Trial · NCT02630992
Outcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Distribution of Participants Receiving Formulation 1 for Whom Protocol-Defined Diarrhea (PDD) Was Reported and Associated With Study Product | Day 1 of administration of amoxicillin-clavulanate until day 12. | The number of participants is equal to the number of children receiving formulation 1. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | The Distribution of Participants Receiving Formulation 2 for Whom Protocol-Defined Diarrhea (PDD) Was Reported and Associated With Study Product | Day 1 of administration of amoxicillin-clavulanate until day 12. | The number of participants is equal to the number of children receiving formulation 2. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | The Distribution of Participants Receiving Formulation 1 for Whom Diaper Dermatitis Was Reported and Associated With Study Product | Day 1 of administration of amoxicillin-clavulanate until day 12. | The number of participants is equal to the number of children receiving formulation 1. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | The Distribution of Participants Receiving Formulation 2 for Whom Diaper Dermatitis Was Reported and Associated With Study Product | Day 1 of administration of amoxicillin-clavulanate until day 12. | The number of participants is equal to the number of children receiving formulation 2. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | The Distribution of Participants Receiving Formulation 1 Categorized as Treatment Failure (TF) at or Before the End-of-Treatment Visit | From 72 hours after the initial AOM until the end-of-treatment visit. The mean day for this visit was 14.9. | The number of participants is equal to the number of children receiving formulation 1 who had an end-of-treatment assessment at or before the day 12 visit. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | The Distribution of Participants Receiving Formulation 2 Categorized as Treatment Failure (TF) at or Before the End-of-Treatment Visit | From 72 hours after the initial AOM until the end-of-treatment visit. The mean day for this visit was 13.9. | The number of participants is equal to the number of children receiving formulation 2 who had an end-of-treatment assessment at or before the day 12 visit. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | The Distribution of Participants Receiving Formulation 1 Demonstrating Resolution of Acute Otitis Media (AOM) and Substantial Improvement of Symptoms That Would Allow Discontinuing Therapy at the Day 7 Visit | Day 1 of administration of amoxicillin-clavulanate until the day 7 visit. The mean day for this visit was 7.5. | The number of participants is equal to the number of children receiving formulation 1 who had a day 7 assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | The Distribution of Participants Receiving Formulation 2 Demonstrating Resolution of Acute Otitis Media (AOM) and Substantial Improvement of Symptoms That Would Allow Discontinuing Therapy at the Day 7 Visit | Day 1 of administration of amoxicillin-clavulanate until the day 7 visit. The mean day for this visit was 7.6. | The number of participants is equal to the number of children receiving formulation 2 who had a day 7 assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | The Mean Score Representing the Parent or Guardian's Level of Satisfaction With Therapy for Participants Receiving Formulation 1 | The end-of-treatment visit. The mean day for this visit was 14.9. | The number of participants is equal to the number of children receiving formulation 1 whose parent or guardian completed a level of satisfaction questionnaire at the end-of-treatment visit. | units on a scale | MEAN |
| SECONDARY | The Mean Score Representing the Parent or Guardian's Level of Satisfaction With Therapy for Participants Receiving Formulation 2 | The end-of-treatment visit. The mean day for this visit was 13.9. | The number of participants is equal to the number of children receiving formulation 2 whose parent or guardian completed a level of satisfaction questionnaire at the end-of-treatment visit. | units on a scale | MEAN |
| SECONDARY | Distribution of Population Plasma Concentration of Amoxicillin According to Time For Participants Receiving Formulation 1 | From administration of a single dose of amoxicillin-clavulanate until approximately 4 hours after. | The participants are the children receiving formulation 1 whose parent or guardian agreed to a single blood draw after administration of a single dose of amoxicillin-clavulanate and who had an ensuing measure of plasma concentration. | micrograms per milliliter (mcg/ml) | MEAN |
| SECONDARY | Distribution of Population Plasma Concentration of Amoxicillin According to Time For Participants Receiving Formulation 2 | From administration of a single dose of amoxicillin-clavulanate until approximately 4 hours after. | The participants are the children receiving formulation 2 whose parent or guardian agreed to a single blood draw after administration of a single dose of amoxicillin-clavulanate and who had an ensuing measure of plasma concentration. | micrograms per milliliter (mcg/ml) | MEAN |
| SECONDARY | Distribution of Population Plasma Concentration of Clavulanate According to Time For Participants Receiving Formulation 1 | From administration of a single dose of amoxicillin-clavulanate until approximately 4 hours after. | The participants are the children receiving formulation 1 whose parent or guardian agreed to a single blood draw after administration of a single dose of amoxicillin-clavulanate and who had an ensuing measure of plasma concentration. | nanograms per milliliter (ng/ml) | MEAN |
| SECONDARY | Distribution of Population Plasma Concentration of Clavulanate According to Time For Participants Receiving Formulation 2 | From administration of a single dose of amoxicillin-clavulanate until approximately 4 hours after. | The participants are the children receiving formulation 2 whose parent or guardian agreed to a single blood draw after administration of a single dose of amoxicillin-clavulanate and who had an ensuing measure of plasma concentration. | nanograms per milliliter (ng/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.
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GET https://conductscience.org/api/trials/v1/NCT02630992/outcomes