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

Durect

Status and phase: Completed; Phase 2

Conditions: Chronic Low Back Pain

Treatments: Drug: Bupivacaine TTS (Bupivacaine Patch); Drug: Placebo patch

Study type: Interventional

Funder types: Industry

Identifiers

NCT01096966

K843-09-2001

Details and patient eligibility

About

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

Enrollment: 263 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

263 participants in 2 patient groups, including a placebo group

Bupivacaine TTS

Experimental group

Treatment:

Drug: Bupivacaine TTS (Bupivacaine Patch)

Placebo patch

Placebo Comparator group

Treatment:

Drug: Placebo patch