Study of the Efficacy and Safety of Bupivacaine TTS Patch in Patients With Chronic Low Back Pain
Primary Purpose
Chronic Low Back Pain
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Bupivacaine TTS (Bupivacaine Patch)
Placebo patch
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Low Back Pain focused on measuring chronic low back pain
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Bupivacaine TTS
Placebo patch
Arm Description
Outcomes
Primary Outcome Measures
Mean change from baseline to 12 weeks in pain in the last 24 hours (daily scores averaged over 14 days)
Secondary Outcome Measures
Subjects achieving 20% pain relief at 12 weeks compared to baseline
Subjects 'much improved' or 'very much improved' at 12 weeks
Full Information
NCT ID
NCT01096966
First Posted
March 30, 2010
Last Updated
June 13, 2022
Sponsor
Durect
Collaborators
Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT01096966
Brief Title
Study of the Efficacy and Safety of Bupivacaine TTS Patch in Patients With Chronic Low Back Pain
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Durect
Collaborators
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain
Keywords
chronic low back pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
263 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bupivacaine TTS
Arm Type
Experimental
Arm Title
Placebo patch
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Bupivacaine TTS (Bupivacaine Patch)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo patch
Intervention Description
Identical in size and shape to the Bupivacaine Patch. Three patches applied to the lower back every 72 hours for 12 weeks.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Subjects achieving 20% pain relief at 12 weeks compared to baseline
Time Frame
baseline to 12 weeks after baseline
Title
Subjects 'much improved' or 'very much improved' at 12 weeks
Time Frame
12 weeks after baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Meisner, PharmD
Organizational Affiliation
King Pharmaceuticals is now a wholly owned subsidiary of Pfizer
Official's Role
Study Director
Facility Information:
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85283
Country
United States
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33306
Country
United States
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32605
Country
United States
City
Longwood
State/Province
Florida
ZIP/Postal Code
32779
Country
United States
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30265
Country
United States
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01103
Country
United States
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10004
Country
United States
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73109
Country
United States
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
City
Altoona
State/Province
Pennsylvania
ZIP/Postal Code
16602
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19139
Country
United States
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
12. IPD Sharing Statement
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Study of the Efficacy and Safety of Bupivacaine TTS Patch in Patients With Chronic Low Back Pain
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