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Acceptance of Clarithromycin in a Straw Compared to Syrup in Children With Upper Respiratory Tract Infections

NCT04016051 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 265

Last updated 2019-07-11

No results posted yet for this study

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.

Conditions

  • Otitis Media
  • Tonsillitis
  • Pharyngitis
  • Bronchitis

Interventions

DRUG

Clarithromycin DST (125 mg)

Clarithromycin DST (125.0 mg clarithromycin / straw).

DRUG

Clarithromycin DST (187.5 mg)

Clarithromycin DST (187.5 mg clarithromycin / straw).

DRUG

Clarithromycin DST (250 mg)

Clarithromycin DST (250.0 mg clarithromycin / straw).

DRUG

Clarithromycin Syrup (125 mg)

Clarithromycin Syrup 2.5 ml (125 mg).

DRUG

Clarithromycin Syrup (187.5 mg)

Clarithromycin Syrup 3.75 ml (187.5 mg).

DRUG

Clarithromycin Syrup (250 mg)

Clarithromycin Syrup 5 ml (250 mg).

Sponsors & Collaborators

  • Grünenthal GmbH

    lead INDUSTRY

Principal Investigators

  • Grünenthal Study Director · Grünenthal GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-09-22
Primary Completion
2004-12-23
Completion
2004-12-23

Countries

  • Germany
  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04016051 on ClinicalTrials.gov