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

NCT ID: NCT00904397

Last Updated: 2010-02-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Lidoderm

Lidocaine patch 5% (Lidoderm®, Endo Pharmaceuticals Inc.), 2 patches applied once daily (q24h) directly to the most painful area of the low back

Group Type: EXPERIMENTAL

Lidoderm®

Intervention Type: 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

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

Group Type: ACTIVE_COMPARATOR

Celecoxib

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Lidocaine patch 5%

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Endo Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Endo Pharmaceuticals Inc.

Principal Investigators

Sr. Director

Role: STUDY_DIRECTOR

Endo Pharmaceuticals

Locations

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

Bethpage, 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

Countries

United States

Other Identifiers

EN3220-013

Identifier Type: -

Identifier Source: org_study_id