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

Durect0 sites263 target enrollmentMarch 2010

Overview

Phase: Phase 2
Intervention: Bupivacaine TTS (Bupivacaine Patch)
Conditions: Chronic Low Back Pain
Sponsor: Durect
Enrollment: 263
Primary Endpoint: Mean change from baseline to 12 weeks in pain in the last 24 hours (daily scores averaged over 14 days)
Status: Completed
Last Updated: 3 years ago

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

Registry

clinicaltrials.gov

Start Date

March 2010

End Date

February 2011

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

Responsible Party

Sponsor

•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

•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

Intervention: Bupivacaine TTS (Bupivacaine Patch)

Intervention: Placebo patch

Mean change from baseline to 12 weeks in pain in the last 24 hours (daily scores averaged over 14 days)

Time Frame: baseline to 12 weeks after baseline

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)