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
Results First Received: October 18, 2013  
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
Condition: Acute Otitis Externa
Interventions: Drug: DPK-060
Drug: Placebo for DPK-060 ear drops

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Male and female patients, aged 12 years and above, with a clinical diagnosis of acute external otitis of a severity that is normally treated by primary care were included in the study. The first patient entered the study on January 2012 and the last patient completed the study on November 2012

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
DPK-060 2% Ear Drops DPK-060 2% ear drops, 0.3 mL/pipette, 3 times daily for 7 or 10 days (as applicable).
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).

Participant Flow:   Overall Study
    DPK-060 2% Ear Drops     Placebo for DPK-060 Ear Drops  
STARTED     45     24  
Performed Visit 2     43     24  
COMPLETED     35 [1]   14 [2]
NOT COMPLETED     10     10  
[1] In safety analysis: 42. In efficacy analyses: 40 in full analysis set, and 39 in per-protocol set.
[2] In safety analysis: 24. In efficacy analyses: 24 in full analysis set, and 22 in per-protocol set.



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
DPK-060 2% Ear Drops DPK-060 2% ear drops, 0.3 mL/pipette, 3 times daily for 7 or 10 days (as applicable).
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).
Total Total of all reporting groups

Baseline Measures
    DPK-060 2% Ear Drops     Placebo for DPK-060 Ear Drops     Total  
Number of Participants  
[units: participants]
  45     24     69  
Age [1]
[units: years]
Mean ± Standard Deviation
  55.0  ± 16.8     58.1  ± 12.3     56.2  ± 15.3  
Gender [1]
[units: participants]
     
Female     26     13     39  
Male     14     11     25  
Region of Enrollment  
[units: participants]
     
Sweden     45     24     69  
[1] Based on the Full Analysis Set



  Outcome Measures

1.  Primary:   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". ]


  Serious Adverse Events


  Other Adverse Events


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Dr. Pekka Koskinen
Organization: Centre for Clinical Studies in Malmö
phone: +46 (0)40 97 12 60
e-mail: pekka@clsm.se


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