Ignite Creation Date:
2025-12-24 @ 4:39 PM
Ignite Modification Date:
2026-01-30 @ 10:57 PM
Study NCT ID:
NCT02972866
Status:
WITHDRAWN
Last Update Posted:
2019-10-09
First Post:
2016-11-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study, Non Inferiority Between Noex® 32µg Versus Budecort Aqua® 32µg in Treatment of Alergic Rhinitis
Sponsor:
Eurofarma Laboratorios S.A.
Organization:
Study Overview
Official Title:
Phase III, Multicenter, Randomized, Simple-blinded, Paralel Groups to Evaluate Non Inferiority of Noex® 32µg Versus Budecort Aqua® 32µg in Treatment of Alergic Persistent Rhinitis Moderate to Severe
Status:
WITHDRAWN
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Regulatory strategy
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RINEX32
Brief Summary:
This study is to evaluate non inferiority of Eurofarma budesonide nasal spary x referral Astrazeneca budesonide. Half patients will receive Eurofarma medication and half patients will receive Astrazeneca medication. There is no placebo group.
Detailed Description:
Budesonide is a medicine already very used and registered about 20 years. Eurofarma has the intention to collect more data about safety and efficacy and present them to local authority.
This study was draw to treat patients with persisntent rhinits moderate to severe in sites localted locally in Brasil.
This study was draw to treat patients with persisntent rhinits moderate to severe in sites localted locally in Brasil.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: