Acute Otitis Externa Clinical Trial
Official title:
A Randomised, Parallel-group, Double-blind, Placebo-controlled Study of DPK-060 to Investigate Clinical Safety and Efficacy in Patients With Acute External Otitis
Verified date | October 2013 |
Source | DermaGen AB |
Contact | n/a |
Is FDA regulated | No |
Health authority | Sweden: Medical Products Agency |
Study type | Interventional |
The primary objective of this study is to evaluate safety and tolerability of DPK-060 2% ear drops compared to placebo for DPK-060 ear drops in patients with acute external otitis. The secondary objectives are to evaluate clinical cure and microbiological growth following treatment with DPK-060 2% ear drops compared to placebo for DPK-060 ear drops.
Status | Completed |
Enrollment | 69 |
Est. completion date | November 2012 |
Est. primary completion date | October 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 12 Years and older |
Eligibility |
Inclusion Criteria: - A clinical diagnosis of acute external otitis of a severity degree not requiring specialist care - Age 12 years and older Exclusion Criteria: - Known or suspected perforation of the tympanic membrane - A clinical diagnosis of chronic suppurative otitis media, acute otitis media, acute otorrhea or malignant otitis externa - Local ear canal abnormalities - Congenital abnormalities of the external auditory canal or obstructive bony exostosis - Mastoiditis or suppurative non-infectious ear disorders (e.g. cholesteatoma) - Malignant tumour of the external auditory canal - History of otologic surgery (except for surgery confined to the temporomandibular joint) - Seborrheic dermatitis or other dermatological conditions of the external auditory canal that would complicate evaluation - Current or prior use (within 7 days) of ear washes using alcohol, vinegar or other astringents - Any clinically relevant past or present infectious/viral disease - Current infection requiring systemic antimicrobial therapy - Current or prior use of systemic (within 14 days) or topical (within 7 days) antibiotics - Current or prior use of systemic (within 30 days) or topical (within 7 days) steroids - History of immune dysfunction/deficiency and immunosuppressive therapy - Diabetes mellitus |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Sweden | Hagakliniken | Gothenburg | |
Sweden | Me3+ Clinical Trials | Gothenburg | |
Sweden | Hallands Sjukhus | Halmstad | |
Sweden | ProbarE | Lund | |
Sweden | Curakliniken | Malmö | |
Sweden | S3 Clinical Research Center, Vällingby | Stockholm | |
Sweden | Värmdö vårdcentral | Stockholm |
Lead Sponsor | Collaborator |
---|---|
DermaGen AB | Pergamum AB |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adverse Events (AEs) | AEs were collected by a non-leading question such as "have you experienced any new health problems or worsening of existing conditions" as well as reporting events directly observed or spontaneously volunteered by patients. All AEs including but not limited to events reported by the patient, or reported in answer to an open question by the Investigator or member of the study team were recorded as an AE including the following information: Diagnosis; Start date (and time, if relevant), Stop date (and time, if relevant) or resolution; Severity; Action taken; Causality; Seriousness; Outcome. | AEs occurring during the treatment period were collected on day 8 or 11, as applicable. Four weeks after the last dose of investigational medicinal product (IMP), previously reported AEs were followed up and assessed as "recovered" or "not recovered". | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02918773 -
Pediatric Emergency Department Smartphone Otoscope Study (PED-Oto)
|
N/A | |
Not yet recruiting |
NCT04636957 -
A Phase III Study of Ciprofloxacin Plus Fluocinolone in Acute Otitis Externa (AOE)
|
Phase 3 | |
Completed |
NCT01535599 -
Safety and Efficacy Evaluation of Topical AL-60371 Otic Suspension, 0.3% in the Treatment of Acute Otitis Externa
|
Phase 3 | |
Completed |
NCT02801370 -
Phase 3 Study of OTO-201 in Acute Otitis Externa
|
Phase 3 | |
Completed |
NCT00750633 -
A Phase III Study of an Otic Formulation in Acute Otitis Externa
|
Phase 3 | |
Terminated |
NCT00945802 -
FST-201 In The Treatment of Acute Otitis Externa
|
Phase 3 | |
Completed |
NCT03196973 -
Efficacy and Safety of DF289 Plus DF277 Otic Solution in the Treatment of Acute Otitis Externa
|
Phase 3 | |
Recruiting |
NCT01584271 -
Study of Ear Comfort Ear Drops to Treat AOE Cases Compared to DexOtic & Otidin(R)
|
Phase 2 | |
Completed |
NCT02216071 -
Comparative Efficacy and Safety of Ciprofloxacin 0.3% and Dexamethasone 0.1% in Acute Otitis Externa
|
Phase 3 | |
Completed |
NCT00961675 -
FST-201 in the Treatment of Acute Otitis Externa
|
Phase 3 | |
Completed |
NCT01535560 -
Safety and Efficacy Evaluation of Topical AL-60371 Otic Suspension, 0.3% in the Treatment of Acute Otitis Externa
|
Phase 3 |