Trial · NCT01083576
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Who Obtained Final Clinical Cure of Index Lesion | 168 days | Number of participants who had initial clinical cure (100% re-epithelialization of index lesion by Day 63) OR initial clinical improvements (\> 50% re-epithelialization of index lesion followed by Day 63 by 100% re-epithelialization of the index lesion on or before Day 100), AND no relapse of index lesion. |
| Secondary | Number of Participants Who Obtained a Modified Final Clinical Cure of All Lesions | 168 days | Final cure as defined by the primary outcome measure AND and cure of all other lesions by Day 168. (100% re-epithelialization of all ulcerated lesions and resolution of all other type of lesions) |
| Secondary | Detectable Paromomycin or Gentamicin Plasma Levels | 20 days | Proportion of subjects with any detectable Paromomycin or Gentamicin plasma levels on a study day when blood for PK was collected |
| Secondary | Paromomycin Plasma Concentrations in Adults | Day 4 to Day 28 | Paromomycin plasma concentrations following administration of paromomycin alone or WR 279,396 in adults |
| Secondary | Paromomycin Plasma Concentrations in Children | Days 1 and 20 | Paromomycin plasma concentrations 4 hours following administration of paromomycin alone or WR 279,396 in children |
| 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 | Cmax of paromomycin following administration of paromomycin alone or WR 279,396 to adults in Panama |
| 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 | Tmax of paromomycin following administration of paromomycin alone or WR 279,396 to adults in Panama |
| 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 | Area under the curve (AUC) of paromomycin following administration of paromomycin alone or WR 279,396 to adults in Panama |
| 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 | t(1/2) of paromomycin following administration of paromomycin alone or WR 279,396 to adults in Panama |
| 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 | Maximum observed plasma concentration divide by topical dose (Cmax/D) of paromomycin following administration of paromomycin alone or WR 279,396 to adults in Panama |
| Secondary | Pharmacokinetic Parameter: AUC/D | Days 1 and 20 | Area under the plasma concentration-time curve over 24 hrs divided by topical dose (AUC/D) of paromomycin following administration of paromomycin alone or WR 279,396 to adults in Panama |
| Other | Serum Creatinine Levels | Day 1 and Day 20 | Blood creatinine was measured to assess possible nephrotoxicity associated with aminoglycosides |
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.
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