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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02078024 |
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Date of registration:
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28/02/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Efficacy of Ivermectin and Albendazole Against Onchocerciasis in the Volta Region, Ghana
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Scientific title:
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Comparison of Ivermectin Alone With Albendazole (ALB) Plus Ivermectin (IVM) in Their Efficacy Against Onchocerciasis in the Volta Region, Ghana. |
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Date of first enrolment:
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June 2014 |
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Target sample size:
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375 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02078024 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Factorial Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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Ghana
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Contacts
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Name:
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Christopher L King, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Case Western Reserve University |
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Name:
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James W Kazura, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Case Western Reserve University |
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Name:
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Nicholas O Opoku, MBChB, MSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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Municipal Hospital, Hohoe, Ghana |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Men and women 18-60 years residing along the Kpassa in the Nkwanta North District of
the Volta Region in Ghana
2. Two or more assessable onchocercal nodules
3. Skin microfilaria density =5mf/mg.
Exclusion Criteria:
1. Prior treatment with the antifilarial and/or anti-nematodal drugs diethylcarbamazine,
suramin, ivermectin, albendazole, levamisole or >1week of treatment with doxycycline,
within 12 months before planned test article administration.
2. Pregnant or breastfeeding women.
3. Low probability of residency in the area (based on subject's assessment) over the next
36 months.
4. Permanent disability, serious medical illnesses such as a stroke, advanced heart
disease, uncontrolled diabetes, emphysema, etc. that prevents or impedes study
participation and/or comprehension
5. Weight of <40kg suggesting malnourishment
6. Hemoglobin levels <7 gm/dL
7. aspartate aminotransferase, alanine aminotransferase, creatinine > 1.5 upper limit of
normal.
8. Significant glycosuria or proteinuria (2+ or 3+ protein or glucose).
9. Known or suspected allergy to albendazole or ivermectin or other compounds related to
these classes of medication.
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Onchocerciasis
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Intervention(s)
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Drug: IVM
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Drug: IVM plus ALB
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Primary Outcome(s)
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parasitologic efficacy
[Time Frame: 36 months]
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Secondary Outcome(s)
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additional measures of parasitologic efficacy
[Time Frame: 0, 6, 12, 18, 24 and 36 months]
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compare the percentage living versus dead female worms
[Time Frame: 36 months]
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compare the number of nodules with intact microfilaria
[Time Frame: 36 months]
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determine if IVM plus ALB enhances immunological reactions
[Time Frame: 0, 6, 12, 18, 24 and 36 months]
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assess different treatment regimens on Soil Transmitted Helminth infections
[Time Frame: 0, 6, 12, 18, 24 and 36 months]
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determine if the host immune response facilitates killing or sterilizing adult worms and microfilariae
[Time Frame: 0, 6, 12, 18, 24 and 36 months]
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Secondary ID(s)
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CWRU-OCR-1
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WU-10-205
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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