CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 147 enrolled
Drug / intervention
oral rehydration solution Hipp ORS Apple 200 +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01467570
NCT01467570Phase 4Completed
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Efficacy and Safety of a New Oral Rehydration Solution (Hipp ORS 200 Apple) in Children With Acute Gastroenteritis: Randomized, Double-Blind Controlled Trial

Medical University of Warsaw·interventional·Posted Nov 8, 2011·Updated Apr 1, 2014

In Brief

A Phase 4 clinical trial evaluating oral rehydration solution Hipp ORS Apple 200 and ESPGHAN ORS for Diarrhea. Completed, enrolled 147 participants across 1 site.

Detailed Summary

It is generally recommended that oral rehydration should be used as first-line therapy to treat or prevent dehydration in children with acute gastroenteritis (AGE). Refusal to drink regular Oral Rehydration Solution (ORS) interfere with compliance with the recommended treatment. The objective of this study is to compare the tolerance, acceptance, efficacy and safety of a new ORS (Hipp ORS 200 Apple) of improved palatability with regular ORS recommended by ESPGHAN in children with acute gastroenteritis (AGE).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiarrhea
CountriesPoland
Collaborators--

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 8, 2011
Enrollment StartJun 1, 2009
Primary CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 14.7 years ago

Interventions

oral rehydration solution Hipp ORS Apple 200dietary

Volume of the solution calculated by weight: * fast oral rehydration in 3-4 hours by mouth * ORS given for ongoing losses until diarrhea stops (maintenance phase)

ESPGHAN ORSdietary

Volume of the solution calculated by weight: * fast oral rehydration in 3-4 hours by mouth * ORS given for ongoing losses until diarrhea stops (maintenance phase)