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Double-blind Study in Paediatric Epileptic to Compare the Subject Preference for ESL Suspension Formulation With Alternative Flavours

NCT02021461 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2014-04-03

Study results available
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Summary

The purpose of this study is to investigate the taste preference in children of 3 different flavours of the ESL oral suspension.

Conditions

Interventions

DRUG

ESL Banana taste

oral suspension with Banana flavor at a concentration of 50 mg/mL and was administered in 2.5 mL doses.

DRUG

ESL Grape taste

oral suspension with Grape flavor at a concentration of 50 mg/mL and was administered in 2.5 mL doses.

DRUG

ESL Tutti-Frutti taste

oral suspension with Tutti-Frutti flavor at a concentration of 50 mg/mL and was administered in 2.5 mL doses.

Sponsors & Collaborators

  • Bial - Portela C S.A.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
5 Years
Max Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • Romania
  • Slovakia

Study Locations

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Entities

Diseases

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 NCT02021461 on ClinicalTrials.gov