Clinical Trial: Phase 3 Study to Compare the Efficacy and Safety of AR01 to a Placebo Solution for Relief of Pain in Acute Otitis Media

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

Official Title: A Phase 3, Multicenter, Placebo-controlled, Double-blind, Randomized Study to Compare the Efficacy and Safety of AR01 Otic Solution to a Placebo Solution for Relief of Pain in Acute Otitis Media Subje

Brief Summary: Children ages 2 months to less than 19 years old, who have been diagnosed with a middle ear infection may receive either medicated ear drops (AR01) or glycerin (placebo) ear drops. The patient or caregiver will measure the amount of ear pain before and after the ear drops to establish if the medicated ear drops decrease the amount of pain more than the placebo ear drops. The subject may leave the clinic 60 minutes after the first dose. The ear drops can be used up to 4 days, as needed for ear pain.

Detailed Summary: The study involves the initial clinic visit, using the ear drops at home and keeping a diary about the ear pain experienced and medications taken. The patient will return to the clinic 4 days later for evaluation and to return the ear drops and diary. The clinic staff will call to follow-up about the patient's condition seven days after the initial visit.
Sponsor: Arbor Pharmaceuticals, Inc.

Current Primary Outcome: Complete ear pain relief [ Time Frame: At or prior to 60 minutes post baseline dose ]

The proportion of subjects with complete pain relief (score of 0 on Face, Activity, Ears, Cry, Consolability tool (FAECC) as measured by the Assigned Clinical Assessor or Faces Pain Scale-Revised (FPS-R) as measured by the subject prior to any analgesic/antipyretic use) at or prior to 60 minutes post baseline dose.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • time to complete pain relief (score of 0 on pain scales) [ Time Frame: 10, 20, 30, 45, and a60 minutes post baseline dose ]
    The time to complete pain relief (score of 0 on FAECC or FPS-R prior to any analgesic/antipyretic use), in minutes.
  • The proportion of subjects with complete ear pain relief [ Time Frame: at or prior to 10, 20, 30, 45, and 60 minutes post baseline dose ]
    The proportion of subjects with complete ear pain relief (score of 0 on FAECC or FPS-R prior to any analgesic/antipyretic use) at or prior to 10, 20, 30, 45, and 60 minutes post baseline dose.
  • The percent change in FPS-R and FAECC pain scores from baseline to post dose scores [ Time Frame: measured at 10, 20, 30, 45, and 60 minutes post baseline dose ]
  • Sum of pain intensity (SPID) using FPS-R and FAECC pain scores [ Time Frame: measured from baseline (pre-dose) to 60 minutes ]
  • Time from baseline to in-clinic use of analgesic/antipyretic to relief ear pain [ Time Frame: 60 Minutes ]
  • The number of subjects who receive analgesic/antipyretic medications for relief of ear pain during the clinic visit [ Time Frame: measured at or prior to 10, 20, 30, 45, and 60 minutes post baseline dose ]
  • Number of adverse events reported as a measure of safety and tolerability [ Time Frame: up to 30 days ]
    measured by treatment-emergent adverse events (AEs), concomitant medications, vital signs (pulse, temperature, and respiratory rate), abbreviated physical examination (head, ears, eyes, nose and throat and chest), external ear canal and pinna for signs of local tissue toxicity, such as rash, urticaria, local burning or stinging, skin discoloration, swelling, itching, and severe redness, and an assessment for signs of methemoglobinemia (i.e., unexplained bluish coloring of skin, fatigue, shortness of breath, failure to thrive, and headache).


Original Secondary Outcome: Same as current

Information By: Arbor Pharmaceuticals, Inc.

Dates:
Date Received: January 22, 2014
Date Started: December 2013
Date Completion:
Last Updated: March 19, 2015
Last Verified: March 2015