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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:
Sponsor: DermaGen AB

Current Primary Outcome: 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.


Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: DermaGen AB

Dates:
Date Received: September 22, 2011
Date Started: November 2011
Date Completion:
Last Updated: October 18, 2013
Last Verified: October 2013