Clinical trial NCT01096966: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Low Back Pain
Keywords: chronic low back pain
Lead sponsor: Durect
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2010-03-31
Enrollment: 263
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Mean change from baseline to 12 weeks in pain in the last 24 hours (daily scores averaged over 14 days)
timeFrame: baseline to 12 weeks after baseline
Secondary outcomes:
measure: Subjects achieving 20% pain relief at 12 weeks compared to baseline
timeFrame: baseline to 12 weeks after baseline
measure: Subjects 'much improved' or 'very much improved' at 12 weeks
timeFrame: 12 weeks after baseline
Other outcomes:
Locations:
city: Tempe
country: United States
state: Arizona
city: La Mesa
country: United States
state: California
city: Torrance
country: United States
state: California
city: Fort Lauderdale
country: United States
state: Florida
city: Gainesville
country: United States
state: Florida
city: Longwood
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Marietta
country: United States
state: Georgia
city: Newnan
country: United States
state: Georgia
city: Springfield
country: United States
state: Massachusetts
city: Saint Louis
country: United States
state: Missouri
city: New York
country: United States
state: New York
city: Winston-Salem
country: United States
state: North Carolina
city: Oklahoma City
country: United States
state: Oklahoma
city: Allentown
country: United States
state: Pennsylvania
city: Altoona
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Austin
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Richmond
country: United States
state: Virginia
Study officials:
affiliation: King Pharmaceuticals is now a wholly owned subsidiary of Pfizer
name: Paul Meisner, PharmD
role: STUDY_DIRECTOR
References: