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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-004356-20 | EudraCT Number |
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| Name | Class |
|---|---|
| Pergamum AB | INDUSTRY |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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". |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hagakliniken | Gothenburg | Sweden | ||||
| Me3+ Clinical Trials |
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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
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| ID | Title | Description |
|---|---|---|
| FG000 | DPK-060 2% Ear Drops | DPK-060 2% ear drops, 0.3 mL/pipette, 3 times daily for 7 or 10 days (as applicable). |
| FG001 | Placebo for DPK-060 Ear Drops | Placebo for DPK-060 ear drops, 0.3 mL/pipette, 3 times daily for 7 or 10 days (as applicable). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | DPK-060 2% Ear Drops | DPK-060 2% ear drops, 0.3 mL/pipette, 3 times daily for 7 or 10 days (as applicable). |
| BG001 | Placebo for DPK-060 Ear Drops | Placebo for DPK-060 ear drops, 0.3 mL/pipette, 3 times daily for 7 or 10 days (as applicable). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Based on the Full Analysis Set |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All safety analyses were performed on safety analysis set. All randomised patients who received at least 1 dose of the IMP and had at least 1 safety follow-up performed were included in the safety analysis set. | Posted | Number | participants | 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 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"
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DPK-060 2% Ear Drops | DPK-060 2% ear drops, 0.3 mL/pipette, 3 times daily for 7 or 10 days (as applicable). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application site pain | General disorders | MedDRA (14.0) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Pekka Koskinen | Centre for Clinical Studies in Malmö | +46 (0)40 97 12 60 | pekka@clsm.se |
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|
| 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. |
|
| Gothenburg |
| Sweden |
| Hallands Sjukhus | Halmstad | 30185 | Sweden |
| ProbarE | Lund | Sweden |
| Curakliniken | Malmö | 20037 | Sweden |
| S3 Clinical Research Center, Vällingby | Stockholm | Sweden |
| Värmdö vårdcentral | Stockholm | Sweden |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Gender | Based on the Full Analysis Set | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| OG000 | DPK-060 2% Ear Drops | Patients randomized to treatment with DPK-060 2% ear drops (0.3 mL/pipette, 3 times daily for 7 or 10 days, as applicable) |
| OG001 | Placebo for DPK-060 Ear Drops | Patients randomized to treatment with Placebo for DPK-060 ear drops (0.3 mL/pipette, 3 times daily for 7 or 10 days, as applicable) |
|
|
| 0 |
| 42 |
| 4 |
| 42 |
| EG001 | Placebo for DPK-060 Ear Drops | Placebo for DPK-060 ear drops, 0.3 mL/pipette, 3 times daily for 7 or 10 days (as applicable). | 0 | 24 | 2 | 24 |
| Headache | Nervous system disorders | MedDRA (14.0) |
|
The following disclosure restriction on the PI was included in clinical study protocol:
"If an Investigator wishes to publish results from this clinical study, written permission to publish must be obtained from the Sponsor in advance. As some of the information regarding the IP and development activities at the Sponsor may be of a strictly confidential nature, the Sponsor must first review any publication manuscript prior to their submission to journals, meetings or conferences."