Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00002160
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
A Multicenter Phase IIIII Placebo-Controlled Study of SNX-111 Administered Intrathecally to Cancer and AIDS Patients With Chronic Pain
Sponsor:
Neurex
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Multicenter Phase IIIII Placebo-Controlled Study of SNX-111 Administered Intrathecally to Cancer and AIDS Patients With Chronic Pain
Status:
COMPLETED
Status Verified Date:
1998-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 12298 with randomization weighted 21 in favor of SNX-111 via external pump and an intrathecal catheter thin tube inserted into the spinal canal AS PER AMENDMENT 12298 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 ie 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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: