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

Purpose

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

Condition	Intervention	Phase
HIV Infections Cancer Pain	Drug: Ziconotide	Phase 2

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study Masking: Double-Blind 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 NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: Cancer Chronic Pain HIV/AIDS

Drug Information available for: Ziconotide

U.S. FDA Resources

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment:

100

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002160

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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
Univ of Tennessee
Memphis, Tennessee, United States, 38163
Methodist Hosp
Memphis, Tennessee, United States, 38104
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

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00002160 History of Changes
Other Study ID Numbers:	256A
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Pain

Palliative Care
omega-conopeptide MVIIA
Calcium Channel Blockers

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Calcium Channel Blockers
Ziconotide

Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Central Nervous System Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on May 22, 2013