Ignite Creation Date:
2025-12-24 @ 4:58 PM
Ignite Modification Date:
2025-12-28 @ 2:57 AM
Study NCT ID:
NCT05070650
Status:
WITHDRAWN
Last Update Posted:
2024-09-26
First Post:
2021-09-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of the Combination of Acetylcysteine, Paracetamol and Phenylephrine for the Treatment of Common Cold
Sponsor:
Sandoz
Organization:
Study Overview
Official Title:
Efficacy and Safety of the Combination of Acetylcysteine, Paracetamol and Phenylephrine for the Treatment of Common Cold: a Prospective, Randomized, Double-blind, Controlled Trial
Status:
WITHDRAWN
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sandoz has decided to withdraw the clinical study due to internal business reasons. No patients were enrolled in any of the participating countries.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Prospective, randomized, multinational, multicenter, double-blind trial in 2 parallel groups of patients
Detailed Description:
This study is a prospective, randomized, multinational, multicenter, double-blind trial in 2 parallel groups of patients.
Patients will undergo screening examinations at Visit 1.
Patients who meet all of the inclusion and none of the exclusion criteria will be randomized to double-blind treatment with one of the following:
* Group A: Acetylcysteine/Paracetamol/Phenylephrine: one sachet three times per day OR
* Group B: Paracetamol/Phenylephrine 500 mg/10 mg granules for oral solution: one sachet three times per day.
A control visit (Visit 2) is planned on Day 3 of treatment.
After the end of the double-blind treatment phase, the patients will undergo an end-of-treatment (EOT) examination at Visit 3 on Day 6.
Patients will undergo screening examinations at Visit 1.
Patients who meet all of the inclusion and none of the exclusion criteria will be randomized to double-blind treatment with one of the following:
* Group A: Acetylcysteine/Paracetamol/Phenylephrine: one sachet three times per day OR
* Group B: Paracetamol/Phenylephrine 500 mg/10 mg granules for oral solution: one sachet three times per day.
A control visit (Visit 2) is planned on Day 3 of treatment.
After the end of the double-blind treatment phase, the patients will undergo an end-of-treatment (EOT) examination at Visit 3 on Day 6.
Study Oversight
Has Oversight DMC:
None
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?: