A Phase 2 interventional study of DPK-060 and Placebo for DPK-060 ear drops in Acute Otitis Externa, sponsored by DermaGen AB. Completed at 7 sites in Sweden. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2013-12-10.
Sponsored by DermaGen AB · Phase 2, Interventional, and Treatment
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.
Exclusion Criteria:
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, 0.3 mL/pipette, 3 times daily for 7 or 10 days (as applicable).
Drug: Placebo for DPK-060 ear drops
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 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.
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.
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".
Male and female patients, aged 12 years and above, with a clinical diagnosis of acute external otitis of a severity that is normally treated by primary care were included in the study. The first patient entered the study on January 2012 and the last patient completed the study on November 2012
| Milestone | DPK-060 2% Ear Drops | Placebo for DPK-060 Ear Drops |
|---|---|---|
| Started | 45 | 24 |
| Performed visit 2 | 43 | 24 |
| Completed | 35 | 14 |
| Not completed | 10 | 10 |
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.
| participants | DPK-060 2% Ear Drops | Placebo for DPK-060 Ear Drops |
|---|---|---|
| Number patients with at least one AE | 10 | 3 |
| Number of patients with at least one related AE | 6 | 1 |
| Number patients with at least one SAE | 0 | 0 |
| Number of patients who withdrew due to AE | 1 | 0 |
Collected over AEs occurring during the treatment period were collected on day 8 or 11, as applicable. Four weeks after the last dose of investigational product, previously reported AEs were followed up and assessed as "recovered" or "not recovered". Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| DPK-060 2% Ear Drops | — | 0/42 (0%) | 4/42 (9.5%) |
| Placebo for DPK-060 Ear Drops | — | 0/24 (0%) | 2/24 (8.3%) |
| Event | DPK-060 2% Ear Drops | Placebo for DPK-060 Ear Drops |
|---|---|---|
| HeadacheNervous system disorders | 1/42 | 2/24 |
| Application site painGeneral disorders | 3/42 | 0/24 |
| Age Continuous(years) | DPK-060 2% Ear Drops | Placebo for DPK-060 Ear Drops | Total |
|---|---|---|---|
| Mean | 55.0 ± 16.8 | 58.1 ± 12.3 | 56.2 ± 15.3 |
| Gender(participants) | DPK-060 2% Ear Drops | Placebo for DPK-060 Ear Drops | Total |
|---|---|---|---|
| Female | 26 | 13 | 39 |
| Male | 14 | 11 | 25 |
| Region of Enrollment(participants) | DPK-060 2% Ear Drops | Placebo for DPK-060 Ear Drops | Total |
|---|---|---|---|
| Sweden | 45 | 24 | 69 |
This study is completed, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.
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