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

Overview

This study will evaluate the efficacy and safety of Bupivacaine TTS (Bupivacaine patch) compared to placebo in patients with chronic low back pain.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: February 2011

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: Bupivacaine TTS
  • Placebo Comparator: Placebo patch

Clinical Trial Outcome Measures

Primary Measures

  • Mean change from baseline to 12 weeks in pain in the last 24 hours (daily scores averaged over 14 days)
    • Time Frame: baseline to 12 weeks after baseline

Secondary Measures

  • Subjects achieving 20% pain relief at 12 weeks compared to baseline
    • Time Frame: baseline to 12 weeks after baseline
  • Subjects ‘much improved’ or ‘very much improved’ at 12 weeks
    • Time Frame: 12 weeks after baseline

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Durect
  • Collaborator
    • Pfizer
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Paul Meisner, PharmD, Study Director, King Pharmaceuticals is now a wholly owned subsidiary of Pfizer

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