Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00101621
Status:
TERMINATED
Last Update Posted:
2006-02-09
First Post:
2005-01-12
Brief Title:
Pilot Study to Evaluate the Safety and Analgesic Activity of M40403 Co-Administered With an Opioid Agent for Cancer Pain
Sponsor:
MetaPhore Pharmaceuticals
Organization:
MetaPhore Pharmaceuticals
Study Overview
Official Title:
A Randomized Double-Blind Placebo Controlled Multi-Center Pilot Study to Evaluate the Safety and Analgesic Activity of M40403 Co-Administered With an Opioid Agent in a Cancer Pain Model
Status:
TERMINATED
Status Verified Date:
2006-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
M40403 was found to be effective in reducing pain in animal models and in clinical studies of subjects who were experiencing pain after dental surgery The proposed study is designed to investigate the efficacy and safety of M40403 when co-administered with an opioid in subjects with pain due to cancer
Detailed Description:
The proposed study is designed to investigate the efficacy safety and pharmacokinetics of M40403 in subjects with pain related to cancer Because the effects of M40403 have not been previously investigated in subjects with cancer-related pain the safety of single doses of 00625 0125 and 025 mgkg of M40403 will be evaluated in an open label phase of the study These doses of M40403 are similar to doses that were used in subjects who were experiencing pain in prior clinical studies with M40403
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None