NCT00352989

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
302

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jul 2006

Shorter than P25 for phase_3

Geographic Reach
1 country

19 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

July 1, 2006

Completed
12 days 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
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 24, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 24, 2007

Completed
Last Updated

November 22, 2019

Status Verified

November 1, 2019

Enrollment Period

9 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 the first study drug intake

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

    72 hours after the first study drug intake

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

    7 days after the first study drug intake

  • Percentage of children withdrawn from the study due to IV rehydration (according to WHO guideline)

    7 days after the first study drug intake

  • Percentage of body weight gain 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 1 watery stool for 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Kluang Hospital

Kluang, Johor, 86000, Malaysia

Location

Kajang Hospital

Jalan Semenyih, Kajang, 43000, Malaysia

Location

Kulim Hospital

Jalan Mahang, Kedah, 09000, Malaysia

Location

Temerloh Hospital

Hospital Sultan Haji Ahmad Shah, Pahang, 28000, Malaysia

Location

Seri Manjung Hospital

Seri Manjung, Perak, 28000, Malaysia

Location

Teluk Intan Hospital

Teluk Intan, Perak, 36000, Malaysia

Location

Alor Setar Hospital

Alor Setar Kedah, 05100, Malaysia

Location

Ipoh Hospital

Ipoh - Perak, 30990, Malaysia

Location

Raja Perempuan Zainab II Hospital

Kelantan, 15000, Malaysia

Location

Tengku Ampuan Rahimah Hospital

Kuala Selangor, 41200, Malaysia

Location

Serdang Hospital

Kuala Selangor, 43300, Malaysia

Location

Kuala Terengganu Hospital

Kuala Terengganu, 20400, Malaysia

Location

Tengku Ampuan Afzan Hospital

Kuantan Pahang, 25100, Malaysia

Location

Sarawak General Hospital

Kuching, 93586, Malaysia

Location

Malacca Hospital

Malacca, 75400, Malaysia

Location

Tuanku Jaafar Hospital

Negeri Sembilan, 70300, Malaysia

Location

Pulau Pinang Hospital

Pulau Pinang, 10450, Malaysia

Location

Sungai Petani Hospital

Sungai Petani, 08000, Malaysia

Location

Taiping Hospital

Taiping Perak, 34000, Malaysia

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

Study Record Dates

First Submitted

July 13, 2006

First Posted

July 17, 2006

Study Start

July 1, 2006

Primary Completion

March 24, 2007

Study Completion

March 24, 2007

Last Updated

November 22, 2019

Record last verified: 2019-11

Locations

MY(19)