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

This study has been completed.
Sponsor:
Collaborator:
Pergamum AB
Information provided by (Responsible Party):
DermaGen AB
ClinicalTrials.gov Identifier:
NCT01447017
First received: September 22, 2011
Last updated: October 18, 2013
Last verified: October 2013
  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:


Further study details as provided by DermaGen AB:

Primary Outcome Measures:
  • 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". ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 69
Study Start Date: November 2011
Study Completion Date: November 2012
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 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).
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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Sweden
Hagakliniken
Gothenburg, Sweden
Me3+ Clinical Trials
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
Results First Received: October 18, 2013
Last Updated: October 18, 2013
Health Authority: Sweden: Medical Products Agency

Additional relevant MeSH terms:
Otitis
Otitis Externa
Ear Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on October 29, 2014