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

Last updated on August 9, 2018

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.
Show details

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

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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
This study will evaluate the efficacy and safety of Bupivacaine TTS (Bupivacaine patch) compared to placebo in patients with chronic low back pain.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Chronic Low Back Pain
  • Drug: 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.
  • Drug: Placebo patch
    Identical in size and shape to the Bupivacaine Patch. Three patches applied to the lower back every 72 hours for 12 weeks.
  • Experimental: Bupivacaine TTS
    Intervention: Drug: Bupivacaine TTS (Bupivacaine Patch)
  • Placebo Comparator: Placebo patch
    Intervention: Drug: Placebo patch
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
263
February 2011
February 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01096966
K843-09-2001
No
Not Provided
Not Provided
Pfizer
Pfizer
Durect
Study Director: Paul Meisner, PharmD King Pharmaceuticals is now a wholly owned subsidiary of Pfizer
Pfizer
August 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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