Trial · NCT01083576
Outcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Who Obtained Final Clinical Cure of Index Lesion | 168 days | All randomized subjects were included in the mITT Analysis. All subjects met criteria for the evaluable subset. | Participants | NUMBER |
| SECONDARY | Number of Participants Who Obtained a Modified Final Clinical Cure of All Lesions | 168 days | All randomized subjects were included in the mITT Analysis. All subjects met criteria for the evaluable subset. | Participants | NUMBER |
| SECONDARY | Detectable Paromomycin or Gentamicin Plasma Levels | 20 days | Adults ages \>= 17 years | Participants | NUMBER |
| SECONDARY | Paromomycin Plasma Concentrations in Adults | Day 4 to Day 28 | Adults ages \>= 17 years | ng/mL | MEAN |
| SECONDARY | Paromomycin Plasma Concentrations in Children | Days 1 and 20 | Children ages 7 to 16 | ng/mL | MEAN |
| SECONDARY | Pharmacokinetic Parameter: Cmax | 0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20 | Adults with measurable samples. | ng/mL | MEAN |
| SECONDARY | Pharmacokinetic Parameter: Tmax | 0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20 | Adults ages \>= 17 years with measurable samples. Both groups had only 6 measureable samples each on Day 1. | hr | MEAN |
| SECONDARY | Pharmacokinetic Parameter: Area Under the Curve (AUC) | 0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20 | Adults ages \>= 17 years with measurable samples. | ng*hr/mL | MEAN |
| OTHER_PRE_SPECIFIED | Serum Creatinine Levels | Day 1 and Day 20 | All randomized subjects were included in the mITT Analysis. All subjects met criteria for the evaluable subset. | mg/dL | MEAN |
| SECONDARY | Pharmacokinetic Parameter: t(1/2) | 0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20 | Adults ages \>= 17 years with measurable samples. Paromomycin Alone Treatment had only 5 measureable samples on Day 1, and WR 279,396 had only 4 measureable samples on Day 20. | hr | MEAN |
| SECONDARY | Pharmacokinetic Parameter: Cmax/D | 0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20 | Adults ages \>= 17 years with measurable samples. | 1/ML | MEAN |
| SECONDARY | Pharmacokinetic Parameter: AUC/D | Days 1 and 20 | Adults ages \>= 17 years with measurable samples. | hr/ML | MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT01083576/outcomes