Ignite Creation Date:
2024-05-06 @ 1:24 PM
Last Modification Date:
2024-10-26 @ 1:13 PM
Study NCT ID:
NCT04016051
Status:
COMPLETED
Last Update Posted:
2019-07-11
First Post:
2019-06-05
Brief Title:
Acceptance of Clarithromycin in a Straw Compared to Syrup in Children With Upper Respiratory Tract Infections
Sponsor:
Grünenthal GmbH
Organization:
Grünenthal GmbH
Study Overview
Official Title:
Comparison of Treatment Satisfaction and Treatment Adherence of a Novel Application Form Dose Sipping Technology DST of Oral Clarithromycin vs Clarithromycin Syrup in Children Suffering From Acute Otitis Media Tonsillitis Pharyngitis or Acute Bacterial Bronchitis DoSe iT
Status:
COMPLETED
Status Verified Date:
2019-07
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:
DoSe iT
Brief Summary:
This study was performed in children with upper respiratory tract infections acute ear infection infection of the tonsils or throat or bacterial inflammation of the bronchi who needed treatment with an antibiotic clarithromycin The study investigated a new technology which delivers the antibiotic in a straw dose sipping technology DST in comparison to a marketed syrup
Detailed Description:
The study population were children aged 2-12 years weight 12-40 kg suffering from upper respiratory tract infections acute otitis media tonsillitis pharyngitis or acute bacterial bronchitis and who needed antibiotic treatment The study compared treatment satisfaction and treatment adherence of oral clarithromycin DST 125 mg 1875 mg or 250 mg twice daily with the established oral clarithromycin syrup administered via a graduated syringe Klacid Syrup Forte 250 mg5mL at the same fixed daily doses
Fixed doses of 125 mg 1875 mg and 250 mg of clarithromycin DST offer the pediatrician the flexibility to treat children of different body weight and age adequately at the recommended daily dose of 15 125-20 mgkg All children were treated for 7 to 10 day 14 to 20 doses Treatment satisfaction by the guardiancaregiver in terms of handling and administration of the clarithromycin DST straw and the comparator clarithromycin syrup convenience of the administration acceptance of taste and aftertaste and treatment satisfaction with respect to future use was evaluated by means of a Parents Questionnaire once on either Day 3 4 or 5 and once on either Day 11 12 13 or 14 In addition treatment adherencewillingness of medication intake and the childs health status were assessed The safety program comprised recording and evaluation of adverse events and countermeasures
Fixed doses of 125 mg 1875 mg and 250 mg of clarithromycin DST offer the pediatrician the flexibility to treat children of different body weight and age adequately at the recommended daily dose of 15 125-20 mgkg All children were treated for 7 to 10 day 14 to 20 doses Treatment satisfaction by the guardiancaregiver in terms of handling and administration of the clarithromycin DST straw and the comparator clarithromycin syrup convenience of the administration acceptance of taste and aftertaste and treatment satisfaction with respect to future use was evaluated by means of a Parents Questionnaire once on either Day 3 4 or 5 and once on either Day 11 12 13 or 14 In addition treatment adherencewillingness of medication intake and the childs health status were assessed The safety program comprised recording and evaluation of adverse events and countermeasures
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?:
None