Clinical trial NCT00002160: A Multicenter Phase II/III, Placebo-Controlled Study of SNX-111 Administered Intrathecally to Cancer and AIDS Patients With Chronic Pain
Official title: A Multicenter Phase II/III, Placebo-Controlled Study of SNX-111 Administered Intrathecally to Cancer and AIDS Patients With Chronic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infections
Cancer
Pain
Keywords: Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Pain
Palliative Care
omega-conopeptide MVIIA
Calcium Channel Blockers
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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

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 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Ctr for Pain Management and Rehabilitation
state: Alabama
city: Mobile
country: United States
facility: Gulf Coast Clinical Services
state: Alabama
city: Northport
country: United States
facility: Northport Hosp
state: Alabama
city: Fort Smith
country: United States
facility: Holt Krock Clinic
state: Arkansas
city: Berkeley
country: United States
facility: Alta Bates Hosp
state: California
city: Glendora
country: United States
facility: Pain Diagnosis and Treatment
state: California
city: San Diego
country: United States
facility: Univ of CA - San Diego
state: California
city: San Jose
country: United States
facility: Good Samaritan Hosp Ctr
state: California
city: Danbury
country: United States
facility: Connecticut Pain Care
state: Connecticut
city: Washington
country: United States
facility: VA Med Ctr / Oncology Section
state: District of Columbia
city: Miami
country: United States
facility: Univ of Miami School of Medicine
state: Florida
city: Tampa
country: United States
facility: H Lee Moffit Cancer Ctr and Research Institute
state: Florida
city: Atlanta
country: United States
facility: Emory Univ Hosp
state: Georgia
city: Chicago
country: United States
facility: Cook County Hosp
state: Illinois
city: Chicago
country: United States
facility: Pain Control Ctr
state: Illinois
city: Elkhardt
country: United States
facility: Elkhardt Gen Hosp
state: Indiana
city: Terre Haute
country: United States
facility: Neurosurgical Associates
state: Indiana
city: Iowa City
country: United States
facility: Univ of Iowa Hosp
state: Iowa
city: Kansas City
country: United States
facility: Univ of Kansas Med Ctr
state: Kansas
city: Kenner
country: United States
facility: New Orleans Pharmaceutical Research
state: Louisiana
city: Shreveport
country: United States
facility: Louisiana State Univ
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins Hosp
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hosp
state: Massachusetts
city: Minneapolis
country: United States
facility: Minneapolis Veterans Administration
state: Minnesota
city: Columbia
country: United States
facility: Univ of Missouri Med Ctr
state: Missouri
city: Kansas City
country: United States
facility: The Pain Institute
state: Missouri
city: Camden
country: United States
facility: Cooper Hospital Early Intervention Program
state: New Jersey
city: Princeton
country: United States
facility: Clinical Solutions
state: New Jersey
city: New York
country: United States
facility: Pain Management
state: New York
city: Port Jefferson Station
country: United States
facility: Long Island Pain Management
state: New York
city: Rochester
country: United States
facility: Univ of Rochester
state: New York
city: Winston Salem
country: United States
facility: Bowman Gray School of Medicine / Wake Forest Univ
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Allentown
country: United States
facility: Lehigh Valley Hosp
state: Pennsylvania
city: Hershey
country: United States
facility: Pennsylvania State College of Medicine
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson Univ Hosp
state: Pennsylvania
city: Memphis
country: United States
facility: Methodist Hosp
state: Tennessee
city: Memphis
country: United States
facility: Univ of Tennessee
state: Tennessee
city: Lubbock
country: United States
facility: Texas Tech Univ Health Science Ctr
state: Texas
city: San Antonio
country: United States
facility: Univ of Texas Health Sciences Ctr
state: Texas
city: Falls Church
country: United States
facility: Fairfax Hosp
state: Virginia
city: Seattle
country: United States
facility: Swedish Pain Management
state: Washington
city: Seattle
country: United States
facility: Northwest Neuroscience Institute
state: Washington
city: Marshfield
country: United States
facility: Marschfield Clinic
state: Wisconsin
Study officials:
References: