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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 is a Phase 3 study that has completed, run by Arbor Pharmaceuticals. The registered enrollment target is 304 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02044341
The ClinicalTrials.gov registry entry for NCT02044341 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 304 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Arbor Pharmaceuticals, which has 14 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which AR01 is the first listed.
NCT02044341 reports 0 study locations.
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.
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