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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00002160
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Information provided by:
NIH AIDS Clinical Trials Information Service

Brief Summary:
To determine the safety and efficacy of SNX-111 in controlling severe, chronic pain in cancer and AIDS patients.

Condition or disease Intervention/treatment Phase
HIV Infections Cancer Pain Drug: Ziconotide Phase 2

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Masking: Double
Primary Purpose: Treatment
Official Title: A Multicenter Phase II/III, Placebo-Controlled Study of SNX-111 Administered Intrathecally to Cancer and AIDS Patients With Chronic Pain

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain
Drug Information available for: Ziconotide
U.S. FDA Resources

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00002160

  Hide Study Locations
United States, Alabama
Ctr for Pain Management and Rehabilitation
Huntsville, Alabama, United States, 35801
Gulf Coast Clinical Services
Mobile, Alabama, United States, 36603
Northport Hosp
Northport, Alabama, United States, 35476
United States, Arkansas
Holt Krock Clinic
Fort Smith, Arkansas, United States, 72901
United States, California
Alta Bates Hosp
Berkeley, California, United States, 94704
Pain Diagnosis and Treatment
Glendora, California, United States, 917414240
Univ of CA - San Diego
San Diego, California, United States, 921038770
Good Samaritan Hosp Ctr
San Jose, California, United States, 95124
United States, Connecticut
Connecticut Pain Care
Danbury, Connecticut, United States, 06810
United States, District of Columbia
VA Med Ctr / Oncology Section
Washington, District of Columbia, United States, 20422
United States, Florida
Univ of Miami School of Medicine
Miami, Florida, United States, 33136
H Lee Moffit Cancer Ctr and Research Institute
Tampa, Florida, United States, 33612
United States, Georgia
Emory Univ Hosp
Atlanta, Georgia, United States, 30322
United States, Illinois
Cook County Hosp
Chicago, Illinois, United States, 60612
Pain Control Ctr
Chicago, Illinois, United States, 60612
United States, Indiana
Elkhardt Gen Hosp
Elkhardt, Indiana, United States, 46514
Neurosurgical Associates
Terre Haute, Indiana, United States, 47804
United States, Iowa
Univ of Iowa Hosp
Iowa City, Iowa, United States, 522421061
United States, Kansas
Univ of Kansas Med Ctr
Kansas City, Kansas, United States, 661607415
United States, Louisiana
New Orleans Pharmaceutical Research
Kenner, Louisiana, United States, 70062
Louisiana State Univ
Shreveport, Louisiana, United States, 711303932
United States, Maryland
Johns Hopkins Hosp
Baltimore, Maryland, United States, 21205
United States, Massachusetts
Brigham and Women's Hosp
Boston, Massachusetts, United States, 02115
United States, Minnesota
Minneapolis Veterans Administration
Minneapolis, Minnesota, United States, 55417
United States, Missouri
Univ of Missouri Med Ctr
Columbia, Missouri, United States, 65212
The Pain Institute
Kansas City, Missouri, United States, 64132
United States, New Jersey
Cooper Hospital Early Intervention Program
Camden, New Jersey, United States, 08103
Clinical Solutions
Princeton, New Jersey, United States, 08540
United States, New York
Pain Management
New York, New York, United States, 10021
Long Island Pain Management
Port Jefferson Station, New York, United States, 11776
Univ of Rochester
Rochester, New York, United States, 14642
United States, North Carolina
Bowman Gray School of Medicine / Wake Forest Univ
Winston Salem, North Carolina, United States, 27157
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Lehigh Valley Hosp
Allentown, Pennsylvania, United States, 18104
Pennsylvania State College of Medicine
Hershey, Pennsylvania, United States, 17033
Thomas Jefferson Univ Hosp
Philadelphia, Pennsylvania, United States, 19107
United States, Tennessee
Methodist Hosp
Memphis, Tennessee, United States, 38104
Univ of Tennessee
Memphis, Tennessee, United States, 38163
United States, Texas
Texas Tech Univ Health Science Ctr
Lubbock, Texas, United States, 79430
Univ of Texas Health Sciences Ctr
San Antonio, Texas, United States, 782847838
United States, Virginia
Fairfax Hosp
Falls Church, Virginia, United States, 220423300
United States, Washington
Swedish Pain Management
Seattle, Washington, United States, 98104
Northwest Neuroscience Institute
Seattle, Washington, United States, 98133
United States, Wisconsin
Marschfield Clinic
Marshfield, Wisconsin, United States, 544495777
Sponsors and Collaborators
Neurex Identifier: NCT00002160     History of Changes
Other Study ID Numbers: 256A
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: March 1998

Keywords provided by NIH AIDS Clinical Trials Information Service:
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Palliative Care
omega-conopeptide MVIIA
Calcium Channel Blockers

Additional relevant MeSH terms:
HIV Infections
Chronic Pain
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents