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Safety and Efficacy of Drug Combinations Against Schistosomiasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01050374
Recruitment Status : Completed
First Posted : January 15, 2010
Last Update Posted : January 15, 2010
Information provided by:
DBL -Institute for Health Research and Development

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.

Condition or disease Intervention/treatment
Parasitic Diseases Drug: albendazole + praziquantel Drug: mebendazole + praziquantel

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 650 participants
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
Study Start Date : October 2007
Primary Completion Date : October 2008
Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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)

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

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

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01050374

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

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
First Posted: January 15, 2010    Key Record Dates
Last Update Posted: January 15, 2010
Last Verified: January 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