Completed

Intrathecal SNX-111 for Chronic Pain in Cancer and AIDS Patients

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What is being tested

Ziconotide

Drug
Who is being recruted

Blood-Borne Infections+19

+ Urogenital Diseases

+ Genital Diseases

Over 18 Years
+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
See protocol details

Summary

Principal SponsorNeurex
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

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.

Principal SponsorNeurex
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

100 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsNeurologic ManifestationsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSigns and SymptomsSlow Virus DiseasesPathological Conditions, Signs and SymptomsVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsAcquired Immunodeficiency SyndromeAIDS-Related ComplexNeoplasmsPainHIV Infections

Criteria

4 inclusion criteria required to participate
Allowed concurrent medication: Rescue analgesia

Patients must have a life expectancy > 3 months (or 1 month if an infusion pump is in place)

Patients must have an unsatisfactory response to prior opioid therapy

Patients must have chronic pain related to AIDS or cancer

2 exclusion criteria prevent from participating
Patients with a history of heart disease, heart failure, or asthma are excluded

Patients with signs of sepsis or inadequately treated infection are excluded

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 44 locations

Ctr for Pain Management and Rehabilitation

Huntsville, United StatesOpen Ctr for Pain Management and Rehabilitation in Google Maps

Gulf Coast Clinical Services

Mobile, United States

Northport Hosp

Northport, United States

Holt Krock Clinic

Fort Smith, United States
Completed44 Study Centers