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

June 13, 2022 updated by: Durect

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

263

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tempe, Arizona, United States, 85283
    • California
      • La Mesa, California, United States, 91942
      • Torrance, California, United States, 90502
    • Florida
      • Fort Lauderdale, Florida, United States, 33306
      • Gainesville, Florida, United States, 32605
      • Longwood, Florida, United States, 32779
      • West Palm Beach, Florida, United States, 33409
    • Georgia
      • Marietta, Georgia, United States, 30060
      • Newnan, Georgia, United States, 30265
    • Massachusetts
      • Springfield, Massachusetts, United States, 01103
    • Missouri
      • Saint Louis, Missouri, United States, 63141
    • New York
      • New York, New York, United States, 10004
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73109
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
      • Altoona, Pennsylvania, United States, 16602
      • Philadelphia, Pennsylvania, United States, 19139
    • Texas
      • Austin, Texas, United States, 78756
      • Dallas, Texas, United States, 75231
      • Houston, Texas, United States, 77074
    • Virginia
      • Richmond, Virginia, United States, 23294

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo patch
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.
Experimental: Bupivacaine TTS
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean change from baseline to 12 weeks in pain in the last 24 hours (daily scores averaged over 14 days)
Time Frame: baseline to 12 weeks after baseline
baseline to 12 weeks after baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
Subjects achieving 20% pain relief at 12 weeks compared to baseline
Time Frame: baseline to 12 weeks after baseline
baseline to 12 weeks after baseline
Subjects 'much improved' or 'very much improved' at 12 weeks
Time Frame: 12 weeks after baseline
12 weeks after baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Durect

Collaborators

Pfizer

Investigators

  • Study Director: Paul Meisner, PharmD, King Pharmaceuticals is now a wholly owned subsidiary of Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

March 30, 2010

First Submitted That Met QC Criteria

March 30, 2010

First Posted (Estimate)

March 31, 2010

Study Record Updates

Last Update Posted (Actual)

June 15, 2022

Last Update Submitted That Met QC Criteria

June 13, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K843-09-2001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Low Back Pain

Clinical Trials on Bupivacaine TTS (Bupivacaine Patch)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Thailand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe