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

September 22, 2011
October 18, 2013
November 2011
October 2012   (final data collection date for primary outcome measure)
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.
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Complete list of historical versions of study NCT01447017 on ClinicalTrials.gov Archive Site
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A Study of DPK-060 to Investigate Clinical Safety and Efficacy in Patients With Acute External Otitis
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Acute Otitis Externa
  • 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.
  • 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).
    Intervention: Drug: DPK-060
  • 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).
    Intervention: Drug: Placebo for DPK-060 ear drops
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
69
November 2012
October 2012   (final data collection date for primary outcome measure)

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
Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01447017
DCS-002, 2011-004356-20
Not Provided
DermaGen AB
DermaGen AB
Pergamum AB
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
DermaGen AB
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP