A Study of DPK-060 to Investigate Clinical Safety and Efficacy in Patients With Acute External Otitis
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|ClinicalTrials.gov Identifier: NCT01447017|
Recruitment Status : Completed
First Posted : October 5, 2011
Results First Posted : December 10, 2013
Last Update Posted : December 10, 2013
|Condition or disease||Intervention/treatment||Phase|
|Acute Otitis Externa||Drug: DPK-060 Drug: Placebo for DPK-060 ear drops||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||69 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||November 2011|
|Actual Primary Completion Date :||October 2012|
|Actual Study Completion Date :||November 2012|
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).
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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01447017
|Me3+ Clinical Trials|
|Halmstad, Sweden, 30185|
|Malmö, Sweden, 20037|
|S3 Clinical Research Center, Vällingby|
|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|