NCT01096966

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 263 (actual)
• Sponsor: Durect · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Chronic Low Back Pain

Interventions

Type	Name	Description
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.
DRUG	Placebo patch	Identical in size and shape to the Bupivacaine Patch. Three patches applied to the lower back every 72 hours for 12 weeks.

Timeline

• Start date: 2010-03-01
• Primary completion: 2011-02-01
• Completion: 2011-02-01
• First posted: 2010-03-31
• Last updated: 2022-06-15

Locations

21 sites across 1 country: United States