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Completed

NCT Number: NCT01096966

Study of the Efficacy and Safety of Bupivacaine TTS 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.

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Key information

Conditions

Chronic Low Back Pain

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Tempe, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of chronic low back pain for more than 3 months
  • 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
  • Pain intensity score greater than or equal to 5 out of 10 at the first visit
  • Able to apply patches at home
  • Able and willing to complete daily pain intensity ratings using an electronic diary device for the duration of the study
  • Females of childbearing potential must agree to use a medically acceptable method of contraception throughout the study

Exclusion criteria

  • History of, or ongoing, alcohol or drug abuse
  • Positive drug test for alcohol, illicit drug use or opioids
  • Primary diagnosis of chronic low back pain due to neuropathic pain
  • History of back surgery or plan for back surgery
  • Use of opioids within 2 weeks of the first visit and during the study
  • Previous ineffective use of lidocaine patches
  • Morbid obesity
  • Moderate or severe depression
  • An open skin lesion within the painful area where patches will be applied
  • Patients with active or resolved back pain litigation or receiving disability payments due to chronic low back pain
  • Pregnant or breastfeeding females

Treatment and study plan

Bupivacaine TTS (Bupivacaine Patch)

Drug

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.

Placebo Patch

Drug

Identical in size and shape to the Bupivacaine Patch. Three patches applied to the lower back every 72 hours for 12 weeks.

Primary outcomes

  1. 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 outcomes

  1. Subjects achieving 20% pain relief at 12 weeks compared to baseline

    Time frame: baseline to 12 weeks after baseline

  2. Subjects 'much improved' or 'very much improved' at 12 weeks

    Time frame: 12 weeks after baseline

Sponsors and collaborators

Lead sponsor

Durect

Industry

Collaborators

  • Pfizer

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Mar 31, 2010
Registry last updated
Jun 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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