Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2026-01-04 @ 8:37 AM
Study NCT ID:
NCT01087359
Status:
COMPLETED
Last Update Posted:
2011-06-20
First Post:
2010-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Antiinflammatoric and Antioxidative Effect of Melatonin in Human Endotoxaemia
Sponsor:
Herlev Hospital
Organization:
Study Overview
Official Title:
Antiinflammatoric and Antioxidative Effect of Melatonin in Human Endotoxaemia
Status:
COMPLETED
Status Verified Date:
2010-10
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:
This is a double blinded, randomised, crossover study with 12 healthy men between 18 and 40 year. The design is based on 6 days:
* day 1: On day time administration of LPS.
* day 2: On night time administration of LPS.
* day 3: On day time administration of LPS + Placebo.
* day 4: On day time administration of LPS + melatonin.
* day 5: On night time administration of LPS + placebo.
* day 6: On night time administration og LPS + melatonin.
Measuring the inflammatoric and oxidative response of LPS and the effect of melatonin compared to placebo on the endotoxaemia.
* day 1: On day time administration of LPS.
* day 2: On night time administration of LPS.
* day 3: On day time administration of LPS + Placebo.
* day 4: On day time administration of LPS + melatonin.
* day 5: On night time administration of LPS + placebo.
* day 6: On night time administration og LPS + melatonin.
Measuring the inflammatoric and oxidative response of LPS and the effect of melatonin compared to placebo on the endotoxaemia.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: