Safety and Efficacy of Drug Combinations Against Schistos... | NCT01050374

Studies
Safety and Efficacy of Drug Combinations Against Schistosomiasis

NCT01050374

Sponsor

DBL -Institute for Health Research and Development

Status

Completed

Last Update Posted

Jan 15, 2010Estimated

Enrollment

650Estimated

Phase

Not Applicable

Conditions

Parasitic Diseases

Interventions

albendazole + praziquantel
mebendazole + praziquantel

Countries

Uganda

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
DBL-CHRD

Status Module

Record Verification Date

Jan 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2007

Primary Completion Date

Oct 2008Actual

Completion Date

Oct 2008Actual

First Submitted Date

Jan 23, 2008

First Submission Date that Met QC Criteria

Jan 14, 2010

First Posted Date

Jan 15, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 14, 2010

Last Update Posted Date

Jan 15, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

650Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Placebo Comparator	albendazole + praziquantel	Drug: albendazole + praziquantel
2	Active Comparator	mebendazole + praziquantel	Drug: mebendazole + praziquantel

Interventions

Name	Type	Description	Arm Group Labels	Other Names
albendazole + praziquantel	Drug	albendazole (400 mg one dose) + praziquantel (40 mg/kg body weight)	1

Measure	Description	Time Frame
Efficacy of treatment		6 weeks

Measure	Description	Time Frame
Record of adverse reactions		6 weeks

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

15 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vector Control Division		Kampala			Uganda

ID	Term
D010272	Parasitic Diseases

ID	Term
D007239	Infections

Intervention Browse Module

MeSH Terms

ID	Term
D015766	Albendazole
D011223	Praziquantel
D008463	Mebendazole

Ancestor Terms

ID	Term
D002219	Carbamates
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided