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

NCT01447017 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2013-12-10

Study results available
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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.

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.

Sponsors & Collaborators

  • Pergamum AB

    collaborator INDUSTRY

  • DermaGen AB

    lead INDUSTRY

Principal Investigators

  • Bo Liu, MD · S3 Clinical Research Center, Vällingby

  • Andrzej Sloma, MD · Värmdö vårdcentral

  • Dan Curiac, MD · Me3+ Clinical Trials, Gothenburg

  • Ali Hajimirsadeghi, MD · Hagakliniken, Gothenburg

  • Anders Luts, MD · ProbarE, Lund

  • Finn Jörgensen, MD · Halmstad Lasarett ÖNH Mottagningen

  • Madeleine Cosmo, MD · Curakliniken, Öronmottagningen, Malmö

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2012-10-31
Completion
2012-11-30

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01447017 on ClinicalTrials.gov