Acute Otitis ExternaPhase 2NCT01447017
A Study of DPK-060 to Investigate Clinical Safety and Efficacy in Patients With Acute External Otitis
A Phase 2 study testing DPK-060 in people with Acute Otitis Externa, run by DermaGen AB at 7 sites in Sweden.
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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Acute Otitis Externa
- What is being tested?
- DPK-060
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 7 sitesSweden
- Study dates
- Nov 2011to Nov 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- A clinical diagnosis of acute external otitis of a severity degree not requiring specialist care
- Age 12 years and older
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Sweden7 sites
Hagakliniken
Gothenburg
Me3+ Clinical Trials
Gothenburg
Hallands Sjukhus
Halmstad, 30185
ProbarE
Lund
Curakliniken
Malmö, 20037
S3 Clinical Research Center, Vällingby
Stockholm
Värmdö vårdcentral
Stockholm
About this study
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
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
- Being tested
- DPK-060, Placebo for DPK-060 ear drops
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DPK-060Drug
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 dropsDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Drug: Placebo for DPK-060 ear drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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".
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2011 (estimated)
- Study startNov 2011
- Primary completionOct 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Otitis ExternaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- DermaGen AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pergamum AB
- Responsible party
- Sponsor
- Investigators
- Bo Liu, MD, Principal investigator, S3 Clinical Research Center, VällingbyAndrzej Sloma, MD, Principal investigator, Värmdö vårdcentralDan Curiac, MD, Principal investigator, Me3+ Clinical Trials, GothenburgAli Hajimirsadeghi, MD, Principal investigator, Hagakliniken, GothenburgAnders Luts, MD, Principal investigator, ProbarE, LundFinn Jörgensen, MD, Principal investigator, Halmstad Lasarett ÖNH MottagningenMadeleine Cosmo, MD, Principal investigator, Curakliniken, Öronmottagningen, Malmö
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01447017
- Sponsor's protocol ID
- DCS-002
- Other IDs
- 2011-004356-20
- Status last verified
- Oct 2013
- First submitted
- 22 Sep 2011
- Last updated
- 10 Dec 2013
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01447017
- Acronym / sponsor ID
- DCS-002
- Conditions
- Acute Otitis Externa
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- DermaGen ABIndustry (pharma, biotech, devices)
- Collaborators
- Pergamum AB
- Study start
- Nov 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 5 Oct 2011 (estimated)
- Results
- Posted 10 Dec 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DPK-060 2% ear drops | Experimental | Drug: DPK-060DPK-060 2% ear drops, 0.3 mL/pipette, 3 times daily for 7 or 10 days (as applicable). |
| Placebo for DPK-060 ear drops | Placebo comparator | Drug: Placebo for DPK-060 ear dropsPlacebo for DPK-060 ear drops, 0.3 mL/pipette, 3 times daily for 7 or 10 days (as applicable). |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- A clinical diagnosis of acute external otitis of a severity degree not requiring specialist care
- Age 12 years and older
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DPK-060DPK-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 | DPK-060 2% ear drops |
| Placebo for DPK-060 ear dropsPlacebo 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. | Drug | Placebo for DPK-060 ear drops |
Primary outcome
Adverse Events (AEs)
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".
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bo Liu, MD principal investigator
S3 Clinical Research Center, Vällingby
Andrzej Sloma, MD principal investigator
Värmdö vårdcentral
Dan Curiac, MD principal investigator
Me3+ Clinical Trials, Gothenburg
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DPK-060 in people with Acute Otitis Externa, run by DermaGen AB at 7 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (AEs) (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".). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2013.