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

Acute Otitis Externa Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01447017
• Other study ID #: DCS-002
• Secondary ID: 2011-004356-20
• Status: Completed
• Phase: Phase 2
• First received: September 22, 2011
• Last updated: October 18, 2013
• Start date: November 2011
• Est. completion date: November 2012

Study information

• Verified date: October 2013
• Source: DermaGen AB
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: November 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Otitis Externa
• Otitis
• Otitis Externa

Intervention

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.
• 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.

Locations

Country	Name	City	State
Sweden	Hagakliniken	Gothenburg
Sweden	Me3+ Clinical Trials	Gothenburg
Sweden	Hallands Sjukhus	Halmstad
Sweden	ProbarE	Lund
Sweden	Curakliniken	Malmö
Sweden	S3 Clinical Research Center, Vällingby	Stockholm
Sweden	Värmdö vårdcentral	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
DermaGen AB	Pergamum AB

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events (AEs)	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".	Yes