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A Multicenter Phase II/III, Placebo-Controlled Study of SNX-111 Administered Intrathecally to Cancer and AIDS Patients With Chronic Pain

Phase 2
18 Years
Not Enrolling
HIV Infections, Cancer, Pain

Thank you

Trial Information

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.

Inclusion Criteria

Inclusion Criteria

Concurrent Medication:


- Rescue analgesia.

Patients must have:

- Chronic pain related to AIDS or cancer.

- Unsatisfactory response to prior opioid therapy.

- Life expectancy > 3 months (or 1 month if an infusion pump is in place).

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

- Signs of sepsis or inadequately treated infection.

Patients with the following prior conditions are excluded:

History of heart disease, heart failure, or asthma.

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Masking: Double-Blind, Primary Purpose: Treatment


United States: Food and Drug Administration

Study ID:




Start Date:

Completion Date:

Related Keywords:

  • HIV Infections
  • Cancer
  • Pain
  • Acquired Immunodeficiency Syndrome
  • AIDS-Related Complex
  • Pain
  • Palliative Care
  • omega-conopeptide MVIIA
  • Calcium Channel Blockers
  • HIV Infections
  • Acquired Immunodeficiency Syndrome



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