracking Information[ + expand ][ + ]
| First Received Date | May 15, 2009 |
|---|---|
| Last Updated Date | February 12, 2010 |
| Start Date | July 2004 |
| Estimated Primary Completion Date | Not Provided |
| Current Primary Outcome Measures | 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)] [Designated as safety issue: No] |
| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | Lidocaine Patch 5% Versus Celecoxib 200 mg in Chronic Axial Low Back Pain |
|---|---|
| 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 |
| Brief 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 and without radiation. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 4 |
| Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment |
| Condition | Chronic Low Back Pain |
| Intervention | Drug: Lidoderm® 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. Other Names: Lidocaine patch 5%Drug: Celecoxib 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 Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Terminated |
|---|---|
| Estimated Enrollment | 98 |
| Estimated Completion Date | Not Provided |
| Estimated Primary Completion Date | November 2004 |
| Eligibility Criteria | Inclusion Criteria: 1. 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% 2. Had daily moderate to severe LBP as the primary source of pain 3. Had a normal neurological examination, including: - Motor strength - Sensory exam in lower extremities - Deep tendon reflexes 4. Had a normal 12-lead electrocardiogram (ECG) without any clinically significant abnormalities in heart rate, rhythm, or conduction 5. 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 6. 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 Exclusion Criteria: 1. Had spinal stenosis with >50% leg pain component 2. Had any other chronic pain condition that, in the opinion of the investigator, would interfere with patient assessment of LBP relief 3. Had a history of one or more back surgeries within 1 year of study entry 4. Had a moderate or greater hepatic impairment 5. Had a severe renal insufficiency (creatinine clearance of <30 mL/min) 6. Had experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs) 7. Had a prior history of peptic ulcer disease and/or gastrointestinal (GI) bleeding 8. 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. 9. Were taking long-acting opioids or opioids that could not be discontinued over the first 5 days of the washout period 10. Were receiving fluconazole or lithium (secondary to drug-drug-interaction risks with celecoxib) 11. Had received an epidural steroid/local anesthetic injection within 4 weeks prior to study entry 12. Had received trigger point injections within 2 weeks prior to study entry 13. Had received Botulinum Toxin (Botox) injections for LBP within 6 months prior to study entry 14. Were using a lidocaine-containing product that cannot be discontinued during the study 15. Were using any topical medication applied to the low back region 16. Had previously failed treatment with Lidoderm analgesic patch for LBP 17. Had previously failed treatment with celecoxib or with any two COX-2 specific inhibitors other than celecoxib 18. Were taking class I anti-arrhythmic (e.g. mexiletine, tocainide) 19. Had a history of alcohol or substance abuse within the last 3 years |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | United States |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00904397 |
|---|---|
| Other Study ID Numbers | EN3220-013 |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | Endo Pharmaceuticals |
| Study Sponsor | Endo Pharmaceuticals |
| Collaborators | Not Provided |
| Investigators | Study Director: Sr. Director Endo Pharmaceuticals |
| Verification Date | February 2010 |
Locations[ + expand ][ + ]
| United States, Alabama | Northport, Alabama, United States |
|---|---|
| United States, Arizona | Phoenix, Arizona, United States |
| United States, California | Beverly Hills, California, United States |
| United States, California | Encinitas, California, United States |
| United States, California | San Diego, California, United States |
| United States, California | Spring Valley, California, United States |
| United States, Florida | Longwood, Florida, United States |
| United States, Florida | North Miami Beach, Florida, United States |
| United States, Florida | Plantation, Florida, United States |
| United States, Illinois | Chicago, Illinois, United States |
| United States, Louisiana | Shreveport, Louisiana, United States |
| United States, Massachusetts | Boston, Massachusetts, United States |
| United States, New Jersey | Berlin, New Jersey, United States |
| United States, New York | Beth Page, New York, United States |
| United States, New York | Tonawanda, New York, United States |
| United States, North Carolina | Charlotte, North Carolina, United States |
| United States, Ohio | Dayton, Ohio, United States |
| United States, Pennsylvania | Allentown, Pennsylvania, United States |
| United States, Pennsylvania | Sellersville, Pennsylvania, United States |
| United States, South Carolina | Greer, South Carolina, United States |
| United States, Washington | Spokane, Washington, United States |