Trial Outcomes & Findings for Efficacy and Safety of Moxidectin-Albendazole Co-administration in SAC (NCT NCT06188715)
NCT ID: NCT06188715
Last Updated: 2025-09-19
Results Overview
The CR will be calculated as the proportion of participants converting from being egg-positive pre-treatment to egg-negative post-treatment.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
224 participants
Primary outcome timeframe
14-21 days post-treatment
Results posted on
2025-09-19
Participant Flow
Participant milestones
| Measure |
Arm A: Moxidectin 4/8 mg & Albendazole
Combination therapy of moxidectin (4 mg or 8 mg, i.e. 2 or 4 tablets of 2 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Moxidectin 2 mg Oral Tablet: Tablets of 2 mg moxidectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm B: Albendazole
Placebo for moxidectin (2 or 4 tablets) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
Placebo Moxidectin: Placebo tablets for moxidectin
|
Arm C: Placebo
Placebo for moxidectin (2 or 4 tablets) and placebo for albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Placebo Moxidectin: Placebo tablets for moxidectin
Placebo Albendazole: Placebo tablets for albendazole
|
|---|---|---|---|
|
Overall Study
STARTED
|
114
|
74
|
36
|
|
Overall Study
COMPLETED
|
111
|
68
|
34
|
|
Overall Study
NOT COMPLETED
|
3
|
6
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Arm A: Moxidectin 4/8 mg & Albendazole
n=114 Participants
Combination therapy of moxidectin (4 mg or 8 mg, i.e. 2 or 4 tablets of 2 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Moxidectin 2 mg Oral Tablet: Tablets of 2 mg moxidectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm B: Albendazole
n=74 Participants
Placebo for moxidectin (2 or 4 tablets) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
Placebo Moxidectin: Placebo tablets for moxidectin
|
Arm C: Placebo
n=36 Participants
Placebo for moxidectin (2 or 4 tablets) and placebo for albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Placebo Moxidectin: Placebo tablets for moxidectin
Placebo Albendazole: Placebo tablets for albendazole
|
Total
n=224 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
8.0 years
STANDARD_DEVIATION 1.2 • n=114 Participants
|
8.0 years
STANDARD_DEVIATION 1.4 • n=74 Participants
|
7.9 years
STANDARD_DEVIATION 1.2 • n=36 Participants
|
8.0 years
STANDARD_DEVIATION 1.3 • n=224 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=114 Participants
|
34 Participants
n=74 Participants
|
15 Participants
n=36 Participants
|
95 Participants
n=224 Participants
|
|
Sex: Female, Male
Male
|
68 Participants
n=114 Participants
|
40 Participants
n=74 Participants
|
21 Participants
n=36 Participants
|
129 Participants
n=224 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Tanzania
|
114 participants
n=114 Participants
|
74 participants
n=74 Participants
|
36 participants
n=36 Participants
|
224 participants
n=224 Participants
|
|
Trichuris trichiura infection intensity
Light infection (<1000 EPG)
|
86 Participants
n=114 Participants
|
56 Participants
n=74 Participants
|
27 Participants
n=36 Participants
|
169 Participants
n=224 Participants
|
|
Trichuris trichiura infection intensity
Moderate infection (1000-9999 EPG)
|
27 Participants
n=114 Participants
|
18 Participants
n=74 Participants
|
8 Participants
n=36 Participants
|
53 Participants
n=224 Participants
|
|
Trichuris trichiura infection intensity
Heavy infection (>9999 EPG)
|
1 Participants
n=114 Participants
|
0 Participants
n=74 Participants
|
1 Participants
n=36 Participants
|
2 Participants
n=224 Participants
|
|
Ascaris lumbricoides co-infection
|
38 Participants
n=114 Participants
|
18 Participants
n=74 Participants
|
11 Participants
n=36 Participants
|
67 Participants
n=224 Participants
|
|
Hookworm co-infection
|
53 Participants
n=114 Participants
|
27 Participants
n=74 Participants
|
14 Participants
n=36 Participants
|
94 Participants
n=224 Participants
|
PRIMARY outcome
Timeframe: 14-21 days post-treatmentPopulation: Available case population.
The CR will be calculated as the proportion of participants converting from being egg-positive pre-treatment to egg-negative post-treatment.
Outcome measures
| Measure |
Arm A: Moxidectin 4/8 mg & Albendazole
n=111 Participants
Combination therapy of moxidectin (4 mg or 8 mg, i.e. 2 or 4 tablets of 2 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Moxidectin 2 mg Oral Tablet: Tablets of 2 mg moxidectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm B: Albendazole
n=68 Participants
Placebo for moxidectin (2 or 4 tablets) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
Placebo Moxidectin: Placebo tablets for moxidectin
|
Arm C: Placebo
n=34 Participants
Placebo for moxidectin (2 or 4 tablets) and placebo for albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Placebo Moxidectin: Placebo tablets for moxidectin
Placebo Albendazole: Placebo tablets for albendazole
|
|---|---|---|---|
|
Cure Rate (CR) Against T. Trichiura
|
69.4 percentage of participants cured (%)
Interval 59.9 to 77.8
|
16.2 percentage of participants cured (%)
Interval 8.4 to 27.1
|
11.8 percentage of participants cured (%)
Interval 3.3 to 27.5
|
SECONDARY outcome
Timeframe: 14-21 days post-treatmentPopulation: Available case population.
Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs.
Outcome measures
| Measure |
Arm A: Moxidectin 4/8 mg & Albendazole
n=111 Participants
Combination therapy of moxidectin (4 mg or 8 mg, i.e. 2 or 4 tablets of 2 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Moxidectin 2 mg Oral Tablet: Tablets of 2 mg moxidectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm B: Albendazole
n=68 Participants
Placebo for moxidectin (2 or 4 tablets) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
Placebo Moxidectin: Placebo tablets for moxidectin
|
Arm C: Placebo
n=34 Participants
Placebo for moxidectin (2 or 4 tablets) and placebo for albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Placebo Moxidectin: Placebo tablets for moxidectin
Placebo Albendazole: Placebo tablets for albendazole
|
|---|---|---|---|
|
Egg Reduction Rate (ERR) Against T. Trichiura (Geometric Mean ERR)
|
99.1 percent change in egg counts (%)
Interval 98.6 to 99.5
|
64.4 percent change in egg counts (%)
Interval 42.9 to 78.3
|
14.6 percent change in egg counts (%)
Interval -28.3 to 46.5
|
SECONDARY outcome
Timeframe: 14-21 days post-treatmentPopulation: Available case population.
Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs.
Outcome measures
| Measure |
Arm A: Moxidectin 4/8 mg & Albendazole
n=111 Participants
Combination therapy of moxidectin (4 mg or 8 mg, i.e. 2 or 4 tablets of 2 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Moxidectin 2 mg Oral Tablet: Tablets of 2 mg moxidectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm B: Albendazole
n=68 Participants
Placebo for moxidectin (2 or 4 tablets) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
Placebo Moxidectin: Placebo tablets for moxidectin
|
Arm C: Placebo
n=34 Participants
Placebo for moxidectin (2 or 4 tablets) and placebo for albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Placebo Moxidectin: Placebo tablets for moxidectin
Placebo Albendazole: Placebo tablets for albendazole
|
|---|---|---|---|
|
Egg Reduction Rate (ERR) Against T. Trichiura (Arithmetic Mean ERR)
|
91.1 percent change in egg counts (%)
Interval 82.5 to 96.0
|
-12.9 percent change in egg counts (%)
Interval -121.5 to 51.5
|
-123.9 percent change in egg counts (%)
Interval -196.9 to -11.0
|
SECONDARY outcome
Timeframe: 14-21 days post-treatmentPopulation: Subset of participants co-infected with A. lumbricoides at baseline and providing follow-up data.
The CR will be calculated as the proportion of participants converting from being egg-positive pre-treatment to egg-negative post-treatment.
Outcome measures
| Measure |
Arm A: Moxidectin 4/8 mg & Albendazole
n=36 Participants
Combination therapy of moxidectin (4 mg or 8 mg, i.e. 2 or 4 tablets of 2 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Moxidectin 2 mg Oral Tablet: Tablets of 2 mg moxidectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm B: Albendazole
n=16 Participants
Placebo for moxidectin (2 or 4 tablets) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
Placebo Moxidectin: Placebo tablets for moxidectin
|
Arm C: Placebo
n=10 Participants
Placebo for moxidectin (2 or 4 tablets) and placebo for albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Placebo Moxidectin: Placebo tablets for moxidectin
Placebo Albendazole: Placebo tablets for albendazole
|
|---|---|---|---|
|
Cure Rate (CR) Against A. Lumbricoides
|
97.2 percentage of participants cured (%)
Interval 85.5 to 99.9
|
100.0 percentage of participants cured (%)
Interval 79.4 to 100.0
|
40.0 percentage of participants cured (%)
Interval 12.2 to 73.8
|
SECONDARY outcome
Timeframe: 14-21 days post-treatmentPopulation: Subset of participants co-infected with A. lumbricoides at baseline and providing follow-up data.
Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs.
Outcome measures
| Measure |
Arm A: Moxidectin 4/8 mg & Albendazole
n=36 Participants
Combination therapy of moxidectin (4 mg or 8 mg, i.e. 2 or 4 tablets of 2 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Moxidectin 2 mg Oral Tablet: Tablets of 2 mg moxidectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm B: Albendazole
n=16 Participants
Placebo for moxidectin (2 or 4 tablets) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
Placebo Moxidectin: Placebo tablets for moxidectin
|
Arm C: Placebo
n=10 Participants
Placebo for moxidectin (2 or 4 tablets) and placebo for albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Placebo Moxidectin: Placebo tablets for moxidectin
Placebo Albendazole: Placebo tablets for albendazole
|
|---|---|---|---|
|
Egg Reduction Rate (ERR) Against A. Lumbricoides (Geometric Mean ERR)
|
99.9 percent change in egg counts (%)
Interval 99.9 to 100.0
|
100.0 percent change in egg counts (%)
Interval 100.0 to 100.0
|
85.0 percent change in egg counts (%)
Interval 4.1 to 98.2
|
SECONDARY outcome
Timeframe: 14-21 days post-treatmentPopulation: Subset of participants co-infected with A. lumbricoides at baseline and providing follow-up data.
Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs.
Outcome measures
| Measure |
Arm A: Moxidectin 4/8 mg & Albendazole
n=36 Participants
Combination therapy of moxidectin (4 mg or 8 mg, i.e. 2 or 4 tablets of 2 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Moxidectin 2 mg Oral Tablet: Tablets of 2 mg moxidectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm B: Albendazole
n=16 Participants
Placebo for moxidectin (2 or 4 tablets) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
Placebo Moxidectin: Placebo tablets for moxidectin
|
Arm C: Placebo
n=10 Participants
Placebo for moxidectin (2 or 4 tablets) and placebo for albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Placebo Moxidectin: Placebo tablets for moxidectin
Placebo Albendazole: Placebo tablets for albendazole
|
|---|---|---|---|
|
Egg Reduction Rate (ERR) Against A. Lumbricoides (Arithmetic Mean ERR)
|
88.2 percent change in egg counts (%)
Interval 52.4 to 100.0
|
100.0 percent change in egg counts (%)
Interval 100.0 to 100.0
|
-17.5 percent change in egg counts (%)
Interval -134.0 to 23.4
|
SECONDARY outcome
Timeframe: 14-21 days post-treatmentPopulation: Subset of participants co-infected with hookworm at baseline and providing follow-up data.
The CR will be calculated as the proportion of participants converting from being egg-positive pre-treatment to egg-negative post-treatment.
Outcome measures
| Measure |
Arm A: Moxidectin 4/8 mg & Albendazole
n=53 Participants
Combination therapy of moxidectin (4 mg or 8 mg, i.e. 2 or 4 tablets of 2 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Moxidectin 2 mg Oral Tablet: Tablets of 2 mg moxidectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm B: Albendazole
n=26 Participants
Placebo for moxidectin (2 or 4 tablets) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
Placebo Moxidectin: Placebo tablets for moxidectin
|
Arm C: Placebo
n=13 Participants
Placebo for moxidectin (2 or 4 tablets) and placebo for albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Placebo Moxidectin: Placebo tablets for moxidectin
Placebo Albendazole: Placebo tablets for albendazole
|
|---|---|---|---|
|
Cure Rate (CR) Against Hookworm
|
83.0 percentage of participants cured (%)
Interval 70.2 to 91.9
|
65.4 percentage of participants cured (%)
Interval 44.3 to 82.8
|
7.7 percentage of participants cured (%)
Interval 0.2 to 36.0
|
SECONDARY outcome
Timeframe: 14-21 days post-treatmentPopulation: Subset of participants co-infected with hookworm at baseline and providing follow-up data.
Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs.
Outcome measures
| Measure |
Arm A: Moxidectin 4/8 mg & Albendazole
n=53 Participants
Combination therapy of moxidectin (4 mg or 8 mg, i.e. 2 or 4 tablets of 2 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Moxidectin 2 mg Oral Tablet: Tablets of 2 mg moxidectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm B: Albendazole
n=26 Participants
Placebo for moxidectin (2 or 4 tablets) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
Placebo Moxidectin: Placebo tablets for moxidectin
|
Arm C: Placebo
n=13 Participants
Placebo for moxidectin (2 or 4 tablets) and placebo for albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Placebo Moxidectin: Placebo tablets for moxidectin
Placebo Albendazole: Placebo tablets for albendazole
|
|---|---|---|---|
|
Egg Reduction Rate (ERR) Against Hookworm (Geometric Mean ERR)
|
99.3 percent change in egg counts (%)
Interval 98.6 to 99.7
|
97.8 percent change in egg counts (%)
Interval 94.4 to 99.3
|
-24.5 percent change in egg counts (%)
Interval -240.7 to 61.2
|
SECONDARY outcome
Timeframe: 14-21 days post-treatmentPopulation: Subset of participants co-infected with hookworm at baseline and providing follow-up data.
Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs.
Outcome measures
| Measure |
Arm A: Moxidectin 4/8 mg & Albendazole
n=53 Participants
Combination therapy of moxidectin (4 mg or 8 mg, i.e. 2 or 4 tablets of 2 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Moxidectin 2 mg Oral Tablet: Tablets of 2 mg moxidectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm B: Albendazole
n=26 Participants
Placebo for moxidectin (2 or 4 tablets) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
Placebo Moxidectin: Placebo tablets for moxidectin
|
Arm C: Placebo
n=13 Participants
Placebo for moxidectin (2 or 4 tablets) and placebo for albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Placebo Moxidectin: Placebo tablets for moxidectin
Placebo Albendazole: Placebo tablets for albendazole
|
|---|---|---|---|
|
Egg Reduction Rate (ERR) Against Hookworm (Arithmetic Mean ERR)
|
95.9 percent change in egg counts (%)
Interval 90.8 to 98.7
|
87.3 percent change in egg counts (%)
Interval 77.4 to 95.2
|
-113.0 percent change in egg counts (%)
Interval -244.3 to -11.8
|
SECONDARY outcome
Timeframe: 3 hours, 24 hours and 14-21 days post-treatmentPopulation: All participants receiving treatment.
Participants will be monitored at the site for 3 hours following treatment for any acute AEs and reassessment will be done at 24h post-treatment. In addition, participants will be interviewed 3 and 24 hours after treatment and retrospectively at days 14-21 about the occurrence of AEs.
Outcome measures
| Measure |
Arm A: Moxidectin 4/8 mg & Albendazole
n=114 Participants
Combination therapy of moxidectin (4 mg or 8 mg, i.e. 2 or 4 tablets of 2 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Moxidectin 2 mg Oral Tablet: Tablets of 2 mg moxidectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm B: Albendazole
n=74 Participants
Placebo for moxidectin (2 or 4 tablets) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
Placebo Moxidectin: Placebo tablets for moxidectin
|
Arm C: Placebo
n=36 Participants
Placebo for moxidectin (2 or 4 tablets) and placebo for albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Placebo Moxidectin: Placebo tablets for moxidectin
Placebo Albendazole: Placebo tablets for albendazole
|
|---|---|---|---|
|
Number of Participants Reporting Adverse Events (AEs)
14-21 days: Nausea
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants Reporting Adverse Events (AEs)
3 hours: Abdominal pain
|
4 participants
|
2 participants
|
1 participants
|
|
Number of Participants Reporting Adverse Events (AEs)
3 hours: Diarrhoea
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants Reporting Adverse Events (AEs)
3 hours: Nausea
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants Reporting Adverse Events (AEs)
3 hours: Vomiting
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants Reporting Adverse Events (AEs)
3 hours: Dizziness
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants Reporting Adverse Events (AEs)
3 hours: Headache
|
2 participants
|
0 participants
|
1 participants
|
|
Number of Participants Reporting Adverse Events (AEs)
24 hours: Abdominal pain
|
1 participants
|
0 participants
|
1 participants
|
|
Number of Participants Reporting Adverse Events (AEs)
24 hours: Diarrhoea
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants Reporting Adverse Events (AEs)
24 hours: Nausea
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants Reporting Adverse Events (AEs)
24 hours: Vomiting
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants Reporting Adverse Events (AEs)
24 hours: Dizziness
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants Reporting Adverse Events (AEs)
24 hours: Headache
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants Reporting Adverse Events (AEs)
14-21 days: Abdominal pain
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants Reporting Adverse Events (AEs)
14-21 days: Diarrhoea
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants Reporting Adverse Events (AEs)
14-21 days: Vomiting
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants Reporting Adverse Events (AEs)
14-21 days: Dizziness
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants Reporting Adverse Events (AEs)
14-21 days: Headache
|
0 participants
|
0 participants
|
0 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 0 to 24 hours post-treatmentFor characterization of population pharmacokinetics (PK), moxidectin concentration will be quantified using a validated liquid chromatography tandem mass spectrometry (LC-MS/MS) method. Drug concentrations will be calculated by interpolation from a calibration curve with a lower limit of quantification of 1-5 ng/ml.
Outcome measures
Outcome data not reported
Adverse Events
Arm A: Moxidectin 4/8 mg & Albendazole
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Arm B: Albendazole
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Arm C: Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm A: Moxidectin 4/8 mg & Albendazole
n=114 participants at risk
Combination therapy of moxidectin (4 mg or 8 mg, i.e. 2 or 4 tablets of 2 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Moxidectin 2 mg Oral Tablet: Tablets of 2 mg moxidectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
|
Arm B: Albendazole
n=74 participants at risk
Placebo for moxidectin (2 or 4 tablets) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
Placebo Moxidectin: Placebo tablets for moxidectin
|
Arm C: Placebo
n=36 participants at risk
Placebo for moxidectin (2 or 4 tablets) and placebo for albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Placebo Moxidectin: Placebo tablets for moxidectin
Placebo Albendazole: Placebo tablets for albendazole
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
4.4%
5/114 • Number of events 5 • 2-3 weeks
|
2.7%
2/74 • Number of events 2 • 2-3 weeks
|
2.8%
1/36 • Number of events 2 • 2-3 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/114 • 2-3 weeks
|
0.00%
0/74 • 2-3 weeks
|
2.8%
1/36 • Number of events 1 • 2-3 weeks
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/114 • 2-3 weeks
|
0.00%
0/74 • 2-3 weeks
|
2.8%
1/36 • Number of events 1 • 2-3 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/114 • 2-3 weeks
|
0.00%
0/74 • 2-3 weeks
|
2.8%
1/36 • Number of events 1 • 2-3 weeks
|
|
Nervous system disorders
Dizziness
|
0.88%
1/114 • Number of events 1 • 2-3 weeks
|
0.00%
0/74 • 2-3 weeks
|
2.8%
1/36 • Number of events 1 • 2-3 weeks
|
|
Nervous system disorders
Headache
|
1.8%
2/114 • Number of events 2 • 2-3 weeks
|
0.00%
0/74 • 2-3 weeks
|
2.8%
1/36 • Number of events 1 • 2-3 weeks
|
|
General disorders
Other
|
1.8%
2/114 • Number of events 2 • 2-3 weeks
|
1.4%
1/74 • Number of events 1 • 2-3 weeks
|
2.8%
1/36 • Number of events 1 • 2-3 weeks
|
Additional Information
Prof Jennifer Keiser
Swiss Tropical and Public Health Institute
Phone: +41 61 284 82 18
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place