Trial Outcomes & Findings for A Study of DPK-060 to Investigate Clinical Safety and Efficacy in Patients With Acute External Otitis (NCT NCT01447017)
NCT ID: NCT01447017
Last Updated: 2013-12-10
Results Overview
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.
COMPLETED
PHASE2
69 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".
2013-12-10
Participant Flow
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
Participant milestones
| Measure |
DPK-060 2% Ear Drops
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 for DPK-060 ear drops, 0.3 mL/pipette, 3 times daily for 7 or 10 days (as applicable).
|
|---|---|---|
|
Overall Study
STARTED
|
45
|
24
|
|
Overall Study
Performed Visit 2
|
43
|
24
|
|
Overall Study
COMPLETED
|
35
|
14
|
|
Overall Study
NOT COMPLETED
|
10
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of DPK-060 to Investigate Clinical Safety and Efficacy in Patients With Acute External Otitis
Baseline characteristics by cohort
| Measure |
DPK-060 2% Ear Drops
n=45 Participants
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
n=24 Participants
Placebo for DPK-060 ear drops, 0.3 mL/pipette, 3 times daily for 7 or 10 days (as applicable).
|
Total
n=69 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
55.0 years
STANDARD_DEVIATION 16.8 • n=5 Participants
|
58.1 years
STANDARD_DEVIATION 12.3 • n=7 Participants
|
56.2 years
STANDARD_DEVIATION 15.3 • n=5 Participants
|
|
Gender
Female
|
26 participants
n=5 Participants
|
13 participants
n=7 Participants
|
39 participants
n=5 Participants
|
|
Gender
Male
|
14 participants
n=5 Participants
|
11 participants
n=7 Participants
|
25 participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
45 participants
n=5 Participants
|
24 participants
n=7 Participants
|
69 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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".Population: 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.
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.
Outcome measures
| Measure |
DPK-060 2% Ear Drops
n=42 Participants
Patients randomized to treatment with 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
n=24 Participants
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)
|
|---|---|---|
|
Adverse Events (AEs)
Number patients with at least one AE
|
10 participants
|
3 participants
|
|
Adverse Events (AEs)
Number of patients with at least one related AE
|
6 participants
|
1 participants
|
|
Adverse Events (AEs)
Number patients with at least one SAE
|
0 participants
|
0 participants
|
|
Adverse Events (AEs)
Number of patients who withdrew due to AE
|
1 participants
|
0 participants
|
Adverse Events
DPK-060 2% Ear Drops
Placebo for DPK-060 Ear Drops
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
DPK-060 2% Ear Drops
n=42 participants at risk
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
n=24 participants at risk
Placebo for DPK-060 ear drops, 0.3 mL/pipette, 3 times daily for 7 or 10 days (as applicable).
|
|---|---|---|
|
General disorders
Application site pain
|
7.1%
3/42 • Number of events 3 • 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"
|
0.00%
0/24 • 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"
|
|
Nervous system disorders
Headache
|
2.4%
1/42 • Number of events 1 • 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"
|
8.3%
2/24 • Number of events 2 • 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"
|
Additional Information
Dr. Pekka Koskinen
Centre for Clinical Studies in Malmö
Results disclosure agreements
- Principal investigator is a sponsor employee 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."
- Publication restrictions are in place
Restriction type: OTHER