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

Last updated on February 20, 2019

FOR MORE INFORMATION
Study Location
Tempe, Arizona, 85283 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Chronic Low Back Pain
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-70 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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

NCT01096966
Pfizer
Completed
Study of the Efficacy and Safety of Bupivacaine TTS Patch in Patients With Chronic Low Back Pain

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now