Lidocaine Patch 5% Versus Celecoxib 200 mg in Chronic Axial Low Back Pain
Information source: Endo Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Low Back Pain
Intervention: Lidoderm® (Drug); Celecoxib (Drug)
Phase: Phase 4
Status: Terminated
Sponsored by: Endo Pharmaceuticals Official(s) and/or principal investigator(s): Sr. Director, Study Director, Affiliation: Endo Pharmaceuticals
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Mean change from baseline to Week 12 in BPI average pain intensity score (Question 5).
Secondary outcome: 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 BPIMean change from baseline to Weeks 2, 4, 6, 8, and 12 in BPI pain relief score (Question 8). Mean change from baseline to Weeks 2, 4, 6, 8, and 12 in PQAS composite scores Mean change from baseline to Weeks 2, 4, 6, 8, and 12 in Oswestry Disability Index composite scores Investigator's Global Impression of Change in LBP at Week 12 (or premature discontinuation) Patient's Global Impression of Change in LBP at Week 12 (or premature discontinuation) Investigator's Global Assessment of Treatment Satisfaction at Week 12 (or premature discontinuation) Patient's Global Assessment of Treatment Satisfaction at Week 12 (or premature discontinuation) Safety assessments included AEs (including discontinuation due to AEs). 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. Safety assessments included plasma lidocaine concentrations (lidocaine group only).
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
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
Beth Page, 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
Additional Information
Starting date: July 2004
Last updated: February 12, 2010
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