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

NCT01447017 | Completed Phase 2 Results

• 2 other identifiers: DCS-0022011-004356-20
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 7

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.

Conditions

Acute Otitis Externa

Outcome Measures

Primary Outcomes (1)

• 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".

Study Arms (2)

DPK-060 2% ear drops

EXPERIMENTAL

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

Drug: DPK-060

Placebo for DPK-060 ear drops

PLACEBO COMPARATOR

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

Drug: Placebo for DPK-060 ear drops

Interventions

DPK-060 DRUG

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.

DPK-060 2% ear drops

Placebo for DPK-060 ear drops DRUG

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.

Placebo for DPK-060 ear drops

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• A clinical diagnosis of acute external otitis of a severity degree not requiring specialist care
• Age 12 years and older

You may not qualify if:

• 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

Sponsors & Collaborators

• DermaGen AB: lead
• Pergamum AB: collaborator

Study Sites (7)

Hagakliniken

Gothenburg, Sweden

Location

Me3+ Clinical Trials

Gothenburg, Sweden

Location

Hallands Sjukhus

Halmstad, 30185, Sweden

Location

ProbarE

Lund, Sweden

Location

Curakliniken

Malmo, 20037, Sweden

Location

S3 Clinical Research Center, Vällingby

Stockholm, Sweden

Location

Värmdö vårdcentral

Stockholm, Sweden

Location

Results Point of Contact

• Title: Dr. Pekka Koskinen
• Organization: Centre for Clinical Studies in Malmö

pekka@clsm.se

+46 (0)40 97 12 60

Study Officials

• Bo Liu, MD

  S3 Clinical Research Center, Vällingby

  PRINCIPAL INVESTIGATOR

• Andrzej Sloma, MD

  Värmdö vårdcentral

  PRINCIPAL INVESTIGATOR

• Dan Curiac, MD

  Me3+ Clinical Trials, Gothenburg

  PRINCIPAL INVESTIGATOR

• Ali Hajimirsadeghi, MD

  Hagakliniken, Gothenburg

  PRINCIPAL INVESTIGATOR

• Anders Luts, MD

  ProbarE, Lund

  PRINCIPAL INVESTIGATOR

• Finn Jörgensen, MD

  Halmstad Lasarett ÖNH Mottagningen

  PRINCIPAL INVESTIGATOR

• Madeleine Cosmo, MD

  Curakliniken, Öronmottagningen, Malmö

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2011
• First Posted: October 5, 2011
• Study Start: November 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: November 1, 2012
• Last Updated: December 10, 2013
• Results First Posted: December 10, 2013

Record last verified: 2013-10

Locations

SE (7)