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

Condition(s) targeted: Chronic Low Back Pain

Intervention: Bupivacaine TTS (Bupivacaine Patch) (Drug); Placebo patch (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: King Pharmaceuticals Research and Development

Official(s) and/or principal investigator(s):
Paul Meisner, PharmD, Study Director, Affiliation: King Pharmaceuticals Research and Development

Overall contact:
Shawn Trutna, Phone: 919-674-0110, Email: shawn.trutna@wwctrials.com

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

Official 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

Study design: Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Mean change from baseline to 12 weeks in pain in the last 24 hours (daily scores averaged over 14 days)

Secondary outcome:

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

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

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

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

Shawn Trutna, Phone: 919-674-0110, Email: shawn.trutna@wwctrials.com

Tempe, Arizona 85283, United States; Recruiting

LaMesa, California 91942, United States; Recruiting

Torrance, California 90502, United States; Recruiting

Ft. Lauderdale, Florida 33306, United States; Recruiting

Gainesville, Florida 32605, United States; Recruiting

Longwood, Florida 32779, United States; Recruiting

West Palm Beach, Florida 33409, United States; Recruiting

Marietta, Georgia 30060, United States; Recruiting

Newnan, Georgia 30265, United States; Recruiting

Springfield, Massachusetts 01103, United States; Recruiting

St. Louis, Missouri 63141, United States; Recruiting

New York, New York 10004, United States; Recruiting

Winston-Salem, North Carolina 27103, United States; Recruiting

Oklahoma City, Oklahoma 73109, United States; Recruiting

Allentown, Pennsylvania 18103, United States; Recruiting

Altoona, Pennsylvania 16602, United States; Recruiting

Philadelphia, Pennsylvania 19139, United States; Recruiting

Austin, Texas 78756, United States; Recruiting

Dallas, Texas 75231, United States; Recruiting

Houston, Texas 77074, United States; Recruiting

Richmond, Virginia 23294, United States; Recruiting

Starting date: March 2010
Last updated: September 28, 2010