Safety and Efficacy of Drug Combinations Against Trichuris Trichiura

• Sponsor: DBL -Institute for Health Research and Development (Other)
• Overall Status: Completed
• CT.gov ID: NCT01050452
• Collaborator: (none)
• Enrollment: 750
• Location: 1
• Arms: 5
• Duration (Months): 22
• Patients Per Site Per Month: 34.1

Study Details

Study Description

Brief Summary

This randomised, controlled, double-blinded clinical study investigates the safety and efficacy of albendazole (ALB), mebendazole (MBD) and ivermectin (IVM) separately, and ALB and MBD each in combination with IVM in the treatment of Trichuris trichiura in children aged 5-14 years.

Condition or Disease	Intervention/Treatment	Phase
Parasitic Diseases	Drug: albendazole; Drug: mebendazole; Drug: ivermectin; Drug: albendazole + ivermectin; Drug: mebendazole + ivermectin	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 750 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. Study on Trichuris Trichiura.
• Study Start Date: Oct 1, 2007
• Actual Primary Completion Date: Aug 1, 2009
• Actual Study Completion Date: Aug 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: 1 albendazole treatment	Drug: albendazole; albendazole (400 mg on dose)
Active Comparator: 2 mebendazole treatment	Drug: mebendazole; mebendazole (500 mg one dose)
Active Comparator: 3 ivermectin treatment	Drug: ivermectin; ivermectin (200 microgram/kg body weight)
Active Comparator: 4 albendazole + ivermectin treatment	Drug: albendazole + ivermectin; albendazole (400 mg one dose) + ivermectin (200 mg microgram/kg body weight)
Active Comparator: 5 mebendazole + ivermectin treatment	Drug: mebendazole + ivermectin; mebendazole (500 mg one dose) + ivermectin (200 microgram/kg body weight)

Outcome Measures

Primary Outcome Measures

1. Record adverse reactions [6 weeks]

Secondary Outcome Measures

1. Efficacy of treatment [6 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 5 Years to 15 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Those who are enrolled in class one to six

• Are infected with T. trichiura

• Whose parent consent and who are willing to participate

Exclusion Criteria:

• Those with acute and chronic diseases other than T. trichiura

• Those with a history of any serious adverse drug reactions

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vector Control Division	Kampala		Uganda

Sponsors and Collaborators

• DBL -Institute for Health Research and Development

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01050452
• Other Study ID Numbers: AO.UGA.TRI; DBL-CHRD
• First Posted: Jan 15, 2010
• Last Update Posted: Jan 15, 2010
• Last Verified: Jan 1, 2010

• Additional relevant MeSH terms: Parasitic Diseases; Ivermectin; Albendazole; Mebendazole; Piperazine; Piperazine citrate; DMP 777

Study Results

No Results Posted as of Jan 15, 2010