Advertisement

Topics

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

2014-08-27 03:59:14 | BioPortfolio

Summary

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

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.

Study Design

Endpoint Classification: Safety Study, Masking: Double-Blind, Primary Purpose: Treatment

Conditions

HIV Infections

Intervention

Ziconotide

Location

Ctr for Pain Management and Rehabilitation
Huntsville
Alabama
United States
35801

Status

Completed

Source

NIH AIDS Clinical Trials Information Service

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:59:14-0400

Clinical Trials [205 Associated Clinical Trials listed on BioPortfolio]

Ziconotide Effectiveness and Safety Trial in Patients With Chronic Severe Pain

The purpose of this open-label study is to give chronic severe pain patients with existing intrathecal pump systems access to ziconotide.

Prialt (Ziconotide) In Severe Chronic Pain

The purpose of this study is to understand the effects of intrathecal ziconotide (an experimental pain medication) when the dose is slowly increased over a 3-week period in patients with s...

Ziconotide as First-Line IDT

The primary objective of this study is to prospectively examine outcomes in 12 patients using ziconotide Intrathecal Drug Therapy(IDT) as first-line monotherapy with the use of an algorith...

Japanese Study Evaluating Safety, Efficacy and Acceptability of Telithromycin in Children With Infections

The primary objective is to assess the safety of telithromycin (HMR 3647) (20% fine granules) 1g filling sachet in children with infections (Respiratory tract infections, Dermatological in...

An Investigational Agent for the Treatment of Complicated Intra-Abdominal Infections or Acute Pelvic Infections

The purpose of this study is to determine the effect of an approved medication for adults for an investigational use in pediatric patients 3 months to 17 years for the treatment of complic...

PubMed Articles [3392 Associated PubMed Articles listed on BioPortfolio]

Pain therapeutics from cone snail venoms: From Ziconotide to novel non-opioid pathways.

There have been numerous attempts to develop non-opioid drugs for severe pain, but the vast majority of these efforts have failed. A notable exception is Ziconotide (Prialt®), approved by the FDA in ...

A New Scoring System to Predict Blood Stream Infections in Patients with Complicated Intra-Abdominal Infections: Experience from a Tertiary Referral Hospital in China.

This purpose of this study was to investigate the effects of blood stream infections (BSIs) on the prognosis of patients with complicated intra-abdominal infections (IAIs) and to make predictions base...

mircoRNA-3162-3p is a potential biomarker to identify new infections in HIV-1-infected patients.

Identification of new HIV infections (HIV incidence) is critical for monitoring AIDS epidemic and assessing the effectiveness of intervention measures. However, current methods for distinguishing new ...

Childhood Infections and Subsequent School Achievement Among 598,553 Danish Children.

Hospitalizations for infections have been associated with subsequent decreased cognitive ability, but it is uncertain if childhood infections influence subsequent scholastic achievement (SA). We aimed...

Systematic reviews of point-of-care tests for the diagnosis of urogenital Chlamydia trachomatis infections.

WHO estimates that 131 million new cases of urogenital Chlamydia trachomatis (CT) infections occur globally every year. Most infections are asymptomatic. Untreated infection in women can lead to sev...

Medical and Biotech [MESH] Definitions

Inflammation of brain parenchymal tissue as a result of viral infection. Encephalitis may occur as primary or secondary manifestation of TOGAVIRIDAE INFECTIONS; HERPESVIRIDAE INFECTIONS; ADENOVIRIDAE INFECTIONS; FLAVIVIRIDAE INFECTIONS; BUNYAVIRIDAE INFECTIONS; PICORNAVIRIDAE INFECTIONS; PARAMYXOVIRIDAE INFECTIONS; ORTHOMYXOVIRIDAE INFECTIONS; RETROVIRIDAE INFECTIONS; and ARENAVIRIDAE INFECTIONS.

Viral infections of the leptomeninges and subarachnoid space. TOGAVIRIDAE INFECTIONS; FLAVIVIRIDAE INFECTIONS; RUBELLA; BUNYAVIRIDAE INFECTIONS; ORBIVIRUS infections; PICORNAVIRIDAE INFECTIONS; ORTHOMYXOVIRIDAE INFECTIONS; RHABDOVIRIDAE INFECTIONS; ARENAVIRIDAE INFECTIONS; HERPESVIRIDAE INFECTIONS; ADENOVIRIDAE INFECTIONS; JC VIRUS infections; and RETROVIRIDAE INFECTIONS may cause this form of meningitis. Clinical manifestations include fever, headache, neck pain, vomiting, PHOTOPHOBIA, and signs of meningeal irritation. (From Joynt, Clinical Neurology, 1996, Ch26, pp1-3)

Infections with viruses of the family PARAMYXOVIRIDAE. This includes MORBILLIVIRUS INFECTIONS; RESPIROVIRUS INFECTIONS; PNEUMOVIRUS INFECTIONS; HENIPAVIRUS INFECTIONS; AVULAVIRUS INFECTIONS; and RUBULAVIRUS INFECTIONS.

Pathogenic infections of the brain, spinal cord, and meninges. DNA VIRUS INFECTIONS; RNA VIRUS INFECTIONS; BACTERIAL INFECTIONS; MYCOPLASMA INFECTIONS; SPIROCHAETALES INFECTIONS; fungal infections; PROTOZOAN INFECTIONS; HELMINTHIASIS; and PRION DISEASES may involve the central nervous system as a primary or secondary process.

Infections with viruses of the order MONONEGAVIRALES. The concept includes FILOVIRIDAE INFECTIONS; PARAMYXOVIRIDAE INFECTIONS; and RHABDOVIRIDAE INFECTIONS.

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

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Pain
Pain is defined by the International Association for the Study of Pain as “an unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage”. Some illnesses can be excruci...

Head and neck cancers
Cancer can occur in any of the tissues or organs in the head and neck. There are over 30 different places that cancer can develop in the head and neck area. Mouth cancers (oral cancers)  - Mouth cancer can develop on the lip, the tongue, the floor...

Pharmacy
Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...


Searches Linking to this Trial