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

Phase 2

Completed

• Conditions: Chronic Low Back Pain
• Interventions: Drug: Bupivacaine TTS (Bupivacaine Patch); Drug: Placebo patch

• Registration Number: NCT01096966
• Lead Sponsor: Durect

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-03-30
• Study First Submitted QC: 2010-03-30
• Study First Posted: 2010-03-31
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Disposition First Submitted: 2011-08-16
• Disposition First Submitted QC: 2011-08-16
• Disposition First Posted: 2011-08-23
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-13
• Last Update Posted: 2022-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 263

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bupivacaine TTS	Bupivacaine TTS (Bupivacaine Patch)	-
Placebo patch	Placebo patch	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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