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

NCT ID: NCT01908764

Last Updated: 2016-03-08

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2015-01-31

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.

Conditions

Otitis Media

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

AL-60371/Posology 1

AL-60371 otic suspension, single dose of 200 µL following surgical insertion of tympanostomy tubes

Group Type: EXPERIMENTAL

AL-60371 otic suspension

Intervention Type: DRUG

AL-60371/Posology 2

AL-60371 otic suspension, single dose of 4 drops following surgical insertion of tympanostomy tubes

Group Type: EXPERIMENTAL

AL-60371 otic suspension

Intervention Type: DRUG

Interventions

AL-60371 otic suspension

Intervention Type: DRUG

Eligibility 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;

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;

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Celeste McClean, BS, MT (ASCP)

Role: STUDY_DIRECTOR

Alcon Research

Other Identifiers

C-13-023

Identifier Type: -

Identifier Source: org_study_id