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Pharmacokinetic Study of AL-60371 Otic Suspension in Pediatric Subjects Following Tympanostomy Tube Surgery

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ClinicalTrials.gov Identifier: NCT01908764
Recruitment Status : Withdrawn (Management Decision)
First Posted : July 26, 2013
Last Update Posted : March 8, 2016
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Brief Summary:
The purpose of this study is to describe the pharmacokinetics of AL-60371 otic suspension following two posologies of bilateral ototopical doses in pediatric subjects immediately after bilateral tympanostomy tube surgery.

Condition or disease Intervention/treatment Phase
Otitis Media Drug: AL-60371 otic suspension Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: An Open-Label, Single Dose, Pharmacokinetic Study of AL-60371 Otic Suspension, 0.3% in Pediatric Subjects Following Tympanostomy Tube Surgery
Study Start Date : November 2014
Estimated Primary Completion Date : January 2015
Estimated Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ear Infections
U.S. FDA Resources

Arm Intervention/treatment
Experimental: AL-60371/Posology 1
AL-60371 otic suspension, single dose of 200 µL following surgical insertion of tympanostomy tubes
Drug: AL-60371 otic suspension
Experimental: AL-60371/Posology 2
AL-60371 otic suspension, single dose of 4 drops following surgical insertion of tympanostomy tubes
Drug: AL-60371 otic suspension



Primary Outcome Measures :
  1. Maximum observed analyte plasma concentration (Cmax) [ Time Frame: 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).

  2. Time to reach Cmax (Tmax) [ Time Frame: 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).

  3. Area under the analyte plasma concentration-time curve to the last quantifiable sampling time point (AUC0-last) [ Time Frame: 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).

  4. Area under the concentration-time curve from 0 to infinity (AUC0-∞) [ Time Frame: 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).

  5. Time to last measurable concentration (Tlast) [ Time Frame: 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).

  6. The terminal elimination half (T½) [ Time Frame: 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).



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Ages Eligible for Study:   6 Months to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Requires bilateral myringotomy and tympanostomy tube insertion;
  • Provides informed consent (parent/legal guardian);
  • Signs assent form where applicable (subject);
  • Accompanied by parent/legal guardian at each visit;
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Menarcheal females;
  • Current or recent history of any disease which, in the opinion of the Principal Investigator, may place the subject at risk or interfere with study;
  • Use of excluded medications within one week prior to surgery and for the duration of the study;
  • Requires another surgical procedure in addition to the myringotomy;
  • Clinically relevant otic condition which, in the opinion of the Principal Investigator, would preclude the safe administration of the study medication;
  • Participation in any other investigational study within 30 days before entry into this study or along with this study;
  • Known or suspected allergy or hypersensitivity to any active or inactive ingredient in the test article;
  • Other protocol-defined exclusion criteria may apply.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01908764


Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Celeste McClean, BS, MT (ASCP) Alcon Research

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01908764     History of Changes
Other Study ID Numbers: C-13-023
First Posted: July 26, 2013    Key Record Dates
Last Update Posted: March 8, 2016
Last Verified: October 2014

Keywords provided by Alcon Research:
ear tubes
tympanostomy tubes
Otitis Media at the time of Tympanostomy Tube surgery
OMTT

Additional relevant MeSH terms:
Otitis
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases