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

NCT00002160 | Completed Phase 2

• 1 other identifier: 256A
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 44

Brief Summary

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

Conditions

HIV Infections; Cancer; Pain

Keywords

Acquired Immunodeficiency Syndrome; AIDS-Related Complex; Pain; Palliative Care; omega-conopeptide MVIIA; Calcium Channel Blockers

Interventions

Ziconotide DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Neurex: lead

Study Sites (44)

Ctr for Pain Management and Rehabilitation

Huntsville, Alabama, 35801, United States

Location

Gulf Coast Clinical Services

Mobile, Alabama, 36603, United States

Location

Northport Hosp

Northport, Alabama, 35476, United States

Location

Holt Krock Clinic

Fort Smith, Arkansas, 72901, United States

Location

Alta Bates Hosp

Berkeley, California, 94704, United States

Location

Pain Diagnosis and Treatment

Glendora, California, 917414240, United States

Location

Univ of CA - San Diego

San Diego, California, 921038770, United States

Location

Good Samaritan Hosp Ctr

San Jose, California, 95124, United States

Location

Connecticut Pain Care

Danbury, Connecticut, 06810, United States

Location

VA Med Ctr / Oncology Section

Washington D.C., District of Columbia, 20422, United States

Location

Univ of Miami School of Medicine

Miami, Florida, 33136, United States

Location

H Lee Moffit Cancer Ctr and Research Institute

Tampa, Florida, 33612, United States

Location

Emory Univ Hosp

Atlanta, Georgia, 30322, United States

Location

Cook County Hosp

Chicago, Illinois, 60612, United States

Location

Pain Control Ctr

Chicago, Illinois, 60612, United States

Location

Elkhardt Gen Hosp

Elkhardt, Indiana, 46514, United States

Location

Neurosurgical Associates

Terre Haute, Indiana, 47804, United States

Location

Univ of Iowa Hosp

Iowa City, Iowa, 522421061, United States

Location

Univ of Kansas Med Ctr

Kansas City, Kansas, 661607415, United States

Location

New Orleans Pharmaceutical Research

Kenner, Louisiana, 70062, United States

Location

Louisiana State Univ

Shreveport, Louisiana, 711303932, United States

Location

Johns Hopkins Hosp

Baltimore, Maryland, 21205, United States

Location

Brigham and Women's Hosp

Boston, Massachusetts, 02115, United States

Location

Minneapolis Veterans Administration

Minneapolis, Minnesota, 55417, United States

Location

Univ of Missouri Med Ctr

Columbia, Missouri, 65212, United States

Location

The Pain Institute

Kansas City, Missouri, 64132, United States

Location

Cooper Hospital Early Intervention Program

Camden, New Jersey, 08103, United States

Location

Clinical Solutions

Princeton, New Jersey, 08540, United States

Location

Pain Management

New York, New York, 10021, United States

Location

Long Island Pain Management

Port Jefferson Station, New York, 11776, United States

Location

Univ of Rochester

Rochester, New York, 14642, United States

Location

Bowman Gray School of Medicine / Wake Forest Univ

Winston-Salem, North Carolina, 27157, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Lehigh Valley Hosp

Allentown, Pennsylvania, 18104, United States

Location

Pennsylvania State College of Medicine

Hershey, Pennsylvania, 17033, United States

Location

Thomas Jefferson Univ Hosp

Philadelphia, Pennsylvania, 19107, United States

Location

Methodist Hosp

Memphis, Tennessee, 38104, United States

Location

Univ of Tennessee

Memphis, Tennessee, 38163, United States

Location

Texas Tech Univ Health Science Ctr

Lubbock, Texas, 79430, United States

Location

Univ of Texas Health Sciences Ctr

San Antonio, Texas, 782847838, United States

Location

Fairfax Hosp

Falls Church, Virginia, 220423300, United States

Location

Swedish Pain Management

Seattle, Washington, 98104, United States

Location

Northwest Neuroscience Institute

Seattle, Washington, 98133, United States

Location

Marschfield Clinic

Marshfield, Wisconsin, 544495777, United States

Location

MeSH Terms

Conditions

HIV Infections; Neoplasms; Pain; Acquired Immunodeficiency Syndrome; AIDS-Related Complex

Interventions

ziconotide

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Slow Virus Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: DOUBLE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Last Updated: June 24, 2005

Record last verified: 1998-03

Locations

US (44)