Chronic Low Back Pain
Conditions
Keywords
chronic low back pain
Brief summary
This study will evaluate the efficacy and safety of Bupivacaine TTS (Bupivacaine patch) compared to placebo in patients with chronic low back pain.
Interventions
DRUGBupivacaine TTS (Bupivacaine Patch)
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.
DRUGPlacebo patch
Identical in size and shape to the Bupivacaine Patch. Three patches applied to the lower back every 72 hours for 12 weeks.
Sponsors
Pfizer
Durect
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Diagnosis of chronic low back pain for more than 3 months 2. 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 3. Pain intensity score greater than or equal to 5 out of 10 at the first visit 4. Able to apply patches at home 5. Able and willing to complete daily pain intensity ratings using an electronic diary device for the duration of the study 6. Females of childbearing potential must agree to use a medically acceptable method of contraception throughout the study
Exclusion criteria
1. History of, or ongoing, alcohol or drug abuse 2. Positive drug test for alcohol, illicit drug use or opioids 3. Primary diagnosis of chronic low back pain due to neuropathic pain 4. History of back surgery or plan for back surgery 5. Use of opioids within 2 weeks of the first visit and during the study 6. Previous ineffective use of lidocaine patches 7. Morbid obesity 8. Moderate or severe depression 9. An open skin lesion within the painful area where patches will be applied 10. Patients with active or resolved back pain litigation or receiving disability payments due to chronic low back pain 11. Pregnant or breastfeeding females
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
United States
Outcome results
None listed