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

Original Study ID : EN3220-013

NCT ID : NCT00904397

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.

Source : Endo Pharmaceuticals

Overall Status : Terminated

Start Date : July 2004

Official Title : Phase 4

Phase : Interventional

Study Design : Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Efficacy Study

Enrollment : 98

Verification Date : May 2009

First Received Date : May 15, 2009

Trial 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

Minimum Age : 18 Years

Maximum Age : N/A

Healthy Volunteers : No

Facilities

City : Northport

State : Alabama

Country : United States

City : Phoenix

State : Arizona

Country : United States

City : Beverly Hills

State : California

Country : United States

City : Spring Valley

State : California

Country : United States

City : Encinitas

State : California

Country : United States

City : San Diego

State : California

Country : United States

City : Plantation

State : Florida

Country : United States

City : North Miami Beach

State : Florida

Country : United States

City : Longwood

State : Florida

Country : United States

City : Chicago

State : Illinois

Country : United States

City : Shreveport

State : Louisiana

Country : United States

City : Boston

State : Massachusetts

Country : United States

City : Berlin

State : New Jersey

Country : United States

City : Beth Page

State : New York

Country : United States

City : Tonawanda

State : New York

Country : United States

City : Charlotte

State : North Carolina

Country : United States

City : Dayton

State : Ohio

Country : United States

City : Sellersville

State : Pennsylvania

Country : United States

City : Allentown

State : Pennsylvania

Country : United States

City : Greer

State : South Carolina

Country : United States

City : Spokane

State : Washington

Country : United States

OutComes

Primary OutComes

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