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A Multicenter, open-label study to evaluate the preliminary safety and efficacy of CC-5013 in the treatment of Complex Regional Pain Syndrome (CRPS) Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on A Multicenter, open-label study to evaluate the preliminary safety and efficacy of CC-5013 in the treatment of Complex Regional Pain Syndrome (CRPS) conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. A Multicenter, open-label study to evaluate the preliminary safety and efficacy of CC-5013 in the treatment of Complex Regional Pain Syndrome (CRPS) Clinical research trials and A Multicenter, open-label study to evaluate the preliminary safety and efficacy of CC-5013 in the treatment of Complex Regional Pain Syndrome (CRPS) medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like A Multicenter, open-label study to evaluate the preliminary safety and efficacy of CC-5013 in the treatment of Complex Regional Pain Syndrome (CRPS). A Multicenter, open-label study to evaluate the preliminary safety and efficacy of CC-5013 in the treatment of Complex Regional Pain Syndrome (CRPS) Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a A Multicenter, open-label study to evaluate the preliminary safety and efficacy of CC-5013 in the treatment of Complex Regional Pain Syndrome (CRPS) clinical trial. Subjects typically recieve the finest healthcare available for their A Multicenter, open-label study to evaluate the preliminary safety and efficacy of CC-5013 in the treatment of Complex Regional Pain Syndrome (CRPS) condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Multicenter, open-label study to evaluate the preliminary safety and efficacy of CC-5013 in the treatment of Complex Regional Pain Syndrome (CRPS)  A Multicenter, open-label study to evaluate the preliminary safety and efficacy of CC-5013 in the treatment of Complex Regional Pain Syndrome (CRPS)
A Multicenter, open-label study to evaluate the preliminary safety and efficacy of CC-5013 in the treatment of Complex Regional Pain Syndrome (CRPS)
For Condition: Complex Regional Pain Syndrome (RSD)
Status: No longer recruiting
Sponsor(s): Celgene Corporation ,
Synopsis: This is a multicenter, open-label study in adult subjects with Type 1 Complex Regional Pain Syndrome. Subjects diagnosed with unilateral Type 1 CRPS will be enrolled sequentially to receive CC-5013 10 mg/day orally. For each subject the study consists of two phases: Pre-treatment phase(1 wk) and treatment phase (12 wks)
Details:
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - A diagnosis of Type 1 CRPS as defined by modified International Association for the Study of Pain criteria (App 1) for at least one year duration - Unilateral involvement of a distal hand or foot with or without proximal speed must be present. The most severely affected limb will be designated the index limb. - CRPS pain severity score in the index limb of 4 or greater on an 11-point (0-10) NRS (Appendix I). - Opioid analgesics, non-opioid analgesics, non-steroidal anti-inflammatory drugs, anticonvulsants and antidepressant drugs may be continued provided that the subject was on stable doses for at least four weeks prior to the Treatment phase. - Understand and voluntarily sign an informed consent form - Able to adhere to the study visit schedule and other protocol requirements - Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test within 7 days of starting study drug. - In addition, sexually active WCBP must agree to use adequate contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) while on study drug. - WCBP must agree to have pregnancy tests every 4 weeks while on study drug. - The average CRPS pain severity score in the index limb at the end of the Pre-Treatment Phase I (must be 4 or greater) and 2 each of the daily scores over the week must be within +/- one point of this average. Exclusion Criteria: - Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form. - Prior treatment with CC-5013 - Prior development of an allergic reaction/hypersensitivity while taking thalidomide. - Prior development of a moderate or sever rash or any desquamation while taking thalidomide. - Pregnant or lactating females. - Active litigation, compensation or disability issues related to CRPS. - Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study. - Use of any other experimental drug or therapy within 28 days of the treatment phase.
Total Enrollment: 40
Location and Contact Information:
Johns Hopkins Hospital
Baltimore, Maryland, 21287
United States
Drexel University College of Medicine
Philadelphia, Pennsylvania, 19102
United States
UCSD Center for Pain and Palliative Medicine
La Jolla, California, 92093
United States
Swedish Pain Management
Seattle, Washington, 98122-4379
United States
The Center for Clinical Research
Winston Salem, North Carolina, 27103
United States
UNC Hospitals University of North Carolina
Chapel Hill, North Carolina, 27599-7010
United States
Additional Information:
Study ID Numbers: CC-5013-CRPS-001;
Study Start Date: August 2003
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00067743
Other Complex Regional Pain Syndrome (rsd) Studies:
1. A Multicenter, open-label study to evaluate the preliminary safety and efficacy of CC-5013 in the treatment of Complex Regional Pain Syndrome (CRPS)
Related Studies:
Other Complex Regional Pain Syndrome (RSD) Clinical Trials
Other North Carolina Clinical Trials
Other Winston Salem Clinical Trials
A Multicenter, open-label study to evaluate the preliminary safety and efficacy of CC-5013 in the treatment of Complex Regional Pain Syndrome (CRPS)
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