A Study of DPK-060 to Investigate Clinical Safety and Efficacy in Patients With Acute External Otitis
NCT ID: NCT01447017
Last Updated: 2013-12-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
69 participants
INTERVENTIONAL
2011-11-30
2012-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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DPK-060 2% ear drops
DPK-060 2% ear drops, 0.3 mL/pipette, 3 times daily for 7 or 10 days (as applicable).
DPK-060
DPK-060 2% ear drops were administered as 3 applications per day into the outer ear by use of a single-dose pipette (0.3 mL/pipette) for 7 days. In case clinical symptoms remained after 7 days of treatment, the treatment period was extended by another 3 days with 3 applications per day.
Placebo for DPK-060 ear drops
Placebo for DPK-060 ear drops, 0.3 mL/pipette, 3 times daily for 7 or 10 days (as applicable).
Placebo for DPK-060 ear drops
Placebo for DPK-060 ear drops were administered as 3 applications per day into the outer ear by use of a single-dose pipette (0.3 mL/pipette) for 7 days. In case clinical symptoms remained after 7 days of treatment, the treatment period was extended by another 3 days with 3 applications per day.
Interventions
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DPK-060
DPK-060 2% ear drops were administered as 3 applications per day into the outer ear by use of a single-dose pipette (0.3 mL/pipette) for 7 days. In case clinical symptoms remained after 7 days of treatment, the treatment period was extended by another 3 days with 3 applications per day.
Placebo for DPK-060 ear drops
Placebo for DPK-060 ear drops were administered as 3 applications per day into the outer ear by use of a single-dose pipette (0.3 mL/pipette) for 7 days. In case clinical symptoms remained after 7 days of treatment, the treatment period was extended by another 3 days with 3 applications per day.
Eligibility Criteria
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Inclusion Criteria
* Age 12 years and older
Exclusion Criteria
* 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
12 Years
ALL
No
Sponsors
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Pergamum AB
INDUSTRY
DermaGen AB
INDUSTRY
Responsible Party
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Principal Investigators
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Bo Liu, MD
Role: PRINCIPAL_INVESTIGATOR
S3 Clinical Research Center, Vällingby
Andrzej Sloma, MD
Role: PRINCIPAL_INVESTIGATOR
Värmdö vårdcentral
Dan Curiac, MD
Role: PRINCIPAL_INVESTIGATOR
Me3+ Clinical Trials, Gothenburg
Ali Hajimirsadeghi, MD
Role: PRINCIPAL_INVESTIGATOR
Hagakliniken, Gothenburg
Anders Luts, MD
Role: PRINCIPAL_INVESTIGATOR
ProbarE, Lund
Finn Jörgensen, MD
Role: PRINCIPAL_INVESTIGATOR
Halmstad Lasarett ÖNH Mottagningen
Madeleine Cosmo, MD
Role: PRINCIPAL_INVESTIGATOR
Curakliniken, Öronmottagningen, Malmö
Locations
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Hagakliniken
Gothenburg, , Sweden
Me3+ Clinical Trials
Gothenburg, , Sweden
Hallands Sjukhus
Halmstad, , Sweden
ProbarE
Lund, , Sweden
Curakliniken
Malmo, , Sweden
S3 Clinical Research Center, Vällingby
Stockholm, , Sweden
Värmdö vårdcentral
Stockholm, , Sweden
Countries
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Other Identifiers
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2011-004356-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
DCS-002
Identifier Type: -
Identifier Source: org_study_id