Phase 1
N=14
Pediatric Pharmacokinetic (PK) Study of EXE844 Otic Suspension in Otitis Media at the Time of Tympanostomy Tube Insertion (OMTT)
Otitis Media With Effusion in Children · Otitis Media Recurrent
Bottom Line
View on ClinicalTrials.gov: NCT02539654 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Jul 2018
Primary outcome: Primary: Maximum Analyte Plasma Concentration (Cmax) — 2.44; 1.61 ng/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- EXE844 Sterile Otic Suspension, 0.3% (Drug); Tympanostomy Tube Insertion (Procedure)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Analyte Plasma Concentration (Cmax) |
2.44; 1.61 | — |
| PRIMARY Time to Reach Maximum Concentration (Tmax) |
0.59; 1.00 | — |
| PRIMARY Area Under the Plasma Concentration-time Curve to the Last Quantifiable Sampling Time Point (AUC0-last) |
8.66; 3.94 | — |
| PRIMARY Area Under the Concentration-time Curve From 0 to Infinity (AUC0-inf) |
10.60; 19.90 | — |
| PRIMARY Time to Last Measurable Concentration (Tlast) |
5.90; 2.17 | — |
| PRIMARY Terminal Elimination Half-life (T1/2) |
2.05; 4.42 | — |
Summary
The purpose of this study is to describe the pharmacokinetics (PK) of EXE844 Sterile Otic Suspension, 0.3% following a single bilateral ototopical dose in pediatric subjects, immediately after bilateral tympanostomy tube surgery.
Eligibility Criteria
Inclusion Criteria
- Recurrent acute otitis media (RAOM) or chronic otitis media with effusion (COME) and eligible for bilateral myringotomy and tympanostomy tube insertion;
- Legally Authorized Representative (LAR) must read and sign the informed consent;
- Parent or caregiver must agree to complete the required study visits and comply with the requirements of the study;
- Other protocol-specified inclusion criteria may apply.
Exclusion Criteria
- Menarcheal females;
- Previous otologic or otologic-related surgery within the past 30 days or ongoing complications;
- Existing perforation of the eardrum;
- Current acute otitis externa (AOE), malignant otitis externa (MOE) or other conditions which could interfere with evaluation of the study drug;
- Any systemic disease or disorder, complicating factor or structural abnormality that would negatively affect the conduct or outcome of the study;
- Use of prohibited medications or inadequate washout of any medication including systemic and topical antibiotics, steroids and/or analgesics;
- Weighs less than 8 kg;
- Other protocol-specified exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02539654). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.