Trial · NCT01908764
Pharmacokinetic Study of AL-60371 Otic Suspension in Pediatric Subjects Following Tympanostomy Tube Surgery
NCT01908764, Phase 1, Withdrawn, Alcon Research
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pharmacokinetic Study of AL-60371 Otic Suspension in Pediatric Subjects Following Tympanostomy Tube Surgery. Trials, record NCT01908764. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01908764
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pharmacokinetic Study of AL-60371 Otic Suspension in Pediatric Subjects Following Tympanostomy Tube Surgery
- NCT number
- NCT01908764
- Status
- Withdrawn
- Phases
- Phase 1
- Enrollment
- 0 participants, actual
- Lead sponsor
- Alcon Research
- Conditions
- Otitis Media
- Interventions
- AL-60371 otic suspension
- First posted
- 2013-07-26
- Last updated
- 2016-03-08
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum observed analyte plasma concentration (Cmax) | Day 1/Surgery Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6 hours post-dose | The analyte plasma concentrations at each collection time point will be quantitated using a high performance liquid chromatography/tandem mass spectrometry method (HPLC/MS/MS). |
| Primary | Time to reach Cmax (Tmax) | Day 1/Surgery Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6 hours post-dose | The analyte plasma concentrations at each collection time point will be quantitated using a high performance liquid chromatography/tandem mass spectrometry method (HPLC/MS/MS). |
| Primary | Area under the analyte plasma concentration-time curve to the last quantifiable sampling time point (AUC0-last) | Day 1/Surgery Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6 hours post-dose | The analyte plasma concentrations at each collection time point will be quantitated using a high performance liquid chromatography/tandem mass spectrometry method (HPLC/MS/MS). |
| Primary | Area under the concentration-time curve from 0 to infinity (AUC0-∞) | Day 1/Surgery Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6 hours post-dose | The analyte plasma concentrations at each collection time point will be quantitated using a high performance liquid chromatography/tandem mass spectrometry method (HPLC/MS/MS). |
| Primary | Time to last measurable concentration (Tlast) | Day 1/Surgery Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6 hours post-dose | The analyte plasma concentrations at each collection time point will be quantitated using a high performance liquid chromatography/tandem mass spectrometry method (HPLC/MS/MS). |
| Primary | The terminal elimination half (T½) | Day 1/Surgery Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6 hours post-dose | The analyte plasma concentrations at each collection time point will be quantitated using a high performance liquid chromatography/tandem mass spectrometry method (HPLC/MS/MS). |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01908764
GET https://conductscience.org/api/trials/v1/NCT01908764/registered