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 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:

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)


Ages Eligible for Study:   1 Year to 15 Years
Genders Eligible for Study:   Both
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
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

No publications provided

Responsible Party: Harriet Namwanje Principal Investigator, Vector control division, Ministry of Health 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
Trematode Infections
Piperazine citrate
Anticestodal Agents
Antiplatyhelmintic Agents
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 processed this record on April 17, 2014