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

Chronic Low Back Pain Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00904397
• Other study ID #: EN3220-013
• Status: Terminated
• Phase: Phase 4
• First received: May 15, 2009
• Last updated: February 12, 2010
• Start date: July 2004

Study information

• Verified date: February 2010
• Source: Endo Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 98
• Est. primary completion date: November 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Endo Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	Patient'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)	No
Secondary	Investigator's Global Assessment of Treatment Satisfaction 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)	No
Secondary	Patient's Global Assessment of Treatment Satisfaction 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)	No
Secondary	Safety assessments included AEs (including discontinuation due to AEs).		Visit - V2 (Day 0), V3 (Day 14), V4 (Day 28), V5 (Day 42), V6 (Day 56), V7 (Day 84)	Yes
Secondary	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.		Visit - V2 (Day 0), V3 (Day 14), V4 (Day 28), V5 (Day 42), V6 (Day 56), V7 (Day 84)	Yes
Secondary	Safety assessments included plasma lidocaine concentrations (lidocaine group only).		Visit - V2 (Day 0), V3 (Day 14), V4 (Day 28), V5 (Day 42), V6 (Day 56), V7 (Day 84)	Yes