ISRCTN45231833 - Clinical trials of drugs for onchocerciasis: a randomised, single-ascending-dose, ivermectin-controlled, double-blind, safety, tolerability, pharmacokinetic, and efficacy study of orally administered moxidectin in subjects with onchocerca volvulus infection (Ghana)

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20 May 2013

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Clinical trials of drugs for onchocerciasis: a randomised, single-ascending-dose, ivermectin-controlled, double-blind, safety, tolerability, pharmacokinetic, and efficacy study of orally administered moxidectin in subjects with onchocerca volvulus infection (Ghana)

ISRCTN	ISRCTN45231833
DOI	10.1186/ISRCTN45231833
ClinicalTrials.gov identifier	NCT00300768
EudraCT number
Public title	Clinical trials of drugs for onchocerciasis: a randomised, single-ascending-dose, ivermectin-controlled, double-blind, safety, tolerability, pharmacokinetic, and efficacy study of orally administered moxidectin in subjects with onchocerca volvulus infection (Ghana)
Scientific title
Acronym	N/A
Serial number at source	980819 (B)
Study hypothesis	Orally administered moxidectin is safe and well tolerated in subjects infected with Onchocerca volvulus and leads to long term suppression of skin microfilaria. Added 11/08/2008: This trial completed recruitment on the 30th June 2008. The end of follow-up is expected for 31st December 2009, and the below end date has been changed to reflect this. The previous anticipated end date of this trial was 01/09/2009. As of 03/12/2009 this record was updated to include the actual end date of participant follow-up; the previous anticipated end date was 31/12/2009.
Lay summary
Ethics approval	Ethics approval received from: 1. Ghana Health Service Ethical Review Committee (last approval date 24 August 2006) 2. World Health Organization (WHO) Ethics Review Committee (last approval date 28 June 2006)
Study design	Randomised, single ascending dose, active-control, double blind trial
Countries of recruitment	Ghana
Disease/condition/study domain	Onchocerciasis
Participants - inclusion criteria	1. Ivermectin-naïve men and women otherwise healthy, with O. volvulus infection 2. Informed consent 3. Aged 18 to 60 years 4. Body weight more than or equal to 40 kg for women, or more than or equal to 45 kg for men 5. Non-pregnant, non-lactating, willing to use contraception during the first 150 days after treatment 6. Normal medical history, physical examination, Electrocardiogram (ECG) and lab results 7. Adequate hematologic, renal and hepatic functions 8. Skin microfilarial density within the required range for the cohort
Participants - exclusion criteria	1. Participation in any studies other than purely observational ones within four weeks before test article administration 2. Any vaccination within four weeks before test article administration 3. Acute infection requiring therapy within the last ten days before test article administration 4. Any medication (with the exception of medication required to treat any reactions during the screening fluorescein angiography (chlorpheniramine) or paracetamol) or herbal preparation within ten days prior to test article administration or any condition currently requiring regular medication 5. History of drug or alcohol abuse or regular use of more than three cigarettes/day, use of alcohol or other drugs of abuse within 72 hours before test article administration 6. Blood donation within eight weeks before study entry 7. Clinically significant ECG abnormalities, or history of cardiac abnormalities, or past or current history of neurological or neuropsychiatric disease or epilepsy 8. Ocular onchocerciasis 9. Hyperactive onchodermatitis 10. Antifilaria therapy within previous five years 11. Coincidental infection with Loa Loa 12. Orthostatic hypotension 13. Female patient with contraindication to DepoMedroxyProgesterone Acetate (DMPA) if not on Norplant
Anticipated start date	01/09/2006
Anticipated end date	29/11/2009
Status of trial	Completed
Patient information material
Target number of participants	192
Interventions	Single dose of moxidectin of 2 mg, 4 mg or 8 mg, or ivermectin at the approved dose.
Primary outcome measure(s)	Data on safety and tolerability of a single oral dose of moxidectin (2, 4, or 8 mg).
Secondary outcome measure(s)	Skin microfilaria levels up to 18 months post treatment.
Sources of funding	United Nations Children's Fund (UNICEF)/United Nations Development Programme (UNDP)/World Bank/World Health Organization (WHO) - Special Programme for Research and Training in Tropical Diseases (TDR)
Trial website
Publications
Contact name	Dr A C Kuesel
Address	World Health Organization 20 Avenue Appia
City/town	Geneva -27
Zip/Postcode	CH 1211
Country	Switzerland
Email	kuesela@who.int
Sponsor	UNICEF/UNDP/World Bank/WHO - Special Programme for Research and Training in Tropical Diseases (TDR)
Address	World Health Organization 20 Avenue Appia
City/town	Geneva-27
Zip/Postcode	CH 1211
Country	Switzerland
Sponsor website:	http://www.who.int
Date applied	15/04/2005
Last edited	03/12/2009
Date ISRCTN assigned	07/06/2005


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