Safety and Efficacy of Drug Combinations Against Schistosomiasis

NCT ID: NCT01050374

Last Updated: 2010-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

650 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2008-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Parasitic Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

albendazole + praziquantel

Group Type PLACEBO_COMPARATOR

albendazole + praziquantel

Intervention Type DRUG

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

2

mebendazole + praziquantel

Group Type ACTIVE_COMPARATOR

mebendazole + praziquantel

Intervention Type DRUG

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

Interventions

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albendazole + praziquantel

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

Intervention Type DRUG

mebendazole + praziquantel

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

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

1 Year

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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DBL -Institute for Health Research and Development

OTHER

Sponsor Role lead

Responsible Party

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Vector control division, Ministry of Health

Locations

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Vector Control Division

Kampala, , Uganda

Site Status

Countries

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Uganda

Other Identifiers

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DBL-CHRD

Identifier Type: -

Identifier Source: secondary_id

AO.UGA.PZQ

Identifier Type: -

Identifier Source: org_study_id

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