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

October 18, 2013 updated by: DermaGen AB

A Randomised, Parallel-group, Double-blind, Placebo-controlled Study of DPK-060 to Investigate Clinical Safety and Efficacy in Patients With Acute External Otitis

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.

Study Overview

Status

Completed

Study Type

Interventional

Enrollment (Actual)

69

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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).
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 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).
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events (AEs)
Time Frame: 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".
AEs were 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. All AEs including but not limited to events reported by the patient, or reported in answer to an open question by the Investigator or member of the study team were 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.
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".

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

September 22, 2011

First Submitted That Met QC Criteria

October 4, 2011

First Posted (Estimate)

October 5, 2011

Study Record Updates

Last Update Posted (Estimate)

December 10, 2013

Last Update Submitted That Met QC Criteria

October 18, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • DCS-002
  • 2011-004356-20 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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