Ignite Creation Date:
2024-05-05 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00412152
Status:
COMPLETED
Last Update Posted:
2018-10-23
First Post:
2006-12-14
Brief Title:
Oxycodone-naloxone in Relieving Opioid-related Constipation
Sponsor:
Mundipharma Research GmbH Co KG
Organization:
Mundipharma Research GmbH Co KG
Study Overview
Official Title:
A Randomised Double-blind Parallel-group Multicentre Study to Demonstrate Improvement in Symptoms of Constipation in Subjects With Non-malignant Pain Taking Oxycodone Equivalent of 20 mgDay and 50 mgDay as OxycodoneNaloxone Prolonged Release Compared to Subjects Taking Oxycodone Prolonged Release Tablets Alone
Status:
COMPLETED
Status Verified Date:
2018-10
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 primary objective of this study is to demonstrate that subjects with moderate to severe non-malignant pain taking oxycodonenaloxone prolonged release tablets have improvement in symptoms of constipation compared to subjects taking oxycodone prolonged release tablets alone
Detailed Description:
Patients with a documented history of moderate to severe non-malignant pain that require around the clock opioid therapy will be randomised to an oxycodone or an oxycodone-naloxone treatment arm to assess the safety and efficacy of oxycodonenaloxone prolonged release compared to oxycodone prolonged-release in relieving opioid-related constipation
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2005-002398-57 | EUDRACT_NUMBER | None | None |