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". ]
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