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

NCT00904397 | Terminated Phase 4

• 1 other identifier: EN3220-013
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 21

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.

Conditions

Chronic Low Back Pain

Outcome Measures

Primary Outcomes (1)

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

  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

  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).

  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

  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

  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)

  Visit - V2 (Day 0), V3 (Day 14), V4 (Day 28), V5 (Day 42), V6 (Day 56), V7 (Day 84)

Study Arms (2)

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

Drug: Lidoderm®

Celecoxib

ACTIVE COMPARATOR

Celecoxib (Celebrex®, G.D. Searle \& Co., Chicago, IL), one 200 mg oral capsule QD

Drug: Celecoxib

Interventions

Lidoderm® DRUG

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.

Also known as: Lidocaine patch 5%

Lidoderm

Celecoxib DRUG

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.

Celecoxib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Endo Pharmaceuticals: lead

Study Sites (21)

Unknown Facility

Northport, Alabama, United States

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Phoenix, Arizona, United States

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Beverly Hills, California, United States

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Encinitas, California, United States

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San Diego, California, United States

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Spring Valley, California, United States

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Longwood, Florida, United States

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North Miami Beach, Florida, United States

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Plantation, Florida, United States

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Chicago, Illinois, United States

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Shreveport, Louisiana, United States

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Boston, Massachusetts, United States

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Berlin, New Jersey, United States

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Bethpage, New York, United States

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Tonawanda, New York, United States

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Charlotte, North Carolina, United States

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Dayton, Ohio, United States

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Allentown, Pennsylvania, United States

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Sellersville, Pennsylvania, United States

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Greer, South Carolina, United States

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Spokane, Washington, United States

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MeSH Terms

Interventions

Lidoderm; Celecoxib

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Sr. Director

  Endo Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 15, 2009
• First Posted: May 19, 2009
• Study Start: July 1, 2004
• Primary Completion: November 1, 2004
• Last Updated: February 15, 2010

Record last verified: 2010-02

Locations

US (21)