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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT00790998
Date of registration:	13/11/2008
Prospective Registration:	Yes
Primary sponsor:	Medicines Development for Global Health
Public title:	Study Comparing Moxidectin And Ivermectin In Subjects With Onchocerca Volvulus Infection
Scientific title:	A Single-Dose, Ivermectin-Controlled, Double-Blind, Efficacy, Safety And Tolerability Study Of Orally Administered Moxidectin In Subjects Infected With Onchocerca Volvulus
Date of first enrolment:	April 2009
Target sample size:	1497
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT00790998
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
Phase:	Phase 3

Countries of recruitment
Congo	Congo, The Democratic Republic of the	Ghana	Liberia

Contacts

Name:	Special Programme for Research and Training in Tropical Diseases (TDR)
Address:
Telephone:
Email:
Affiliation:	World Health Organization

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male and female subjects with Onchocerca volvulus infection

Exclusion Criteria:

- Pregnant or breast feeding women; coincidental loiasis

Age minimum: 12 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Onchocerciasis

Intervention(s)

Drug: Ivermectin

Drug: Moxidectin

Primary Outcome(s)

skin microfilaria density (mf/mg) [Time Frame: 12 months]

Secondary Outcome(s)

skin microfilaria density (mf/mg) [Time Frame: 18 months]

percent reduction in microfilaria levels in the anterior chamber of the eye [Time Frame: 12 months]

proportion of subjects with undetectable levels of skin microfilaria [Time Frame: 12 months]

proportion of subjects with undetectable levels of skin microfilaria [Time Frame: 6 months]

skin microfilaria reduction from baseline [Time Frame: 1 month]

proportion of subjects with undetectable levels of skin microfilaria [Time Frame: 1 month]

proportion of subjects with undetectable levels of skin microfilaria [Time Frame: 18 months]

skin microfilaria density (mf/mg) [Time Frame: 1 month]

skin microfilaria density (mf/mg) [Time Frame: 6 months]

skin microfilaria reduction from baseline [Time Frame: 12 months]

skin microfilaria reduction from baseline [Time Frame: 18 months]

skin microfilaria reduction from baseline [Time Frame: 6 months]

Secondary ID(s)

3110A1-3000

B1751006 - ONCBL60801

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

World Health Organization

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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