Phase III Study Evaluating Topical Benzocaine for Treatment of Acute Otitis Media in Children
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|ClinicalTrials.gov Identifier: NCT03116737|
Recruitment Status : Completed
First Posted : April 17, 2017
Last Update Posted : October 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Pain Acute Otitis Media||Drug: Benzocaine Otic Solution Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||141 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Phase III, Multicenter, Randomized, Double-Blind, Placebo- Controlled Parallel-Designed Evaluation to Assess Safety and Efficacy of Topical Benzocaine for Treatment of Pain Associated With Acute Otitis Media in Children Ages 5 to 12 Years|
|Actual Study Start Date :||January 3, 2017|
|Actual Primary Completion Date :||July 21, 2017|
|Actual Study Completion Date :||July 21, 2017|
|Experimental: Benzocaine Otic Solution||
Drug: Benzocaine Otic Solution
|Placebo Comparator: Placebo||
Other Name: Topical otic solution
- Summed Pain Intensity Difference Assessed by Faces Pain Scale-Revised (FPS-R) [ Time Frame: 60 minutes ]
- Summed Pain Intensity Difference Assessed by Faces Pain Scale-Revised (FPS-R) [ Time Frame: 120 minutes ]
- Pain Intensity Difference Assessed by Faces Pain Scale-Revised (FPS-R) [ Time Frame: Up to 3 days ]
- Dosing Intervals [ Time Frame: Up to 3 days ]
- Use of Rescue Medications [ Time Frame: Up to 3 days ]
- Assess the Safety and Tolerability of Benzocaine Based on Reported Adverse Events [ Time Frame: Up to 3 days ]Safety will be assessed by adverse event reporting on all study days. Fisher's exact test will be used to compare adverse event rates between treatment groups for the following categories: 1) all adverse events; 2) treatment related adverse events; 3) severe adverse events; 4) serious adverse events; 5) discontinuation due to adverse event.
- Assess the Safety and Tolerability of Benzocaine Based on Physical Examinations [ Time Frame: Up to 3 days ]Physical examinations will be assessed. For each body system of the physical examination, the shift from normal/abnormal will be presented by treatment group as the number and percentage of children.
- Assess the Safety and Tolerability of Benzocaine Based on Vital Signs [ Time Frame: Up to 3 days ]Vital signs (blood pressure, pulse, temperature, and respiratory rate) will be assessed. Descriptive statistics will be presented for the vital signs measurements collected, as well as the vital sign changes from Day 1 to Day 3 by treatment group.
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): NCT03116737
|United States, Oregon|
|Gresham, Oregon, United States, 89104|