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Safety and Efficacy of Drug Combinations Against Schistosomiasis

This study has been completed.
Sponsor:
Information provided by:
DBL -Institute for Health Research and Development
ClinicalTrials.gov Identifier:
NCT01050374
First received: January 23, 2008
Last updated: January 14, 2010
Last verified: January 2010
History of Changes
  Purpose

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.


Condition Intervention
Parasitic Diseases
 Drug: albendazole + praziquantel
Drug: mebendazole + praziquantel

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Gaps in Helminth Control: Safety and Efficacy of Drug Combinations. Praziquantel Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by DBL -Institute for Health Research and Development:

Primary Outcome Measures:
  • Efficacy of treatment [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Record of adverse reactions [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 650
Study Start Date: October 2007
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
albendazole + praziquantel
 Drug: albendazole + praziquantel
albendazole (400 mg one dose) + praziquantel (40 mg/kg body weight)
Active Comparator: 2
mebendazole + praziquantel
 Drug: mebendazole + praziquantel
mebendazole (500 mg one dose) + praziquantel (40 mg/kg body weight)

  Eligibility

Ages Eligible for Study:   1 Year to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01050374

Locations
Uganda
Vector Control Division
Kampala, Uganda
Sponsors and Collaborators
DBL -Institute for Health Research and Development
  More Information

No publications provided

Responsible Party: Harriet Namwanje Principal Investigator, Vector control division, Ministry of Health
ClinicalTrials.gov Identifier: NCT01050374     History of Changes
Other Study ID Numbers: AO.UGA.PZQ, DBL-CHRD
Study First Received: January 23, 2008
Last Updated: January 14, 2010
Health Authority: Uganda: Ministry of Health

Additional relevant MeSH terms:
Parasitic Diseases
Schistosomiasis
Trematode Infections
Helminthiasis
Albendazole
Mebendazole
Piperazine
Piperazine citrate
Praziquantel
Anticestodal Agents
Antiplatyhelmintic Agents
Anthelmintics
 Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antiprotozoal Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antinematodal Agents

ClinicalTrials.gov processed this record on May 16, 2013