A Phase 3 interventional study of FST-201 (dexamethasone 0.1%) Otic Suspension and ciprofloxacin 0.3%, dexamethasone 0.1% in Acute Otitis Externa, sponsored by Shire. Terminated at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-27.
Sponsored by Shire (part of Takeda) · Phase 3, Interventional, and Treatment
The objective of this study is to evaluate the efficacy of FST-201 compared to Ciprodex in the treatment of acute otitis externa. This trial is designed to enable filing of a New Drug Application in support of FST-201 for the indication of acute otitis externa.
22 studies on the registry are indexed under Otitis Externa; 1 is open to participants now.
This study's enrollment of 5 is below the median of 100 across 20 interventional studies indexed under Otitis Externa.
Browse Otitis Externa studies →Shire is the lead sponsor of 351 studies on the registry; 2 are open to participants now.
Of its 48 completed or terminated interventional studies of FDA-regulated products, 48 (100%) have results posted.
First submitted before Shire became part of Takeda.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
All subjects must not:
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Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: FST-201 (dexamethasone 0.1%) Otic Suspension
Drug: ciprofloxacin 0.3%, dexamethasone 0.1%
Instill four drops two times a day
Instill four drops two times a day
Also known as: Ciprodex
Overall clinical cure as defined by absence of the signs and symptoms of AOE including ear inflammation, edema, tenderness and otic discharge.
Time frame: 1 year
Microbiological resolution defined as elimination of pre-treatment pathogenic bacteria.
Time frame: 1 year
Ran from Jul 2009 to primary completion in Jul 2010, 12 months.
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This study is terminated, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dexamethasone