A Multicenter Phase II/III, Placebo-Controlled Study of SNX-111 Administered Intrathecally to Cancer and AIDS Patients With Chronic Pain
Patients are randomized to receive SNX-111 or placebo (AS PER AMENDMENT 1/22/98: with
randomization weighted 2:1 in favor of SNX-111) via external pump and an intrathecal
catheter (thin tube inserted into the spinal canal). (AS PER AMENDMENT 1/22/98: the dose is
increased every 24 hours, in the absence of onset of analgesia or adverse events. After 2-5
days, patients who respond to their medication continue treatment at home for 5-8 days.
Patients who do not respond will be switched to the other regimen (i.e., placebo to SNX-111,
or SNX-111 to placebo). After 10 days, responding patients are unblinded and asked to enroll
in the long-term, open-label extension protocol. Patients remain on a fixed dose at the
therapeutic level found in the previous study. The dose may be increased or decreased at the
discretion of the investigator. Patients may continue therapy on a long-term basis until
the drug is approved.
Interventional
Endpoint Classification: Safety Study, Masking: Double-Blind, Primary Purpose: Treatment
United States: Food and Drug Administration
256A
NCT00002160
Name | Location |
---|---|
Univ of Miami School of Medicine | Miami, Florida 331361013 |
Bowman Gray School of Medicine / Wake Forest Univ | Winston-Salem, North Carolina 27103 |
Johns Hopkins Hosp | Baltimore, Maryland 21287 |
Cook County Hosp | Chicago, Illinois 60612 |
Thomas Jefferson Univ Hosp | Philadelphia, Pennsylvania 191075098 |
Brigham and Women's Hosp | Boston, Massachusetts 02215 |
Ctr for Pain Management and Rehabilitation | Huntsville, Alabama 35801 |
Gulf Coast Clinical Services | Mobile, Alabama 36603 |
Northport Hosp | Northport, Alabama 35476 |
Holt Krock Clinic | Fort Smith, Arkansas 72901 |
Alta Bates Hosp | Berkeley, California 94704 |
Pain Diagnosis and Treatment | Glendora, California 917414240 |
Univ of CA - San Diego | San Diego, California 921038770 |
Good Samaritan Hosp Ctr | San Jose, California 95124 |
Connecticut Pain Care | Danbury, Connecticut 06810 |
VA Med Ctr / Oncology Section | Washington, District of Columbia 20422 |
H Lee Moffit Cancer Ctr and Research Institute | Tampa, Florida 33612 |
Emory Univ Hosp | Atlanta, Georgia 30322 |
Pain Control Ctr | Chicago, Illinois 60612 |
Elkhardt Gen Hosp | Elkhardt, Indiana 46514 |
Neurosurgical Associates | Terre Haute, Indiana 47804 |
Univ of Iowa Hosp | Iowa City, Iowa 522421061 |
Univ of Kansas Med Ctr | Kansas City, Kansas 661607415 |
New Orleans Pharmaceutical Research | Kenner, Louisiana 70062 |
Louisiana State Univ | Shreveport, Louisiana 711303932 |
Minneapolis Veterans Administration | Minneapolis, Minnesota 55417 |
Univ of Missouri Med Ctr | Columbia, Missouri 65212 |
The Pain Institute | Kansas City, Missouri 64132 |
Cooper Hospital Early Intervention Program | Camden, New Jersey 08103 |
Clinical Solutions | Princeton, New Jersey 08540 |
Pain Management | New York, New York 10021 |
Long Island Pain Management | Port Jefferson Station, New York 11776 |
Univ of Rochester | Rochester, New York 14642 |
Cleveland Clinic Foundation | Cleveland, Ohio 44195 |
Lehigh Valley Hosp | Allentown, Pennsylvania 18104 |
Pennsylvania State College of Medicine | Hershey, Pennsylvania 17033 |
Univ of Tennessee | Memphis, Tennessee 38163 |
Methodist Hosp | Memphis, Tennessee 38104 |
Texas Tech Univ Health Science Ctr | Lubbock, Texas 79430 |
Univ of Texas Health Sciences Ctr | San Antonio, Texas 782847838 |
Fairfax Hosp | Falls Church, Virginia 220423300 |
Swedish Pain Management | Seattle, Washington 98104 |
Northwest Neuroscience Institute | Seattle, Washington 98133 |
Marschfield Clinic | Marshfield, Wisconsin 544495777 |