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

This study has been terminated.
(Rofecoxib was withdrawn from the market due to safety concerns.)
Sponsor:
Information provided by:
Endo Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00904397
First received: May 15, 2009
Last updated: February 12, 2010
Last verified: February 2010
  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 Intervention Phase
Chronic Low Back Pain
Drug: Lidoderm®
Drug: Celecoxib
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Endo Pharmaceuticals:

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 ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: Yes ]
  • 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) ] [ Designated as safety issue: Yes ]
  • 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) ] [ Designated as safety issue: Yes ]

Enrollment: 98
Study Start Date: July 2004
Primary Completion Date: November 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lidoderm
Lidocaine patch 5% (Lidoderm®, Endo Pharmaceuticals Inc.), 2 patches applied once daily (q24h) directly to the most painful area of the low back
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 Name: Lidocaine patch 5%
Active Comparator: Celecoxib
Celecoxib (Celebrex®, G.D. Searle & Co., Chicago, IL), one 200 mg oral capsule QD
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00904397

Locations
United States, Alabama
Northport, Alabama, United States
United States, Arizona
Phoenix, Arizona, United States
United States, California
Beverly Hills, California, United States
Encinitas, California, United States
San Diego, California, United States
Spring Valley, California, United States
United States, Florida
Longwood, Florida, United States
North Miami Beach, Florida, United States
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
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
Sellersville, Pennsylvania, United States
United States, South Carolina
Greer, South Carolina, United States
United States, Washington
Spokane, Washington, United States
Sponsors and Collaborators
Endo Pharmaceuticals
Investigators
Study Director: Sr. Director Endo Pharmaceuticals
  More Information

No publications provided

Responsible Party: Sr Director, Clinical R&D, Endo Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00904397     History of Changes
Other Study ID Numbers: EN3220-013
Study First Received: May 15, 2009
Last Updated: February 12, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Lidocaine
Celecoxib
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on August 26, 2014