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
1 other identifier
interventional
263
1 country
21
Brief Summary
This study will evaluate the efficacy and safety of Bupivacaine TTS (Bupivacaine patch) compared to placebo in patients with chronic low back pain.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2010
Shorter than P25 for phase_2
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 30, 2010
CompletedFirst Posted
Study publicly available on registry
March 31, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2011
CompletedJune 15, 2022
June 1, 2022
11 months
March 30, 2010
June 13, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean change from baseline to 12 weeks in pain in the last 24 hours (daily scores averaged over 14 days)
baseline to 12 weeks after baseline
Secondary Outcomes (2)
Subjects achieving 20% pain relief at 12 weeks compared to baseline
baseline to 12 weeks after baseline
Subjects 'much improved' or 'very much improved' at 12 weeks
12 weeks after baseline
Study Arms (2)
Bupivacaine TTS
EXPERIMENTALPlacebo patch
PLACEBO COMPARATORInterventions
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.
Identical in size and shape to the Bupivacaine Patch. Three patches applied to the lower back every 72 hours for 12 weeks.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
Unknown Facility
Tempe, Arizona, 85283, United States
Unknown Facility
La Mesa, California, 91942, United States
Unknown Facility
Torrance, California, 90502, United States
Unknown Facility
Fort Lauderdale, Florida, 33306, United States
Unknown Facility
Gainesville, Florida, 32605, United States
Unknown Facility
Longwood, Florida, 32779, United States
Unknown Facility
West Palm Beach, Florida, 33409, United States
Unknown Facility
Marietta, Georgia, 30060, United States
Unknown Facility
Newnan, Georgia, 30265, United States
Unknown Facility
Springfield, Massachusetts, 01103, United States
Unknown Facility
St Louis, Missouri, 63141, United States
Unknown Facility
New York, New York, 10004, United States
Unknown Facility
Winston-Salem, North Carolina, 27103, United States
Unknown Facility
Oklahoma City, Oklahoma, 73109, United States
Unknown Facility
Allentown, Pennsylvania, 18103, United States
Unknown Facility
Altoona, Pennsylvania, 16602, United States
Unknown Facility
Philadelphia, Pennsylvania, 19139, United States
Unknown Facility
Austin, Texas, 78756, United States
Unknown Facility
Dallas, Texas, 75231, United States
Unknown Facility
Houston, Texas, 77074, United States
Unknown Facility
Richmond, Virginia, 23294, United States
Study Officials
- STUDY DIRECTOR
Paul Meisner, PharmD
King Pharmaceuticals is now a wholly owned subsidiary of Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 30, 2010
First Posted
March 31, 2010
Study Start
March 1, 2010
Primary Completion
February 1, 2011
Study Completion
February 1, 2011
Last Updated
June 15, 2022
Record last verified: 2022-06