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

Chronic Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01096966
• Other study ID #: K843-09-2001
• Status: Completed
• Phase: Phase 2
• Start date: March 2010
• Est. completion date: February 2011

Study information

• Verified date: June 2022
• Source: Durect
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 263
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

Drug:
• Bupivacaine 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.
• Placebo patch
Identical in size and shape to the Bupivacaine Patch. Three patches applied to the lower back every 72 hours for 12 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Durect	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Subjects achieving 20% pain relief at 12 weeks compared to baseline		baseline to 12 weeks after baseline
Secondary	Subjects 'much improved' or 'very much improved' at 12 weeks		12 weeks after baseline