Back to results

Safety and Efficacy of Drug Combinations Against Schistosomiasis

Primary Purpose

Parasitic Diseases

Status

Completed

Phase

Not Applicable

Locations

Uganda

Study Type

Interventional

Intervention

albendazole + praziquantel

mebendazole + praziquantel

About this trial

This is an interventional treatment trial for Parasitic Diseases

Eligibility Criteria

1 Year - 15 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Vector Control Division

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Arm Description

albendazole + praziquantel

mebendazole + praziquantel

Outcomes

Primary Outcome Measures

Efficacy of treatment

Secondary Outcome Measures

Record of adverse reactions

Full Information

NCT ID

NCT01050374

First Posted

January 23, 2008

Last Updated

January 14, 2010

Sponsor

DBL -Institute for Health Research and Development

1. Study Identification

Unique Protocol Identification Number

NCT01050374

Brief Title

Safety and Efficacy of Drug Combinations Against Schistosomiasis

Official Title

Gaps in Helminth Control: Safety and Efficacy of Drug Combinations. Praziquantel Study

Study Type

Interventional

2. Study Status

Record Verification Date

January 2010

Overall Recruitment Status

Completed

Study Start Date

October 2007 (undefined)

Primary Completion Date

October 2008 (Actual)

Study Completion Date

October 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

DBL -Institute for Health Research and Development

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parasitic Diseases

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

650 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Placebo Comparator

Arm Description

albendazole + praziquantel

Arm Title

Arm Type

Active Comparator

Arm Description

mebendazole + praziquantel

Intervention Type

Drug

Intervention Name(s)

albendazole + praziquantel

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

mebendazole + praziquantel

Intervention Description

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

Primary Outcome Measure Information:

Title

Efficacy of treatment

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

Record of adverse reactions

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Year

Maximum Age & Unit of Time

15 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Vector Control Division

City

Kampala

Country

Uganda

12. IPD Sharing Statement

Learn more about this trial

Safety and Efficacy of Drug Combinations Against Schistosomiasis

We'll reach out to this number within 24 hrs