- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01447017
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
Conditions
Intervention / Treatment
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
Additional Relevant MeSH Terms
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.
Clinical Trials on Acute Otitis Externa
-
Alcon ResearchCompleted
-
Alcon ResearchCompleted
-
ShireCompleted
-
Exela Pharma Sciences, LLC.CompletedComparative Efficacy and Safety of Ciprofloxacin 0.3% and Dexamethasone 0.1% in Acute Otitis ExternaAcute Otitis ExternaUnited States, Puerto Rico
-
SalvatCompletedAcute Otitis ExternaSpain
-
Otonomy, Inc.CompletedAcute Otitis Externa | Swimmer's EarUnited States, Canada
-
ShireTerminated
-
Lee's Pharmaceutical LimitedUnknownAcute Otitis ExternaChina
-
Emory UniversityChildren's Healthcare of Atlanta; Georgia Institute of TechnologyCompletedAcute Otitis Externa | Acute Otitis MediaUnited States
-
ShireTerminated
Clinical Trials on DPK-060
-
DermaGen ABCompleted
-
Pieris Australia Pty LtdCompletedStudy of a Single Dose of PRS-060 Administered by Oral Inhalation or IV Infusion in Healthy SubjectsHealthy SubjectsAustralia
-
Bristol-Myers SquibbWithdrawnLymphoma, Large-CellUnited States, France
-
Pieris Australia Pty LtdCompleted
-
PfizerCompletedNeoplasms | Carcinoma | Cancer | Advanced Solid Tumors | MalignancyUnited States
-
AstraZenecaCompletedAsthmaUnited Kingdom
-
PfizerTerminated
-
Bristol-Myers SquibbCompletedHodgkin's DiseaseUnited States
-
AO GENERIUMRecruitingST Elevation Myocardial InfarctionRussian Federation