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

PHASE2CompletedINTERVENTIONAL
Enrollment

69

Participants

Timeline

Start Date

November 30, 2011

Primary Completion Date

October 31, 2012

Study Completion Date

November 30, 2012

Conditions
Acute Otitis Externa
Interventions
DRUG

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.

DRUG

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.

Trial Locations (7)

20037

Curakliniken, Malmo

30185

Hallands Sjukhus, Halmstad

Unknown

Hagakliniken, Gothenburg

Me3+ Clinical Trials, Gothenburg

ProbarE, Lund

S3 Clinical Research Center, Vällingby, Stockholm

Värmdö vårdcentral, Stockholm

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Pergamum AB

INDUSTRY

lead

DermaGen AB

INDUSTRY