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

TerminatedPhase 4NCT00904397
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study 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
Sponsor
Endo USA Inc., a Keenova Therapeutics Company
Start date
2004-07
Primary completion
2004-11
Sex
All
Age range
from 18 Years
Results posted
No results posted in this snapshot
Countries
United States
Total sites listed
21

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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 rece…

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00904397