Proof-of-Concept Study of a Single Application of an Investigational Otic Suspension in Treatment… (NCT01908803) | Clinical Trial Compass
TerminatedPhase 2
Proof-of-Concept Study of a Single Application of an Investigational Otic Suspension in Treatment of Acute Otitis Media With Tympanostomy Tubes
Stopped: Management decision
84 participantsStarted 2013-12
Plain-language summary
The purpose of this study is to evaluate a single application of AL-60371/AL-817 Otic Suspension relative to ototopical CIPRODEX for sustained clinical cure, microbiological success, and time to cessation of otorrhea.
Who can participate
Age range6 Months – 12 Years
SexALL
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Inclusion Criteria:
* Parent or guardian: Read and sign the informed consent. When required by the Institutional Review Board, child must agree to sign an approved assent form;
* Presence of otorrhea (visible by parent or guardian) of 21 days or less in duration;
* Presence of patent tympanostomy tubes;
* Refrain from water immersion of the ears following surgery without the use of adequate ear protection during swimming, bathing, showering and other water-related activities;
* Parent or guardian: Agree to comply with the requirements of the study, administer the study medication as directed, complete required study visits, and comply with the protocol;
* Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
* NOT otorrhea-free for at least seven days following tympanostomy tube surgery;
* Menarcheal females;
* Previous otologic surgery, except tympanic membrane, within one year of study entry;
* History of/or current acute or chronic non-tube otorrhea (through existing perforation of the eardrum);
* Current acute otitis externa, malignant otitis externa, or other conditions which could interfere with evaluation of the study drug;
* Diabetic (controlled or uncontrolled);
* Use of prohibited medications;
* Other protocol-defined exclusion criteria may apply.
What they're measuring
1
Proportion of Subjects With Sustained Clinical Cure at Day 3 Visit
Timeframe: Day 3 post-treatment up to Day 8 or Early Exit