Study of the Efficacy and Safety of Bupivacaine TTS Patch in Patients With Chronic Low Back Pain

Study Overview
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Brief Summary
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This study will evaluate the efficacy and safety of Bupivacaine TTS (Bupivacaine patch) compared to placebo in patients with chronic low back pain.

Official Title
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A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Bupivacaine TTS (Bupivacaine Patch) in Patients With Chronic Low Back Pain

Conditions
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Chronic Low Back Pain

Intervention / Treatment
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* Drug: Bupivacaine TTS (Bupivacaine Patch)
* Drug: Placebo patch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of chronic low back pain for more than 3 months If taking non-steroidal anti-inflammatory drugs or non-opioid analgesics, must be on a regular, scheduled dose for at least 4 weeks prior to the first visit and intend to remain on a stable dose of these agents for the study duration Pain intensity score greater than or equal to 5 out of 10 at the first visit Able to apply patches at home Able and willing to complete daily pain intensity ratings using an electronic diary device for the duration of the study Females of childbearing potential must agree to use a medically acceptable method of contraception throughout the study Exclusion Criteria: History of, or ongoing, alcohol or drug abuse Positive drug test for alcohol, illicit drug use or opioids Primary diagnosis of chronic low back pain due to neuropathic pain History of back surgery or plan for back surgery Use of opioids within 2 weeks of the first visit and during the study Previous ineffective use of lidocaine patches Morbid obesity Moderate or severe depression An open skin lesion within the painful area where patches will be applied Patients with active or resolved back pain litigation or receiving disability payments due to chronic low back pain Pregnant or breastfeeding females

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bupivacaine TTS<br> | Drug: Bupivacaine TTS (Bupivacaine Patch)<br>* Contains bupivacaine base, in a flexible and rectangular-shaped, transdermal, delivery system. Three patches applied to the lower back every 72 hours for 12 weeks.<br>|
| Placebo Comparator: Placebo patch<br> | Drug: Placebo patch<br>* Identical in size and shape to the Bupivacaine Patch. Three patches applied to the lower back every 72 hours for 12 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline to 12 weeks in pain in the last 24 hours (daily scores averaged over 14 days) |  | baseline to 12 weeks after baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjects achieving 20% pain relief at 12 weeks compared to baseline |  | baseline to 12 weeks after baseline | 
| Subjects 'much improved' or 'very much improved' at 12 weeks |  | 12 weeks after baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic low back pain