UTHCT seeking people with chronic low back pain for clinical study of new medication

Monday, May 8, 2006

As many as 85 percent of Americans suffer from low back pain, and many of them can’t find effective treatments for their condition. New drugs designed to alleviate their pain may be one answer, and The University of Texas Health Science Center at Tyler has joined a study of one such drug.

The drug, bicifadine, is made by DOV Pharmaceutical, Inc., said James McKinley, MD, a family medicine physician and UTHSCT’s principal investigator for the study. Bicifadine is a non-narcotic drug and an investigational medication – the U.S. Food and Drug Administration has not yet approved it.

“The lower back is an area that tends to wear out over time. Historically, people have not exercised their core body muscles through strength training, which would help give the lower back more support,” he said.

In this study, bicifadine is being given to a large number of people to make sure it is both safe and effective, Dr. McKinley said. This is the last stage of the clinical trial process. After the study ends, the FDA will evaluate the results and decide whether to approve bicifadine.

“This is another effort to find a non-narcotic medication that works to end low back pain. People develop tolerance to narcotics and, over time, have to increase the dosage to decrease the pain. And there is the possibility a patient might eventually become addicted to the narcotic,” Dr. McKinley said.

Bicifadine affects the neurotransmitters, chemicals that allow the movement of information from one neuron, or nerve cell, to another, he said. The drug works in the brain and on the nerves to modulate the pain signal.

To be eligible for this study, individuals must be at least 18 years of age and have had chronic lower back pain for three months or more. Chronic back pain must be a primary problem for them, Dr. McKinley said. Participants will not be allowed to continue taking other back pain medications during the 12-week-long study.

Participants will receive all study-related medications, tests, exams, and study-related care from board certified physicians at no charge. This is a randomized study, which means participants will either receive the investigational drug or a placebo. Neither physicians nor participants will know who is getting the new drug and who the placebo. UTHSCT is the only site in East Texas and one of just 60 sites in the United States taking part in this study.

“The primary objective of the study is to determine if bicifadine reduces participants’ lower back pain and helps improve their quality of life,” Dr. McKinley said.

For more information about this study, call the Center for Clinical Research at (903) 877-7753.

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