NCT01050374

Brief Summary

This randomised, controlled, double-blinded clinical study investigates the safety and efficacy of MBD in combination with PZQ in the treatment of SCH and STH in children aged 1-15 years of age.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
650

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2007

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

January 15, 2010

Completed
Last Updated

January 15, 2010

Status Verified

January 1, 2010

Enrollment Period

1 year

First QC Date

January 23, 2008

Last Update Submit

January 14, 2010

Conditions

Parasitic Diseases

Outcome Measures

Primary Outcomes (1)

  • Efficacy of treatment

    6 weeks

Secondary Outcomes (1)

  • Record of adverse reactions

    6 weeks

Study Arms (2)

1

PLACEBO COMPARATOR

albendazole + praziquantel

Drug: albendazole + praziquantel

2

ACTIVE COMPARATOR

mebendazole + praziquantel

Drug: mebendazole + praziquantel

Interventions

albendazole + praziquantelDRUG

albendazole (400 mg one dose) + praziquantel (40 mg/kg body weight)

1
mebendazole + praziquantelDRUG

mebendazole (500 mg one dose) + praziquantel (40 mg/kg body weight)

2

Eligibility Criteria

Age1 Year - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Those with an age of 1-15 years of age
  • Are infected with schistosomiasis and soil-transmitted helminthiasis
  • Whose parent consent and who are willing to participate

You may not qualify if:

  • Those with acute and chronic diseases other than schistosomiasis and soil-transmitted helminthiasis
  • Those with a history of any serious adverse drug reactions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vector Control Division

Kampala, Uganda

Location

MeSH Terms

Conditions

Parasitic Diseases

Interventions

AlbendazolePraziquantelMebendazole

Condition Hierarchy (Ancestors)

Infections

Intervention Hierarchy (Ancestors)

CarbamatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsIsoquinolines

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 23, 2008

First Posted

January 15, 2010

Study Start

October 1, 2007

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

January 15, 2010

Record last verified: 2010-01

Locations

UG(1)