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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
N/A
Not Enrolling
Both
HIV Infections, Cancer, Pain

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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:

Allowed:

- 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:

Interventional

Study Design:

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

Authority:

United States: Food and Drug Administration

Study ID:

256A

NCT ID:

NCT00002160

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

Name

Location

Univ of Miami School of MedicineMiami, Florida  331361013
Bowman Gray School of Medicine / Wake Forest UnivWinston-Salem, North Carolina  27103
Johns Hopkins HospBaltimore, Maryland  21287
Cook County HospChicago, Illinois  60612
Thomas Jefferson Univ HospPhiladelphia, Pennsylvania  191075098
Brigham and Women's HospBoston, Massachusetts  02215
Ctr for Pain Management and RehabilitationHuntsville, Alabama  35801
Gulf Coast Clinical ServicesMobile, Alabama  36603
Northport HospNorthport, Alabama  35476
Holt Krock ClinicFort Smith, Arkansas  72901
Alta Bates HospBerkeley, California  94704
Pain Diagnosis and TreatmentGlendora, California  917414240
Univ of CA - San DiegoSan Diego, California  921038770
Good Samaritan Hosp CtrSan Jose, California  95124
Connecticut Pain CareDanbury, Connecticut  06810
VA Med Ctr / Oncology SectionWashington, District of Columbia  20422
H Lee Moffit Cancer Ctr and Research InstituteTampa, Florida  33612
Emory Univ HospAtlanta, Georgia  30322
Pain Control CtrChicago, Illinois  60612
Elkhardt Gen HospElkhardt, Indiana  46514
Neurosurgical AssociatesTerre Haute, Indiana  47804
Univ of Iowa HospIowa City, Iowa  522421061
Univ of Kansas Med CtrKansas City, Kansas  661607415
New Orleans Pharmaceutical ResearchKenner, Louisiana  70062
Louisiana State UnivShreveport, Louisiana  711303932
Minneapolis Veterans AdministrationMinneapolis, Minnesota  55417
Univ of Missouri Med CtrColumbia, Missouri  65212
The Pain InstituteKansas City, Missouri  64132
Cooper Hospital Early Intervention ProgramCamden, New Jersey  08103
Clinical SolutionsPrinceton, New Jersey  08540
Pain ManagementNew York, New York  10021
Long Island Pain ManagementPort Jefferson Station, New York  11776
Univ of RochesterRochester, New York  14642
Cleveland Clinic FoundationCleveland, Ohio  44195
Lehigh Valley HospAllentown, Pennsylvania  18104
Pennsylvania State College of MedicineHershey, Pennsylvania  17033
Univ of TennesseeMemphis, Tennessee  38163
Methodist HospMemphis, Tennessee  38104
Texas Tech Univ Health Science CtrLubbock, Texas  79430
Univ of Texas Health Sciences CtrSan Antonio, Texas  782847838
Fairfax HospFalls Church, Virginia  220423300
Swedish Pain ManagementSeattle, Washington  98104
Northwest Neuroscience InstituteSeattle, Washington  98133
Marschfield ClinicMarshfield, Wisconsin  544495777