Study of the Efficacy and Safety of Bupivacaine TTS Patch in Patients With Chronic Low Back Pain
NCT ID: NCT01096966
Last Updated: 2022-06-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
263 participants
INTERVENTIONAL
2010-03-31
2011-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Bupivacaine TTS
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 patch
Placebo patch
Identical in size and shape to the Bupivacaine Patch. Three patches applied to the lower back every 72 hours for 12 weeks.
Interventions
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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 patch
Identical in size and shape to the Bupivacaine Patch. Three patches applied to the lower back every 72 hours for 12 weeks.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
70 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Durect
INDUSTRY
Responsible Party
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Principal Investigators
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Paul Meisner, PharmD
Role: STUDY_DIRECTOR
King Pharmaceuticals is now a wholly owned subsidiary of Pfizer
Locations
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Tempe, Arizona, United States
La Mesa, California, United States
Torrance, California, United States
Fort Lauderdale, Florida, United States
Gainesville, Florida, United States
Longwood, Florida, United States
West Palm Beach, Florida, United States
Marietta, Georgia, United States
Newnan, Georgia, United States
Springfield, Massachusetts, United States
St Louis, Missouri, United States
New York, New York, United States
Winston-Salem, North Carolina, United States
Oklahoma City, Oklahoma, United States
Allentown, Pennsylvania, United States
Altoona, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Austin, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
Richmond, Virginia, United States
Countries
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Other Identifiers
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K843-09-2001
Identifier Type: -
Identifier Source: org_study_id
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