Neurotropin to Treat Acute Dental and Chronic
Neural Pain
Sponsored by the National Institute of Dental and Craniofacial
Research (NIDCR)
Purpose: This study will examine the effectiveness of the
drug neurotropin in treating acute pain after tooth extraction
and chronic pain after injury to a limb or a large nerve.
Three groups of patients will participate in this study: 1)
dental patients undergoing removal of impacted third molars
(wisdom teeth); 2) patients with chronic regional pain syndrome
type 1, or CRPS-I (also called reflex sympathetic dystrophy);
and 3) patients with chronic regional pain syndrome type 2,
or CRPS-II. CRPS-I is pain that develops after relatively
minor injury to an arm or leg, but lasts much longer and is
much more severe than would normally be expected. CRPS-II
is pain resulting from injury to a large nerve.
Candidates
will have a history and physical examination, blood tests,
electrocardiogram and, for dental patients, oral examination
and dental X-rays to confirm the need for third molar extraction.
Participants will undergo the following tests and procedures:
Patients with CRPS I and II will receive an individualized
regimen of physical therapy and standard treatment to control
their pain. In addition, they will receive neutropin or placebo
tablets for 5 weeks, then no trial medicine for at least 1
week, and then the other trial drug for the next 5 weeks.
That is, patients who took placebo the first 5 weeks will
take neutropin the second 5 weeks and vice versa. Neither
the patients nor the doctors will know who received which
drug during the two intervals until the study is over. Patients
will complete questionnaires about their pain, quality of
life, and ability to perform daily living activities. They
will have various tests to measure pain (such as sensitivity
to heat and cold, to an electric current, to a mild pin prick,
etc.); to provide information about changes in their condition
(such as tests of range of motion of joints and limb size);
to measure blood circulation and sweating in the arm or leg
(such as measurements of blood flow to the limb, skin temperature,
and sweat production), and other procedures.
Contact:
National Institute of Dental And Craniofacial Research (NIDCR)
9000 Rockville Pike
Bethesda, Maryland 20892
United States
Patient Recruitment and Public Liaison Office
1-800-411-1222
TTY 1-866-411-1010
prpl@mail.cc.nih.gov
Updated August 11, 2008 |
