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

NCT01096966

Last updated date
Study Location
Tempe, Arizona, 85283, United States
Contact
1-800-718-1021

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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

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Chronic Low Back PainStudy of the Efficacy and Safety of Bupivacaine TTS Patch in Patients With Chronic Low Back Pain
NCT01096966
  1. Tempe, Arizona
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  3. Torrance, California
  4. Ft. Lauderdale, Florida
  5. Gainesville, Florida
  6. Longwood, Florida
  7. West Palm Beach, Florida
  8. Marietta, Georgia
  9. Newnan, Georgia
  10. Springfield, Massachusetts
  11. St. Louis, Missouri
  12. New York, New York
  13. Winston-Salem, North Carolina
  14. Oklahoma City, Oklahoma
  15. Allentown, Pennsylvania
  16. Altoona, Pennsylvania
  17. Philadelphia, Pennsylvania
  18. Austin, Texas
  19. Dallas, Texas
  20. Houston, Texas
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Chronic Low Back PainPF-06372865 In Subjects With Chronic Low Back Pain
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  1. Mesa, Arizona
  2. Phoenix, Arizona
  3. Anaheim, California
  4. Fresno, California
  5. North Hollywood, California
  6. Wildomar, California
  7. Stamford, Connecticut
  8. DeLand, Florida
  9. Fort Lauderdale, Florida
  10. Gainesville, Florida
  11. Hollywood, Florida
  12. Jacksonville, Florida
  13. Orlando, Florida
  14. Pembroke Pines, Florida
  15. Port Orange, Florida
  16. South Miami, Florida
  17. South Miami, Florida
  18. Atlanta, Georgia
  19. Blue Ridge, Georgia
  20. Columbus, Georgia
  21. Columbus, Georgia
  22. Marietta, Georgia
  23. Newnan, Georgia
  24. Newnan, Georgia
  25. Savannah, Georgia
  26. Woodstock, Georgia
  27. Woodstock, Georgia
  28. Chicago, Illinois
  29. Lake Charles, Louisiana
  30. Boston, Massachusetts
  31. Methuen, Massachusetts
  32. Jackson, Mississippi
  33. Jackson, Mississippi
  34. Hartsdale, New York
  35. Rochester, New York
  36. Raleigh, North Carolina
  37. Raleigh, North Carolina
  38. Winston-Salem, North Carolina
  39. Portland, Oregon
  40. Duncansville, Pennsylvania
  41. Warwick, Rhode Island
  42. Houston, Texas
  43. San Antonio, Texas
  44. San Antonio, Texas
  45. Norfolk, Virginia
  46. Seattle, Washington
ALL GENDERS
18 Years+
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Advanced Information
Descriptive Information
Brief Title  ICMJE Study of the Efficacy and Safety of Bupivacaine TTS Patch in Patients With Chronic Low Back Pain
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Chronic Low Back Pain
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Bupivacaine TTS
    Intervention: Drug: Bupivacaine TTS (Bupivacaine Patch)
  • Placebo Comparator: Placebo patch
    Intervention: Drug: Placebo patch
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 3, 2011)
263
Original Estimated Enrollment  ICMJE
 (submitted: March 30, 2010)
260
Actual Study Completion Date  ICMJE February 2011
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01096966
Other Study ID Numbers  ICMJE K843-09-2001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Durect
Investigators  ICMJE
Study Director:Paul Meisner, PharmDKing Pharmaceuticals is now a wholly owned subsidiary of Pfizer
PRS Account Pfizer
Verification Date August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP