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

This study has been completed.
Sponsor:
Collaborator:
Durect Corporation
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01096966
First received: March 30, 2010
Last updated: May 24, 2012
Last verified: August 2011
  Purpose

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


Condition Intervention Phase
Chronic Low Back Pain
Drug: Bupivacaine TTS (Bupivacaine Patch)
Drug: Placebo patch
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Subjects achieving 20% pain relief at 12 weeks compared to baseline [ Time Frame: baseline to 12 weeks after baseline ] [ Designated as safety issue: No ]
  • Subjects 'much improved' or 'very much improved' at 12 weeks [ Time Frame: 12 weeks after baseline ] [ Designated as safety issue: No ]

Enrollment: 263
Study Start Date: March 2010
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01096966

Locations
United States, Arizona
Tempe, Arizona, United States, 85283
United States, California
LaMesa, California, United States, 91942
Torrance, California, United States, 90502
United States, Florida
Ft. Lauderdale, Florida, United States, 33306
Gainesville, Florida, United States, 32605
Longwood, Florida, United States, 32779
West Palm Beach, Florida, United States, 33409
United States, Georgia
Marietta, Georgia, United States, 30060
Newnan, Georgia, United States, 30265
United States, Massachusetts
Springfield, Massachusetts, United States, 01103
United States, Missouri
St. Louis, Missouri, United States, 63141
United States, New York
New York, New York, United States, 10004
United States, North Carolina
Winston-Salem, North Carolina, United States, 27103
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73109
United States, Pennsylvania
Allentown, Pennsylvania, United States, 18103
Altoona, Pennsylvania, United States, 16602
Philadelphia, Pennsylvania, United States, 19139
United States, Texas
Austin, Texas, United States, 78756
Dallas, Texas, United States, 75231
Houston, Texas, United States, 77074
United States, Virginia
Richmond, Virginia, United States, 23294
Sponsors and Collaborators
Pfizer
Durect Corporation
Investigators
Study Director: Paul Meisner, PharmD King Pharmaceuticals is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01096966     History of Changes
Other Study ID Numbers: K843-09-2001
Study First Received: March 30, 2010
Last Updated: May 24, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
chronic low back pain

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 14, 2014