Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2025-12-25 @ 8:24 PM
Study NCT ID:
NCT00446069
Status:
COMPLETED
Last Update Posted:
2016-08-29
First Post:
2007-03-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Efficacy and Safety Trial of Controlled Release (CR) Morphine in Cancer Patients
Sponsor:
Egalet Ltd
Organization:
Study Overview
Official Title:
A Double-blind, Randomized, 2-way Cross-over, Phase II, Efficacy Trial in Cancer Patients to Assess the Overall Efficacy, Patient Preference, Morphine Related Side Effect Profile and Safety of the Egalet® Controlled Release Morphine Formulation 30-240 mg Once Daily Compared to MST Continus® 15-120 mg Twice Daily After 2 Weeks of Treatment
Status:
COMPLETED
Status Verified Date:
2016-08
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:
The purpose of the study is to determine the effect of Egalet® Morphine once daily compared to MST Continus twice daily on pain intensity and use of rescue medication for break through pain after 2 weeks of treatment in patients with pain due to cancer.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| EudraCT number: 2006-006579-19 | None | None | View |