Clinical trial NCT01447017: A Study of DPK-060 to Investigate Clinical Safety and Efficacy in Patients With Acute External Otitis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Otitis Externa
Lead sponsor: DermaGen AB
Sponsor class: INDUSTRY
Collaborators: name: Pergamum AB
First posted: 2011-10-05
Enrollment: 69
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Adverse Events (AEs)
timeFrame: 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".
Secondary outcomes:
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Hagakliniken
city: Gothenburg
country: Sweden
facility: Me3+ Clinical Trials
city: Halmstad
country: Sweden
facility: Hallands Sjukhus
city: Lund
country: Sweden
facility: ProbarE
city: Malmö
country: Sweden
facility: Curakliniken
city: Stockholm
country: Sweden
facility: S3 Clinical Research Center, Vällingby
city: Stockholm
country: Sweden
facility: Värmdö vårdcentral
Study officials:
affiliation: S3 Clinical Research Center, Vällingby
name: Bo Liu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Värmdö vårdcentral
name: Andrzej Sloma, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Me3+ Clinical Trials, Gothenburg
name: Dan Curiac, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hagakliniken, Gothenburg
name: Ali Hajimirsadeghi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: ProbarE, Lund
name: Anders Luts, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Halmstad Lasarett ÖNH Mottagningen
name: Finn Jörgensen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Curakliniken, Öronmottagningen, Malmö
name: Madeleine Cosmo, MD
role: PRINCIPAL_INVESTIGATOR
References: