NCT00352716

Brief Summary

The purpose of this study is to evaluate the effectiveness of Smecta at decreasing stool weight, when compared to placebo, in the treatment of acute diarrhoea in children.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jun 2006

Shorter than P25 for phase_3

Geographic Reach
1 country

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 13, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 17, 2006

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
Last Updated

November 22, 2019

Status Verified

November 1, 2019

Enrollment Period

8 months

First QC Date

July 13, 2006

Last Update Submit

November 21, 2019

Conditions

Diarrhoea

Outcome Measures

Primary Outcomes (1)

  • Cumulative faecal output (g/kg of body weight)

    72 hours after first study drug intake

Secondary Outcomes (8)

  • Cumulative faecal output (g)

    72 hours after first study drug intake

  • Faecal output (g/kg of body weight) per day

    72 hours after first study drug intake

  • Duration of watery diarrhoea (time of first study drug intake to watery diarrhoea disappearance)

    7 days after first study drug intake

  • Percentage of children withdrawn from the study due to IV rehydration (according to WHO guideline)

    7 days after first study drug intake

  • Percentage of body weight gain at H72 and Day 7 in comparison with body weight at inclusion

    Till 7 days after the first study drug intake

  • +3 more secondary outcomes

Interventions

Smecta (Diosmectite), duration of treatment - 7 daysDRUG

Eligibility Criteria

Age1 Month - 36 Months
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • male
  • acute watery diarrhoea defined as at least 3 watery stools per 24 hours
  • duration of watery diarrhoea of less than 72 hours and with at least one watery stool during the last 12 hours
  • dehydration signs requiring oral rehydration according to current WHO guidelines

You may not qualify if:

  • severe dehydration that needs IV therapy
  • presence of gross blood in stools
  • fever \> 39 degrees Celsius
  • current treatment by an antidiarrheal medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Instituto Especializado de Salud del Niño

Breña, Peru

Location

Hospital de Vitarte

Cercado, Peru

Location

Hospital General de Huacho

Huacho, Peru

Location

Hospital Regional de Ica

Ica, Peru

Location

Hospital Nacional Hipólato Unanue

La Molina, Peru

Location

Clinica San Juan Bautista

Lima, Peru

Location

Clinica San Pablo Sede Norte

Lima, Peru

Location

Hospital Municipal Los Olivos

Lima, Peru

Location

Hospital San Bartolomé

Lima, Peru

Location

Hospital San Juan de Lurigancho

Lima, Peru

Location

Hospital Nacional Cayetano Heredia

San Borga, Peru

Location

Hospital Nacional Daniel Alcides Carrión

San Miguel, Peru

Location

Hospital Emergencias Pediátricas

Zárate, Peru

Location

MeSH Terms

Conditions

Diarrhea

Interventions

smectaSmectiteDuration of Therapy

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Ipsen Medical Director

    Ipsen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2006

First Posted

July 17, 2006

Study Start

June 1, 2006

Primary Completion

February 1, 2007

Study Completion

February 1, 2007

Last Updated

November 22, 2019

Record last verified: 2019-11

Locations

PE(13)