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.
22 studies on the registry are indexed under Otitis Externa; 1 is open to participants now.
This study's enrollment of 69 is below the median of 100 across 20 interventional studies indexed under Otitis Externa.
Browse Otitis Externa studies →DermaGen AB is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Clinically significant
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Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
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Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
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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 |
The record gives a start of Nov 2011, a primary completion of Oct 2012 and a completion of Nov 2012. It does not say whether these dates are actual or estimated.
Results were first posted in Dec 2013, 1 year 2 months after primary completion.
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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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