Trial · NCT03527745
Albendazole Dose Finding and Pharmacokinetics in Children and Adults
NCT03527745, Phase 2, Completed, Jennifer Keiser; results first posted 2021-01-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Albendazole Dose Finding and Pharmacokinetics in Children and Adults. Trials, record NCT03527745. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03527745
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Albendazole Dose Finding and Pharmacokinetics in Children and Adults
- NCT number
- NCT03527745
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 700 participants, actual
- Lead sponsor
- Jennifer Keiser
- Conditions
- Trichuriasis, Hookworm Infections
- Interventions
- Albendazole, Albendazole, Albendazole, Albendazole, Placebo
- First posted
- 2018-05-17
- Last updated
- 2023-06-12
- Results first posted
- 2021-01-06
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cure Rate Against T. Trichiura and Hookworm Infections | 14-21 days after treatment | The conversion from being egg positive pre-treatment to egg negative post-treatment, or cure rate (CR). |
| Secondary | Egg-reduction Rate (ERR) Against T. Trichiura and Hookworm Infections, Respectively | 14-21 days after treatment | Percent change in geometric mean eggs per gram of stool from before to after treatment |
| Secondary | Maximum Concentration (Cmax) of Albendazole Sulphoxide | 0, 1, 2, 3, 4, 6, 8, 24 hours post-dosing | To determine maximum drug concentration (Cmax) of albendazole and its metabolites in adults (≥ 21 years), preschool-aged (2-5 years) and school-aged children (6-12 years). Albendazole sulfoxide 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 foreseen limit of quantification of approximately 1-5 ng/ml. |
| Secondary | Time to Reach Cmax (Tmax) of Albendazole Sulphoxide | 0, 1, 2, 3, 4, 6, 8, 24 hours post-dosing | To determine time to reach Cmax (tmax) of albendazole and its metabolites in adults (≥ 21 years), preschool-aged (2-5 years) and school-aged children (6-12 years). Albendazole sulfoxide was 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 foreseen limit of quantification of approximately 1-5 ng/ml. |
| Secondary | Area Under the Curve (AUC) of Albendazole Sulphoxide | 0, 1, 2, 3, 4, 6, 8, 24 hours post-dosing | To determine the area under the curve (AUC) of albendazole sulphoxide in adults (≥ 21 years), preschool-aged (2-5 years) and school-aged children (6-12 years). Albendazole and its metabolites (albendazole sulfoxide and albendazole sulfone) 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 foreseen limit of quantification of approximately 1-5 ng/ml. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Cure Rate Against T. Trichiura and Hookworm Infections | 14-21 days after treatment | An analysis set of all randomized participants who provided any follow-up data was used to perform an available-case analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Egg-reduction Rate (ERR) Against T. Trichiura and Hookworm Infections, Respectively | 14-21 days after treatment | An analysis set of all randomized participants who provided any follow-up data was used to perform an available-case analysis. | percent change | GEOMETRIC_MEAN |
| SECONDARY | Maximum Concentration (Cmax) of Albendazole Sulphoxide | 0, 1, 2, 3, 4, 6, 8, 24 hours post-dosing | mikromol/L | MEAN | |
| SECONDARY | Time to Reach Cmax (Tmax) of Albendazole Sulphoxide | 0, 1, 2, 3, 4, 6, 8, 24 hours post-dosing | hours | MEAN | |
| SECONDARY | Area Under the Curve (AUC) of Albendazole Sulphoxide | 0, 1, 2, 3, 4, 6, 8, 24 hours post-dosing | micogram/ml/h-1 | MEAN |
Source ClinicalTrials.gov
Results by group135
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Cure Rate Against T. Trichiura and Hookworm Infections | Placebo Against T. Trichiura in PSAC | Cured | 4 | Participants | |
| Cure Rate Against T. Trichiura and Hookworm Infections | ALB 200 mg Against T. Trichiura in PSAC | Cured | 2 | Participants | |
| Cure Rate Against T. Trichiura and Hookworm Infections | ALB 400 mg Against T. Trichiura in PSAC | Cured | 4 | Participants | |
| Cure Rate Against T. Trichiura and Hookworm Infections | ALB 600 mg Against T. Trichiura in PSAC | Cured | 5 | Participants | |
| Cure Rate Against T. Trichiura and Hookworm Infections | Placebo Against T. Trichiura in SAC | Cured | 3 | Participants | |
| Cure Rate Against T. Trichiura and Hookworm Infections | ALB 400 mg Against T. Trichiura in SAC | Cured | 7 | Participants | |
| Cure Rate Against T. Trichiura and Hookworm Infections | ALB 600 mg Against T. Trichiura in SAC | Cured | 11 | Participants | |
| Cure Rate Against T. Trichiura and Hookworm Infections | ALB 800 mg Against T. Trichiura in SAC | Cured | 7 | Participants | |
| Cure Rate Against T. Trichiura and Hookworm Infections | Placebo Against T. Trichiura in Adults | Cured | 1 | Participants | |
| Cure Rate Against T. Trichiura and Hookworm Infections | ALB 400 mg Against T. Trichiura in Adults | Cured | 5 | Participants |
1 to 10 of 135Source ClinicalTrials.gov
See all 135 results by groupParticipant flow78
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo Against T. Trichiura in PSAC | 27 | |
| Overall Study | STARTED | ALB 200 mg Against T. Trichiura in PSAC | 27 | |
| Overall Study | STARTED | ALB 400 mg Against T. Trichiura in PSAC | 30 | |
| Overall Study | STARTED | ALB 600 mg Against T. Trichiura in PSAC | 27 | |
| Overall Study | STARTED | Placebo Against T. Trichiura in SAC | 46 | |
| Overall Study | STARTED | ALB 400 mg Against T. Trichiura in SAC | 45 | |
| Overall Study | STARTED | ALB 600 mg Against T. Trichiura in SAC | 46 | |
| Overall Study | STARTED | ALB 800 mg Against T. Trichiura in SAC | 43 | |
| Overall Study | STARTED | Placebo Against T. Trichiura in Adults | 10 | |
| Overall Study | STARTED | ALB 400 mg Against T. Trichiura in Adults | 11 |
1 to 10 of 78Source ClinicalTrials.gov
See all 78 participant flowAdverse events182
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Headache | Nervous system disorders | Placebo Against T. Trichiura in PSAC | 1 | 27 | |
| other | Headache | Nervous system disorders | ALB 200 mg Against T. Trichiura in PSAC | 2 | 27 | |
| other | Headache | Nervous system disorders | ALB 400 mg Against T. Trichiura in PSAC | 3 | 30 | |
| other | Headache | Nervous system disorders | ALB 600 mg Against T. Trichiura in PSAC | 0 | 27 | |
| other | Headache | Nervous system disorders | Placebo Against T. Trichiura in SAC | 3 | 46 | |
| other | Headache | Nervous system disorders | ALB 400 mg Against T. Trichiura in SAC | 1 | 45 | |
| other | Headache | Nervous system disorders | ALB 600 mg Against T. Trichiura in SAC | 3 | 46 | |
| other | Headache | Nervous system disorders | ALB 800 mg Against T. Trichiura in SAC | 5 | 43 | |
| other | Headache | Nervous system disorders | Placebo Against T. Trichiura in Adults | 1 | 10 | |
| other | Headache | Nervous system disorders | ALB 400 mg Against T. Trichiura in Adults | 3 | 11 |
1 to 10 of 182Source ClinicalTrials.gov
See all 182 adverse eventsAdverse event totals78
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo Against T. Trichiura in PSAC | 0 | 27 |
| Total, all-cause mortality | ALB 200 mg Against T. Trichiura in PSAC | 0 | 27 |
| Total, all-cause mortality | ALB 400 mg Against T. Trichiura in PSAC | 0 | 30 |
| Total, all-cause mortality | ALB 600 mg Against T. Trichiura in PSAC | 0 | 27 |
| Total, all-cause mortality | Placebo Against T. Trichiura in SAC | 0 | 46 |
| Total, all-cause mortality | ALB 400 mg Against T. Trichiura in SAC | 0 | 45 |
| Total, all-cause mortality | ALB 600 mg Against T. Trichiura in SAC | 0 | 46 |
| Total, all-cause mortality | ALB 800 mg Against T. Trichiura in SAC | 0 | 43 |
| Total, all-cause mortality | Placebo Against T. Trichiura in Adults | 0 | 10 |
| Total, all-cause mortality | ALB 400 mg Against T. Trichiura in Adults | 0 | 11 |
1 to 10 of 78Source ClinicalTrials.gov
See all 78 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03527745
GET https://conductscience.org/api/trials/v1/NCT03527745/results?page=2