A Study of DPK-060 to Investigate Clinical Safety and Efficacy in Patients With Acute External Otitis - Full Text View

Purpose

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.

Condition	Intervention	Phase
Acute Otitis Externa	Drug: DPK-060 Drug: Placebo for DPK-060 ear drops	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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

Resource links provided by NLM:

Drug Information available for: Carbamide Carbamide peroxide

U.S. FDA Resources

Further study details as provided by DermaGen AB:

Primary Outcome Measures:

Adverse Events (AEs) [ Time Frame: AEs occurring during the treatment period will be collected on day 8 or 11, as applicable. Four weeks after the last dose of investigational product, previously reported AEs will be followed up and assessed as "recovered" or "not recovered". ] [ Designated as safety issue: Yes ]
AEs will be 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. Events reported by the patient, or reported in answer to an open question by the Investigator or member of the study team will be 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.

Enrollment:	69
Study Start Date:	November 2011
Primary Completion Date:	October 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: DPK-060 2% ear drops DPK-060 2% ear drops, 0.3 mL/pipette, 3 times daily for 7 or 10 days (as applicable).	Drug: DPK-060 DPK-060 2% ear drops will be 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 should remain after 7 days of treatment, the treatment period will be extended by another 3 days with 3 applications per day.
Placebo Comparator: 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).	Drug: Placebo for DPK-060 ear drops Placebo for DPK 060 ear drops will be 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 should remain after 7 days of treatment, the treatment period will be extended by another 3 days with 3 applications per day.

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01447017

Locations

Sweden
Me3+ Clinical Trials
Gothenburg, Sweden
Hagakliniken
Gothenburg, Sweden
Hallands Sjukhus
Halmstad, Sweden, 30185
ProbarE
Lund, Sweden
Curakliniken
Malmö, Sweden, 20037
S3 Clinical Research Center, Vällingby
Stockholm, Sweden
Värmdö vårdcentral
Stockholm, Sweden

Sponsors and Collaborators

DermaGen AB

Pergamum AB

Investigators

Principal Investigator:	Bo Liu, MD	S3 Clinical Research Center, Vällingby
Principal Investigator:	Andrzej Sloma, MD	Värmdö vårdcentral
Principal Investigator:	Dan Curiac, MD	Me3+ Clinical Trials, Gothenburg
Principal Investigator:	Ali Hajimirsadeghi, MD	Hagakliniken, Gothenburg
Principal Investigator:	Anders Luts, MD	ProbarE, Lund
Principal Investigator:	Finn Jörgensen, MD	Halmstad Lasarett ÖNH Mottagningen
Principal Investigator:	Madeleine Cosmo, MD	Curakliniken, Öronmottagningen, Malmö

More Information

No publications provided

Responsible Party:	DermaGen AB
ClinicalTrials.gov Identifier:	NCT01447017 History of Changes
Other Study ID Numbers:	DCS-002, 2011-004356-20
Study First Received:	September 22, 2011
Last Updated:	October 29, 2012
Health Authority:	Sweden: Medical Products Agency

Additional relevant MeSH terms:

Otitis Externa
Otitis
Ear Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on May 16, 2013