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

NCT01096966 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 263

Last updated 2022-06-15

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Durect

    lead INDUSTRY

Principal Investigators

  • Paul Meisner, PharmD · King Pharmaceuticals is now a wholly owned subsidiary of Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2011-02-28
Completion
2011-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01096966 on ClinicalTrials.gov