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NCT02044341 · ClinicalTrials.gov registry record · Phase 3
Phase 3 Study to Compare the Efficacy and Safety of AR01 to a Placebo Solution for Relief of Pain in Acute Otitis Media
A Phase 3 study, sponsored by Arbor Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 304
- Enrollment target
NCT02044341: Completed Phase 3 study, sponsored by Arbor Pharmaceuticals.
NCT02044341 is a Phase 3 study that has completed, run by Arbor Pharmaceuticals. The registered enrollment target is 304 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (61% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02044341, a Phase 3 study, has completed, sponsored by Arbor Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 304 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG AR01
- DRUG Glycerin ear drops
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 304 participants |
| Start Date | 2013-12 |
| Est. Completion | 2014-03 |
| Phase | Phase 3 |
What the finished NCT02044341 record still lists
NCT02044341 is an interventional study that assigns participants to a tested intervention. The registered 304 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (61% lower).
The record links to 0 conditions, and to 2 interventions - of which AR01 is the first listed.
NCT02044341 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02044341 about?
NCT02044341 is a clinical study titled "Phase 3 Study to Compare the Efficacy and Safety of AR01 to a Placebo Solution for Relief of Pain in Acute Otitis Media". 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 medicat...
What is the current status of trial NCT02044341?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 304 participants. The study started on 2013-12. Estimated completion is 2014-03.
What interventions are being tested in trial NCT02044341?
The interventions under investigation include: AR01 (DRUG), Glycerin ear drops (DRUG).
Who is sponsoring clinical trial NCT02044341?
This trial is sponsored by Arbor Pharmaceuticals, which has 14 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02044341's enrollment target sits among peer trials
304 1117th of 2000 higher than 882 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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