Coral study testing Copaxone by mouth.The first large-scale, controlled, double-blind study double-blind study, n experimental technique in clinical research in which neither the researcher nor the patient knows whether the treatment administered is considered inactive (placebo) or active (medicinal). of Copaxone in tablet form is now under way in 178 centers in 18 countries. There are 57 sites in the U.S. This is the first of the disease-modifying "ABC ABC in full American Broadcasting Co. Major U.S. television network. It began when the expanding national radio network NBC split into the separate Red and Blue networks in 1928. " drugs to be available in oral rather than injectable in·ject·a·ble adj. Capable of being injected. Used of a drug. n. A drug or medicine that can be injected. form, but its effectiveness in people with MS is not yet known. Some 1,300 people are being sought to participate in the "Coral Study", as it has been dubbed dub 1 tr.v. dubbed, dub·bing, dubs 1. To tap lightly on the shoulder by way of conferring knighthood. 2. To honor with a new title or description. 3. by sponsors Teva Marion Partners in Missouri and Teva Pharmaceutical Industries Teva Pharmaceutical Industries Ltd. (Hebrew: טבע תעשיות פרמצבטיות בע"מ), NASDAQ: TEVA is an international pharmaceutical company headquartered in in Israel. Strict enrollment requirements Men and women with clinically definite relapsing-remitting MS, who have had the disease at least 6 months, and who can walk unassisted and without resting for at least 200 meters, are eligible to volunteer. The study requires medically documented evidence of at least one MS attack in the prior year, but no relapses or use of steroids steroids, class of lipids having a particular molecular ring structure called the cyclopentanoperhydro-phenanthrene ring system. Steroids differ from one another in the structure of various side chains and additional rings. during the month just prior to enrollment. People who have used Copaxone by injection can't participate--and people who have used the interferons, either Avonex or Betaseron (or Rebif or Betaferon outside the U.S.), are eligible only if they have been off these drugs for at least 6 months. There are other eligibility requirements as well. Volunteers are expected to continue on the study for 56 weeks (13 months). A special aspect of this study Volunteers should be aware that the Coral Study is a "placebo-controlled" trial. About a third of the people in the study will not receive any real Copaxone at all. They will be randomly chosen to take an inert look-alike, or placebo. Thus, they will not be receiving the benefit of being on one of the A, B, or C drugs known to modify MS. And no one will know who is getting what until the study is complete or stopped. Throughout the study, outcomes will be monitored by an independent international committee for early indications of the success or failure of oral Copaxone. This is a critical protection for the volunteers. Anyone interested in volunteering should discuss the study--and this aspect of it--with their personal physician. For the location of the study sites, to prescreen pre·screen tr.v. pre·screened, pre·screen·ing, pre·screens 1. To view (a movie) before release for public showing. 2. for the study, or for more information, call toll-free at 1-877-31CORAL (1-877-312-6725), or log on to <www.coralstudy.com>. |
|
||||||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion