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OnchocerciasisPhase 3NCT00790998

Study Comparing Moxidectin And Ivermectin In Subjects With Onchocerca Volvulus Infection

A Phase 3 study testing Moxidectin and Ivermectin in people with Onchocerciasis, run by Medicines Development for Global Health at 4 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a Phase 3 study comparing the efficacy, safety and tolerability of moxidectin and ivermectin in subjects infected with Onchocerca volvulus, which is the parasite that causes river blindness. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Onchocerciasis
What is being tested?
Moxidectin and Ivermectin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,497 participants
Where
4 sitesin 3 countries
Study dates
Apr 2009to May 2012
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Male and female subjects with Onchocerca volvulus infection

Who cannot join

  • Pregnant or breast feeding women; coincidental loiasis

Trial locations and contacts

4 sites in 3 countries.

4 sites in 3 countries

Democratic Republic of the Congo2 sites

  • Centre de Recherche Clinique de Butembo - Université Catholique du Graben

    Butembo

  • Centre de Recherche en Maladies Tropicales de l'Ituri

    Rethy

Other trials in Democratic Republic of the Congo

Ghana1 site

  • Onchocerciasis Chemotherapy Research Center

    Hohoe

Other trials in Ghana

Liberia1 site

  • Liberian Institute for Biomedical Research Clinical Research Center

    Bolahun, Lofa County

Other trials in Liberia

About this study

Official title: A Single-Dose, Ivermectin-Controlled, Double-Blind, Efficacy, Safety And Tolerability Study Of Orally Administered Moxidectin In Subjects Infected With Onchocerca Volvulus

This is a Phase 3 study comparing the efficacy, safety and tolerability of moxidectin and ivermectin in subjects infected with Onchocerca volvulus, which is the parasite that causes river blindness. Subjects participating in the study will be randomly assigned (by a 2 to1 ratio) to receive one orally-administered dose of either moxidectin or ivermectin.

Conditions
Onchocerciasis
Being tested
Moxidectin, Ivermectin
Keywords
onchocerciasis, river blindness, onchocerca volvulus, moxidectin, ivermectin
Medical subject headings
Onchocerciasis, Onchocerciasis, Ocular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MoxidectinDrug

    Single dose of moxidectin 2 mg oral tablet x 4

  • IvermectinDrug

    Also called Ivermectin, Mectizan, Stromectol

    Single dose of ivermectin 3 mg oral tablet x 2, 3 or 4

Study groups in NCT00790998
Study groupRoleWhat they receive
MoxidectinExperimentalMoxidectin 8mg
Receives: Drug: Moxidectin
IvermectinActive comparatorIvermectin 150 mcg/kg
Receives: Drug: Ivermectin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. skin microfilaria density (mf/mg)

    Measured: 12 months

Secondary outcomes (12)

  1. skin microfilaria density (mf/mg)

    Measured: 1 month

  2. skin microfilaria density (mf/mg)

    Measured: 6 months

  3. skin microfilaria density (mf/mg)

    Measured: 18 months

  4. skin microfilaria reduction from baseline

    Measured: 1 month

  5. skin microfilaria reduction from baseline

    Measured: 6 months

  6. skin microfilaria reduction from baseline

    Measured: 12 months

  7. skin microfilaria reduction from baseline

    Measured: 18 months

  8. proportion of subjects with undetectable levels of skin microfilaria

    Measured: 1 month

  9. proportion of subjects with undetectable levels of skin microfilaria

    Measured: 6 months

  10. proportion of subjects with undetectable levels of skin microfilaria

    Measured: 12 months

  11. proportion of subjects with undetectable levels of skin microfilaria

    Measured: 18 months

  12. percent reduction in microfilaria levels in the anterior chamber of the eye

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Nov 2008 (estimated)
  2. Study startApr 2009
  3. Primary completionFeb 2012
  4. Study completionMay 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,497 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00790998
Sponsor's protocol ID
3110A1-3000
Other IDs
B1751006 - ONCBL60801
Status last verified
Nov 2013
First submitted
13 Nov 2008
Last updated
31 Jan 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • Opoku NO, Bakajika DK, Kanza EM, Howard H, Mambandu GL, Nyathirombo A, Nigo MM, Kasonia K, Masembe SL, Mumbere M, Kataliko K, Larbelee JP, Kpawor M, Bolay KM, Bolay F, Asare S, Attah SK, Olipoh G, Vaillant M, Halleux CM, Kuesel AC. Single dose moxidectin versus ivermectin for Onchocerca volvulus infection in Ghana, Liberia, and the Democratic Republic of the Congo: a randomised, controlled, double-blind phase 3 trial. Lancet. 2018 Oct 6;392(10154):1207-1216. doi: 10.1016/S0140-6736(17)32844-1. Epub 2018 Jan 18.

    PubMed 29361335

  • Bakajika D, Kanza EM, Opoku NO, Howard HM, Mambandu GL, Nyathirombo A, Nigo MM, Kennedy KK, Masembe SL, Mumbere M, Kataliko K, Bolay KM, Attah SK, Olipoh G, Asare S, Vaillant M, Halleux CM, Kuesel AC. Effect of a single dose of 8 mg moxidectin or 150 mug/kg ivermectin on O. volvulus skin microfilariae in a randomized trial: Differences between areas in the Democratic Republic of the Congo, Liberia and Ghana and impact of intensity of infection. PLoS Negl Trop Dis. 2022 Apr 27;16(4):e0010079. doi: 10.1371/journal.pntd.0010079. eCollection 2022 Apr.

    PubMed 35476631

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Moxidectin and Ivermectin in people with Onchocerciasis, run by Medicines Development for Global Health at 4 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Democratic Republic of the Congo, Ghana, Liberia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

skin microfilaria density (mf/mg) (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00790998, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2018.

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