Ignite Creation Date:
2025-12-18 @ 8:19 AM
Ignite Modification Date:
2025-12-23 @ 9:19 PM
Study NCT ID:
NCT00977223
Status:
None
Last Update Posted:
2012-02-16 00:00:00
First Post:
2009-09-14 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Substance P Antagonists on Adrenal Secretion
Sponsor:
None
Organization:
Study Overview
Official Title:
Pilot Study of the Action of the Substance P Antagonist Aprepitant on Aldosterone and Cortisol Secretion in Healthy Volunteers.
Status:
None
Status Verified Date:
2012-02
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:
APHOS
Brief Summary:
STUDY DESIGN
Phase IV, proof of concept, interventional, monocentric, randomised, double blind, cross-over study: The effects of a substance P antagonist (Emend) on corticosteroid secretion will be compared to those of a placebo.
STUDY OBJECTIVES
Main objective: to verify that adrenal corticosteroid secretion is actually controlled by substance P.
Secondary objective: to determine the physiological conditions that involve the control of adrenocortical function by tachykinins.
NUMBER OF SUBJECTS
20 healthy volunteers
ELIGIBILITY CRITERIA
(see below)
DURATION OF STUDY
Overall duration: 13 months Inclusion period: 12 months Follow up period (for 1 subject): 5 weeks Exclusion period: 1 month
ENDPOINTS
PRIMARY ENDPOINT: blood aldosterone variation during orthostatic test
SECONDARY ENDPOINTS
Basal aldosterone alteration Aldosterone variation during metoclopramide \& hypoglycaemia tests Basal and stimulated (3 different tests) alterations of renin, cortisol \& ACTH
REGULATORY AUTHORIZATIONS
Ethics committee authorization: dec 18th, 2008 Regulatory authorization: march 3rd, 2009
Phase IV, proof of concept, interventional, monocentric, randomised, double blind, cross-over study: The effects of a substance P antagonist (Emend) on corticosteroid secretion will be compared to those of a placebo.
STUDY OBJECTIVES
Main objective: to verify that adrenal corticosteroid secretion is actually controlled by substance P.
Secondary objective: to determine the physiological conditions that involve the control of adrenocortical function by tachykinins.
NUMBER OF SUBJECTS
20 healthy volunteers
ELIGIBILITY CRITERIA
(see below)
DURATION OF STUDY
Overall duration: 13 months Inclusion period: 12 months Follow up period (for 1 subject): 5 weeks Exclusion period: 1 month
ENDPOINTS
PRIMARY ENDPOINT: blood aldosterone variation during orthostatic test
SECONDARY ENDPOINTS
Basal aldosterone alteration Aldosterone variation during metoclopramide \& hypoglycaemia tests Basal and stimulated (3 different tests) alterations of renin, cortisol \& ACTH
REGULATORY AUTHORIZATIONS
Ethics committee authorization: dec 18th, 2008 Regulatory authorization: march 3rd, 2009
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?: