Trial · NCT01032382
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Final Clinical Cure for Index Lesions | Initial clinical cure by day 63 and no relapse by day 168 | Final clinical cure was defined as follows: 1. Subject has initial clinical cure (100% re-epithelialization of index lesion by nominal Day 63); OR, 2. Subject has initial clinical improvement (\> 50% re-epithelialization of index lesion by nominal Day 63 followed by 100% re-epithelialization of the index lesion on or before nominal Day 100; AND, 3. Subject has no relapse of index lesion by Day 168. Relapse was defined as an index lesion meeting the criteria for initial clinical cure that had any new ulceration/nodule (\> 0 x 0 mm measurement) by nominal day 168, or an index lesion meeting the criteria for initial clinical improvement that subsequently enlarged by nominal Day 168. |
| Secondary | Detectable Paromomycin Plasma Levels | Day 4, 7, 12, 17, 20, 28 | Paromomycin plasma concentrations following administration of paromomycin alone or WR 279,396 in adults |
| Secondary | Paromomycin Plasma Concentrations in Children | 0 and 4 hours on 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 | Pharmacokinetic Parameter: Tmax |
| 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 |
| Secondary | Final Clinical Cure on All Lesions Independent of Subjects | Initial clinical cure by day 63 and no relapse by day 168 | Final clinical cure was defined as follows: 1. Subject has initial clinical cure (100% re-epithelialization of lesion by nominal Day 63); OR, 2. Subject has initial clinical improvement (\> 50% re-epithelialization of lesion by nominal Day 63 followed by 100% re-epithelialization of the lesion on or before nominal Day 100; AND, 3. Subject has no relapse of lesion by Day 168. Relapse was defined as a lesion meeting the criteria for initial clinical cure that had any new ulceration/nodule (\> 0 x 0 mm measurement) by nominal day 168, or a lesion meeting the criteria for initial clinical improvement that subsequently enlarged by nominal Day 168. |
| Secondary | Number of Index Lesions Meeting Criteria for Clinical Cure During the Study | Day 1, 4, 7, 12, 17, 20, 28, 35, 42, 49, 56, 63, 100, 168 | Number of study participants who meet the criteria for clinical cure (100% re-epithelialization) at specified timepoints during the study. |
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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