Clinical Trials Logo

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


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
See also
  Status Clinical Trial Phase
Completed NCT02918773 - Pediatric Emergency Department Smartphone Otoscope Study (PED-Oto) N/A
Not yet recruiting NCT04636957 - A Phase III Study of Ciprofloxacin Plus Fluocinolone in Acute Otitis Externa (AOE) Phase 3
Completed NCT01535599 - Safety and Efficacy Evaluation of Topical AL-60371 Otic Suspension, 0.3% in the Treatment of Acute Otitis Externa Phase 3
Completed NCT02801370 - Phase 3 Study of OTO-201 in Acute Otitis Externa Phase 3
Completed NCT00750633 - A Phase III Study of an Otic Formulation in Acute Otitis Externa Phase 3
Terminated NCT00945802 - FST-201 In The Treatment of Acute Otitis Externa Phase 3
Completed NCT03196973 - Efficacy and Safety of DF289 Plus DF277 Otic Solution in the Treatment of Acute Otitis Externa Phase 3
Recruiting NCT01584271 - Study of Ear Comfort Ear Drops to Treat AOE Cases Compared to DexOtic & Otidin(R) Phase 2
Completed NCT02216071 - Comparative Efficacy and Safety of Ciprofloxacin 0.3% and Dexamethasone 0.1% in Acute Otitis Externa Phase 3
Completed NCT00961675 - FST-201 in the Treatment of Acute Otitis Externa Phase 3
Completed NCT01535560 - Safety and Efficacy Evaluation of Topical AL-60371 Otic Suspension, 0.3% in the Treatment of Acute Otitis Externa Phase 3