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

CompletedPhase 2

Sponsor: Durect

Conditions: Chronic Low Back Pain

Interventions: Bupivacaine TTS (Bupivacaine Patch), Placebo patch

Countries: United States

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

Eligibility overview

Sex: ALL

Age: 18 Years to 70 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (21)

Tempe, Arizona, United States
La Mesa, California, United States
Torrance, California, United States
Fort Lauderdale, Florida, United States
Gainesville, Florida, United States
Longwood, Florida, United States
West Palm Beach, Florida, United States
Marietta, Georgia, United States
Newnan, Georgia, United States
Springfield, Massachusetts, United States
St Louis, Missouri, United States
New York, New York, United States
Winston-Salem, North Carolina, United States
Oklahoma City, Oklahoma, United States
Allentown, Pennsylvania, United States
Altoona, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Austin, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
Richmond, Virginia, United States