Clinical Trial: Study of FAECC Scale (Modified FLACC) to Evaluate Ear Pain in Children With Acute Otitis Media

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Phase 2, Multicenter, Placebo-controlled, Double-masked, Randomized Study to Demonstrate Reliability and Validity of FAECC Scale (Modified FLACC) to Evaluate Relief of Pain in Subjects With Acute Otit

Brief Summary: This study is to assess the reliability and validity of the FAECC scale to evaluate pain associated with acute otitis media in children aged 2 months to 5 years.

Detailed Summary: to assess the reliability and validity of the FAECC pain scale tool in children aged 2 months to 5 years with acute otitis media given AR01 or placebo
Sponsor: Arbor Pharmaceuticals, Inc.

Current Primary Outcome: Consistency of primary assessor and caregiver FAECC scores using Pearson's correlation coefficient [ Time Frame: up to 120 minutes after first dose and Day 4 ]

Original Primary Outcome: Same as current

Current Secondary Outcome: reduction in pain scores from predose to each post-dose time point [ Time Frame: up to 120 minutes after each dose ]

Original Secondary Outcome: Same as current

Information By: Arbor Pharmaceuticals, Inc.

Dates:
Date Received: April 27, 2012
Date Started: May 2012
Date Completion:
Last Updated: April 13, 2015
Last Verified: March 2015