Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06531707
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-18
Brief Title:
Efficacy and Safety in the Combination of Ibuprofen Loratadine Versus Ibuprofen Versus Loratadine
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy and Safety of IbuprofenLoratadine Fixed-dose Combination Versus the Fixed-dose Administration of Monotherapy as Symptomatic Treatment for Patients With the Common Cold
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Phase III longitudinal multicenter randomized double-blind clinical trial The aim of this study is to evaluate the efficacy and safety of the drug combination of IbuprofenLoratadine versus Ibuprofen versus Loratadine as monotherapy for the symptomatic treatment of the common cold
Detailed Description:
Researchers will compare the fixed-dose combination of Ibuprofen Loratadine versus Ibuprofen versus Loratadine for the symptomatic treatment of the common cold The adverse events related to the interventions will be registered during follow up
In the event that the symptoms worsen or the patients clinical condition warrants the use of any additional medication the principal investigator or designated physician will be in charge of prescribing it according to the individual clinical condition and the physical examination this will be recorded as Concomitant medication
Participants will
Be randomized into one of the 3 intervention groups ABC
Visit the clinic at day 0 day of enrollment and at day 7
Answer the first symptomatic related survey at the randomization visit V0 and the following ones in the morning when they wake up the last survey will be answered at the final visit day 7
In the event that the symptoms worsen or the patients clinical condition warrants the use of any additional medication the principal investigator or designated physician will be in charge of prescribing it according to the individual clinical condition and the physical examination this will be recorded as Concomitant medication
Participants will
Be randomized into one of the 3 intervention groups ABC
Visit the clinic at day 0 day of enrollment and at day 7
Answer the first symptomatic related survey at the randomization visit V0 and the following ones in the morning when they wake up the last survey will be answered at the final visit day 7
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