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

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:

MedlinePlus related topics: Back Pain

Drug Information available for: Bupivacaine hydrochloride Bupivacaine

U.S. FDA Resources

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:

Diagnosis of chronic low back pain for more than 3 months
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
Pain intensity score greater than or equal to 5 out of 10 at the first visit
Able to apply patches at home
Able and willing to complete daily pain intensity ratings using an electronic diary device for the duration of the study
Females of childbearing potential must agree to use a medically acceptable method of contraception throughout the study

Exclusion Criteria:

History of, or ongoing, alcohol or drug abuse
Positive drug test for alcohol, illicit drug use or opioids
Primary diagnosis of chronic low back pain due to neuropathic pain
History of back surgery or plan for back surgery
Use of opioids within 2 weeks of the first visit and during the study
Previous ineffective use of lidocaine patches
Morbid obesity
Moderate or severe depression
An open skin lesion within the painful area where patches will be applied
Patients with active or resolved back pain litigation or receiving disability payments due to chronic low back pain
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 June 18, 2013