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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

Primary Purpose

HIV Infections, Cancer, Pain

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ziconotide
Sponsored by
Neurex
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Pain, Palliative Care, omega-conopeptide MVIIA, Calcium Channel Blockers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ctr for Pain Management and Rehabilitation
  • Gulf Coast Clinical Services
  • Northport Hosp
  • Holt Krock Clinic
  • Alta Bates Hosp
  • Pain Diagnosis and Treatment
  • Univ of CA - San Diego
  • Good Samaritan Hosp Ctr
  • Connecticut Pain Care
  • VA Med Ctr / Oncology Section
  • Univ of Miami School of Medicine
  • H Lee Moffit Cancer Ctr and Research Institute
  • Emory Univ Hosp
  • Cook County Hosp
  • Pain Control Ctr
  • Elkhardt Gen Hosp
  • Neurosurgical Associates
  • Univ of Iowa Hosp
  • Univ of Kansas Med Ctr
  • New Orleans Pharmaceutical Research
  • Louisiana State Univ
  • Johns Hopkins Hosp
  • Brigham and Women's Hosp
  • Minneapolis Veterans Administration
  • Univ of Missouri Med Ctr
  • The Pain Institute
  • Cooper Hospital Early Intervention Program
  • Clinical Solutions
  • Pain Management
  • Long Island Pain Management
  • Univ of Rochester
  • Bowman Gray School of Medicine / Wake Forest Univ
  • Cleveland Clinic Foundation
  • Lehigh Valley Hosp
  • Pennsylvania State College of Medicine
  • Thomas Jefferson Univ Hosp
  • Methodist Hosp
  • Univ of Tennessee
  • Texas Tech Univ Health Science Ctr
  • Univ of Texas Health Sciences Ctr
  • Fairfax Hosp
  • Swedish Pain Management
  • Northwest Neuroscience Institute
  • Marschfield Clinic

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Neurex
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1. Study Identification

Unique Protocol Identification Number
NCT00002160
Brief Title
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

2. Study Status

Record Verification Date
March 1998
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Neurex

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Cancer, Pain
Keywords
Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Pain, Palliative Care, omega-conopeptide MVIIA, Calcium Channel Blockers

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
Double
Enrollment
100 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Ziconotide

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Ctr for Pain Management and Rehabilitation
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Gulf Coast Clinical Services
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36603
Country
United States
Facility Name
Northport Hosp
City
Northport
State/Province
Alabama
ZIP/Postal Code
35476
Country
United States
Facility Name
Holt Krock Clinic
City
Fort Smith
State/Province
Arkansas
ZIP/Postal Code
72901
Country
United States
Facility Name
Alta Bates Hosp
City
Berkeley
State/Province
California
ZIP/Postal Code
94704
Country
United States
Facility Name
Pain Diagnosis and Treatment
City
Glendora
State/Province
California
ZIP/Postal Code
917414240
Country
United States
Facility Name
Univ of CA - San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
921038770
Country
United States
Facility Name
Good Samaritan Hosp Ctr
City
San Jose
State/Province
California
ZIP/Postal Code
95124
Country
United States
Facility Name
Connecticut Pain Care
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Facility Name
VA Med Ctr / Oncology Section
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20422
Country
United States
Facility Name
Univ of Miami School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
H Lee Moffit Cancer Ctr and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Emory Univ Hosp
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Cook County Hosp
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Pain Control Ctr
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Elkhardt Gen Hosp
City
Elkhardt
State/Province
Indiana
ZIP/Postal Code
46514
Country
United States
Facility Name
Neurosurgical Associates
City
Terre Haute
State/Province
Indiana
ZIP/Postal Code
47804
Country
United States
Facility Name
Univ of Iowa Hosp
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
522421061
Country
United States
Facility Name
Univ of Kansas Med Ctr
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
661607415
Country
United States
Facility Name
New Orleans Pharmaceutical Research
City
Kenner
State/Province
Louisiana
ZIP/Postal Code
70062
Country
United States
Facility Name
Louisiana State Univ
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
711303932
Country
United States
Facility Name
Johns Hopkins Hosp
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
Brigham and Women's Hosp
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Minneapolis Veterans Administration
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
Country
United States
Facility Name
Univ of Missouri Med Ctr
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Facility Name
The Pain Institute
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
Country
United States
Facility Name
Cooper Hospital Early Intervention Program
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
Clinical Solutions
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
08540
Country
United States
Facility Name
Pain Management
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Long Island Pain Management
City
Port Jefferson Station
State/Province
New York
ZIP/Postal Code
11776
Country
United States
Facility Name
Univ of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Bowman Gray School of Medicine / Wake Forest Univ
City
Winston Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Lehigh Valley Hosp
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18104
Country
United States
Facility Name
Pennsylvania State College of Medicine
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Thomas Jefferson Univ Hosp
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Methodist Hosp
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
Univ of Tennessee
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38163
Country
United States
Facility Name
Texas Tech Univ Health Science Ctr
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79430
Country
United States
Facility Name
Univ of Texas Health Sciences Ctr
City
San Antonio
State/Province
Texas
ZIP/Postal Code
782847838
Country
United States
Facility Name
Fairfax Hosp
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
220423300
Country
United States
Facility Name
Swedish Pain Management
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Northwest Neuroscience Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98133
Country
United States
Facility Name
Marschfield Clinic
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
544495777
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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