Acute and Chronic Non-radicular LBP Clinical Trial
Official title:
Open-Label Study Assessing the Efficacy of Topical Lidocaine Patch in Treatment of Low Back Pain
NCT number | NCT00904540 |
Other study ID # | EN3220-006 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | March 2002 |
Verified date | December 2023 |
Source | Endo Pharmaceuticals |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Patients with acute or chronic Lower Back Pain (LBP) participated in a Phase IV clinical trial to assess the effectiveness of Lidoderm administered once daily (q24h) for 2 weeks in the treatment of acute and chronic LBP.
Status | Completed |
Enrollment | 131 |
Est. completion date | |
Est. primary completion date | October 2002 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Non-radicular LBP pain for =12 months (non-radicular defined as LBP that does not radiate below the mid-buttock and with no sensory symptoms in the leg) - Had LBP as the primary source of pain. Patients may have had mild to moderate spinal stenosis and no radicular symptoms - Had an average daily pain intensity score of >4 on a 0 to 10 scale, with 0 being no pain and 10 being pain as bad as the patients have ever imagined (Question 5 of BPI) within 24 hours prior to the screening visit. - Had a normal neurological examination, including: - Motor strength - Sensory testing (light touch, pinprick, and vibration) - Deep tendon reflexes Patients were eligible for participation in the long-term chronic (>12 months) group of the study if they also: - Had LBP for greater than one year. Patients may have had any of the following: lumbar degenerative disc disease, internal disc disruption, mild-to-severe spinal stenosis, degenerative scoliosis and spondylolisthesis, facet arthropathy Exclusion Criteria: - Had a history of greater than one back surgery or one back surgery within 3 months of study entry - Had severe spinal stenosis and radicular symptoms - Had any other chronic pain condition that, in the opinion of the investigator, would have interfered with patient assessment of LBP relief - Had received an epidural steroid/local anesthetic injection within 2 weeks prior to study entry - Had received trigger point injections within 2 weeks prior to study entry - Had received Botox Injections within 3 months prior to study entry - Were taking a lidocaine-containing product that could not be discontinued while receiving Lidoderm - Were taking class 1 anti-arrhythmic drugs (e.g., mexiletine, tocainide) Patients were excluded from participation in the long-term chronic (>12 months) group if they also: - Had an undefined spinal diagnosis - Had a history of lumbar spine surgery within 6 months prior to study entry |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Endo Pharmaceuticals |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean change in average daily intensity (Question 5 of Brief Pain Inventory [BPI] Questionnaire) from baseline to Week 2 | Visits - V2 (Day 0), V3 (Day 7), V4 (Day 14), V5 (Day 28), V6/EOS (Day 42) | ||
Secondary | Mean change from baseline to Week 6 in average pain intensity (Question 5 of the BPI) | Visits - V2 (Day 0), V3 (Day 7), V4 (Day 14), V5 (Day 28), V6/EOS (Day 42) | ||
Secondary | Mean change from baseline to Week 2 and to Week 6 in Neuropathic Pain Scale (NPS) composite scores | Visits - V2 (Day 0), V3 (Day 7), V4 (Day 14), V5 (Day 28), V6/EOS (Day 42) | ||
Secondary | QOL: change from baseline to Week 2 to Week 6 in Question 9 of the BPI, in Beck Depression Inventory Questionnaire, and the Patient and Investigator Global Assessment of Patch Satisfaction and Pain Relief | Visits - V2 (Day 0), V3 (Day 7), V4 (Day 14), V5 (Day 28), V6/EOS (Day 42) | ||
Secondary | Safety assessments include AEs, clinical laboratory tests, vital signs, physical/neurological examinations, and dermal/sensory assessments. | Visits - V2 (Day 0), V3 (Day 7), V4 (Day 14), V5 (Day 28), V6/EOS (Day 42) |