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Clinical Trial in Children Between 3 Months and 14 Years Old to Evaluate the Efficacy and Safety of Gelatin Tannate in the Treatment of Acute Diarrhea (INDIGO)

NCT04065529 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2020-11-04

No results posted yet for this study

Summary

To evaluate the safety, global efficacy and rapidity of action of GT in children with acute gastroenteritis taking ORS solution.

Conditions

Interventions

COMBINATION_PRODUCT

Gelatin tannate (GT) + oral rehydration solution (ORS) + Zinc supplementation

Gelatin tannate (GT) + oral rehydration solution (ORS) + Zinc supplementation

COMBINATION_PRODUCT

placebo + ORS + Zinc supplementation

placebo + ORS + Zinc supplementation

Sponsors & Collaborators

  • Axonal-Biostatem

    collaborator INDUSTRY

  • Ferrer Internacional S.A.

    lead INDUSTRY

Principal Investigators

  • Aldiouma Diallo, MS · IRD Senegal (Niakhar Center IRD BP 1386 Hann Mariste, CP 18524 Dakar. Sénégal.

  • Javier Xllop · Noventure SL

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
3 Months
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-11
Primary Completion
2020-06-11
Completion
2020-06-11

Countries

  • Senegal

Study Locations

More Related Trials

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 NCT04065529 on ClinicalTrials.gov