NCT01447017

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

A Randomised, Parallel-group, Double-blind, Placebo-controlled Study of DPK-060 to Investigate Clinical Safety and Efficacy in Patients With Acute External Otitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: DermaGen AB · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Otitis Externa

Interventions

Type	Name	Description
DRUG	DPK-060	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.
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.

Timeline

• Start date: 2011-11-01
• Primary completion: 2012-10-01
• Completion: 2012-11-01
• First posted: 2011-10-05
• Last updated: 2013-12-10
• Results posted: 2013-12-10

Locations

7 sites across 1 country: Sweden