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Trial · NCT02817347

Registered outcomes14

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryThe proportion of patients achieving cessation of otorrhea on Day 15.Day 15The proportion of patients achieving cessation of otorrhea (grade 0) on Day 15, as evidenced by otoscopy
SecondaryThe proportion of patients with cessation of otorrhea on Day 8.Day 8The proportion of patients with cessation of otorrhea on Day 8 as evidenced by otoscopy.
SecondaryThe proportion of patients with cessation of otorrhea on Day 22.Day 22The proportion of patients with cessation of otorrhea on Day 22 as evidenced by otoscopy.
SecondaryProportion of patients with improved otorrhea at each visit, as evidenced by otoscopyDay 8'improved otorrhea' is defined as at least one level decrease from baseline in the otorrhea severity grading scale
SecondaryProportion of patients with improved otorrhea at each visit, as evidenced by otoscopyDay 15'improved otorrhea' is defined as at least one level decrease from baseline in the otorrhea severity grading scale
SecondaryProportion of patients with improved otorrhea at each visit, as evidenced by otoscopyDay 22'improved otorrhea' is defined as at least one level decrease from baseline in the otorrhea severity grading scale
SecondaryMicrobiological eradicationDay 8, 15, 22Proportion of patients with microbiological eradicationat each visit
OtherCmaxpre-dose, and at 0.25, 0.5, 1, 2, 4 and 6 hoursMaximum plasma concentration
OtherAUClastpre-dose, and at 0.25, 0.5, 1, 2, 4 and 6 hoursThe area under the plasma concentration-time curve from time zero until the last measurable concentration
OtherAUCinfpre-dose, and at 0.25, 0.5, 1, 2, 4 and 6 hoursThe area under the plasma concentration - time curve from time zero to infinite time
OtherTmaxpre-dose, and at 0.25, 0.5, 1, 2, 4 and 6 hoursTime to reach Cmax
Othert1/2pre-dose, and at 0.25, 0.5, 1, 2, 4 and 6 hoursTerminal elimination half-life
OtherCL/Fpre-dose, and at 0.25, 0.5, 1, 2, 4 and 6 hoursApparent plasma clearance
OtherVd/Fpre-dose, and at 0.25, 0.5, 1, 2, 4 and 6 hoursApparent volume of distribution

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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