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Lidocaine Patch 5% Versus Celecoxib 200 mg in Chronic Axial Low Back Pain

Information source: Endo Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Low Back Pain

Intervention: Lidoderm® (Drug); Celecoxib (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: Endo Pharmaceuticals

Official(s) and/or principal investigator(s):
Sr. Director, Study Director, Affiliation: Endo Pharmaceuticals

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Mean change from baseline to Week 12 in BPI average pain intensity score (Question 5).

Secondary outcome:

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

Mean change from baseline to Weeks 2, 4, 6, 8, and 12 in BPI pain relief score (Question 8).

Mean change from baseline to Weeks 2, 4, 6, 8, and 12 in PQAS composite scores

Mean change from baseline to Weeks 2, 4, 6, 8, and 12 in Oswestry Disability Index composite scores

Investigator's Global Impression of Change in LBP at Week 12 (or premature discontinuation)

Patient's Global Impression of Change in LBP at Week 12 (or premature discontinuation)

Investigator's Global Assessment of Treatment Satisfaction at Week 12 (or premature discontinuation)

Patient's Global Assessment of Treatment Satisfaction at Week 12 (or premature discontinuation)

Safety assessments included AEs (including discontinuation due to AEs).

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.

Safety assessments included plasma lidocaine concentrations (lidocaine group only).

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Northport, Alabama, United States

Phoenix, Arizona, United States

Beverly Hills, California, United States

Encinitas, California, United States

San Diego, California, United States

Spring Valley, California, United States

Longwood, Florida, United States

North Miami Beach, Florida, United States

Plantation, Florida, United States

Chicago, Illinois, United States

Shreveport, Louisiana, United States

Boston, Massachusetts, United States

Berlin, New Jersey, United States

Beth Page, New York, United States

Tonawanda, New York, United States

Charlotte, North Carolina, United States

Dayton, Ohio, United States

Allentown, Pennsylvania, United States

Sellersville, Pennsylvania, United States

Greer, South Carolina, United States

Spokane, Washington, United States

Additional Information

Starting date: July 2004
Last updated: February 12, 2010

Page last updated: August 23, 2015

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