Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 84 of 433 for:    OTITIS

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01447017
Recruitment Status : Completed
First Posted : October 5, 2011
Results First Posted : December 10, 2013
Last Update Posted : December 10, 2013
Sponsor:
Collaborator:
Pergamum AB
Information provided by (Responsible Party):
DermaGen AB

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Acute Otitis Externa
Interventions Drug: DPK-060
Drug: Placebo for DPK-060 ear drops
Enrollment 69
Recruitment Details 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  
Arm/Group Title DPK-060 2% Ear Drops Placebo for DPK-060 Ear Drops
Hide Arm/Group Description 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, 0.3 mL/pipette, 3 times daily for 7 or 10 days (as applicable).
Period Title: Overall Study
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.
Arm/Group Title DPK-060 2% Ear Drops Placebo for DPK-060 Ear Drops Total
Hide Arm/Group Description 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, 0.3 mL/pipette, 3 times daily for 7 or 10 days (as applicable). Total of all reporting groups
Overall Number of Baseline Participants 45 24 69
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 45 participants 24 participants 69 participants
55.0  (16.8) 58.1  (12.3) 56.2  (15.3)
[1]
Measure Description: Based on the Full Analysis Set
Gender   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 45 participants 24 participants 69 participants
Female 26 13 39
Male 14 11 25
[1]
Measure Description: Based on the Full Analysis Set
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Sweden Number Analyzed 45 participants 24 participants 69 participants
45 24 69
1.Primary Outcome
Title Adverse Events (AEs)
Hide Description 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.
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".
Hide Outcome Measure Data
Hide Analysis Population Description
All safety analyses were performed on safety analysis set. All randomised patients who received at least 1 dose of the IMP and had at least 1 safety follow-up performed were included in the safety analysis set.
Arm/Group Title DPK-060 2% Ear Drops Placebo for DPK-060 Ear Drops
Hide Arm/Group Description:
Patients randomized to treatment with DPK-060 2% ear drops (0.3 mL/pipette, 3 times daily for 7 or 10 days, as applicable)
Patients randomized to treatment with Placebo for DPK-060 ear drops (0.3 mL/pipette, 3 times daily for 7 or 10 days, as applicable)
Overall Number of Participants Analyzed 42 24
Measure Type: Number
Unit of Measure: participants
Number patients with at least one AE 10 3
Number of patients with at least one related AE 6 1
Number patients with at least one SAE 0 0
Number of patients who withdrew due to AE 1 0
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 product, previously reported AEs were followed up and assessed as "recovered" or "not recovered"
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title DPK-060 2% Ear Drops Placebo for DPK-060 Ear Drops
Hide Arm/Group Description 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, 0.3 mL/pipette, 3 times daily for 7 or 10 days (as applicable).
All-Cause Mortality
DPK-060 2% Ear Drops Placebo for DPK-060 Ear Drops
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
DPK-060 2% Ear Drops Placebo for DPK-060 Ear Drops
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/42 (0.00%)      0/24 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
DPK-060 2% Ear Drops Placebo for DPK-060 Ear Drops
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/42 (9.52%)      2/24 (8.33%)    
General disorders     
Application site pain  3/42 (7.14%)  3 0/24 (0.00%)  0
Nervous system disorders     
Headache  1/42 (2.38%)  1 2/24 (8.33%)  2
1
Term from vocabulary, MedDRA (14.0)
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 following disclosure restriction on the PI was included in clinical study protocol:

"If an Investigator wishes to publish results from this clinical study, written permission to publish must be obtained from the Sponsor in advance. As some of the information regarding the IP and development activities at the Sponsor may be of a strictly confidential nature, the Sponsor must first review any publication manuscript prior to their submission to journals, meetings or conferences."

Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Pekka Koskinen
Organization: Centre for Clinical Studies in Malmö
Phone: +46 (0)40 97 12 60
EMail: pekka@clsm.se
Layout table for additonal information
Responsible Party: DermaGen AB
ClinicalTrials.gov Identifier: NCT01447017     History of Changes
Other Study ID Numbers: DCS-002
2011-004356-20 ( EudraCT Number )
First Submitted: September 22, 2011
First Posted: October 5, 2011
Results First Submitted: October 18, 2013
Results First Posted: December 10, 2013
Last Update Posted: December 10, 2013