Back to results

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

Primary Purpose

Acute Otitis Externa

Status

Completed

Phase

Phase 2

Locations

Sweden

Study Type

Interventional

Intervention

DPK-060

Placebo for DPK-060 ear drops

About this trial

This is an interventional treatment trial for Acute Otitis Externa

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hagakliniken
Me3+ Clinical Trials
Hallands Sjukhus
ProbarE
Curakliniken
S3 Clinical Research Center, Vällingby
Värmdö vårdcentral

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

DPK-060 2% ear drops

Placebo for DPK-060 ear drops

Arm Description

DPK-060 2% ear drops, 0.3 mL/pipette, 3 times daily for 7 or 10 days (as applicable).

Placebo for DPK-060 ear drops, 0.3 mL/pipette, 3 times daily for 7 or 10 days (as applicable).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01447017

First Posted

September 22, 2011

Last Updated

October 18, 2013

Sponsor

DermaGen AB

Collaborators

Pergamum AB

1. Study Identification

Unique Protocol Identification Number

NCT01447017

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

October 2013

Overall Recruitment Status

Completed

Study Start Date

November 2011 (undefined)

Primary Completion Date

October 2012 (Actual)

Study Completion Date

November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

DermaGen AB

Collaborators

Pergamum AB

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Otitis Externa

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

69 (Actual)

8. Arms, Groups, and Interventions

Arm Title

DPK-060 2% ear drops

Arm Type

Experimental

Arm Description

DPK-060 2% ear drops, 0.3 mL/pipette, 3 times daily for 7 or 10 days (as applicable).

Arm Title

Placebo for DPK-060 ear drops

Arm Type

Placebo Comparator

Arm Description

Placebo for DPK-060 ear drops, 0.3 mL/pipette, 3 times daily for 7 or 10 days (as applicable).

Intervention Type

Drug

Intervention Name(s)

DPK-060

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Placebo for DPK-060 ear drops

Intervention Description

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.

Primary Outcome Measure Information:

Title

Adverse Events (AEs)

Description

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".

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials: