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NCT02074007 · ClinicalTrials.gov registry record · Phase 3
Study to Compare Efficacy and Safety of AR01 to a Placebo Solution for Relief of Pain in Acute Otitis Media (AR01007)
A Phase 3 study, sponsored by Arbor Pharmaceuticals.
- Terminated
- Registry status
- Phase 3
- Development phase
- 178
- Enrollment target
NCT02074007 is a Phase 3 study that was terminated before completion, run by Arbor Pharmaceuticals. The registered enrollment target is 178 participants.
The verdict
NCT02074007, a Phase 3 study, was terminated before completion, sponsored by Arbor Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 178 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 Placebo Comparator
- DRUG AR01
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 178 participants |
| Start Date | 2013-12 |
| Est. Completion | 2014-06 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02074007
The ClinicalTrials.gov registry entry for NCT02074007 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 178 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 Placebo Comparator is the first listed.
NCT02074007 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02074007 about?
NCT02074007 is a clinical study titled "Study to Compare Efficacy and Safety of AR01 to a Placebo Solution for Relief of Pain in Acute Otitis Media (AR01007)". 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 NCT02074007?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 178 participants. The study started on 2013-12. Estimated completion is 2014-06.
What interventions are being tested in trial NCT02074007?
The interventions under investigation include: Placebo Comparator (DRUG), AR01 (DRUG).
Who is sponsoring clinical trial NCT02074007?
This trial is sponsored by Arbor Pharmaceuticals, which has 14 total clinical trials registered on ClinicalTrials.gov.
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