Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00331045
Status:
TERMINATED
Last Update Posted:
2015-09-02
First Post:
2006-05-26
Brief Title:
Clinical Evaluation Of Alvimopan SB767905 On Constipation And Related Symptoms Associated With Opioid
Sponsor:
Cubist Pharmaceuticals LLC a subsidiary of Merck Co Inc Rahway New Jersey USA
Organization:
Cubist Pharmaceuticals LLC a subsidiary of Merck Co Inc Rahway New Jersey USA
Study Overview
Official Title:
Clinical Evaluation of Alvimopan SB767905 on Constipation and Related Symptoms Associated With Opioid -A Placebo-controlled Double-blind Study in Cancer Patients-
Status:
TERMINATED
Status Verified Date:
2009-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Subject registration did not proceed as expected difficult to complete within scheduled time frame prematurely terminated w 21 subjects randomized
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is intended to investigate the recommended dose of alvimopan in doses 025mgday 025mg OD 05mgday 025mg BID or 1mgday 05mg BID or placebo for 3 weeks in patients who receive opioids for the management of cancer pain and develop constipation by giving overall consideration to the efficacy and safety data in each treatment group Also efficacy and safety data of alvimopan in the recommended dose group will be compared with those of placebo and to confirm alvimopans safety and efficacy
Detailed Description:
None
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