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Safety and Efficacy of Drug Combinations Against Schistosomiasis

This study has been completed.
Information provided by:
DBL -Institute for Health Research and Development Identifier:
First received: January 23, 2008
Last updated: January 14, 2010
Last verified: January 2010
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 (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Gaps in Helminth Control: Safety and Efficacy of Drug Combinations. Praziquantel Study

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Efficacy of treatment [ Time Frame: 6 weeks ]

Secondary Outcome Measures:
  • Record of adverse reactions [ Time Frame: 6 weeks ]

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)


Ages Eligible for Study:   1 Year to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01050374

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

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

Additional relevant MeSH terms:
Parasitic Diseases
Piperazine citrate
Antiparasitic Agents
Anti-Infective Agents
Anticestodal Agents
Antiplatyhelmintic Agents
Antiprotozoal Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antinematodal Agents processed this record on September 20, 2017