Acute external otitis (EO)
Conditions
Interventions
Product Name: DPK-060
Product Code: DPK-060
Pharmaceutical Form: Ear drops, solution
Current Sponsor code: DPK-060
Other descriptive name: DPK-060
Concentration unit: % (W/W) percent weight/weight
Con
Sponsors
Pergamum AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The patients have to meet all of the following criteria to be eligible to enter the study: 1) Signed written informed consent prior to performing any study-related procedures. 2) A clinical diagnosis of acute EO based on clinical observation and a degree of disease severity normally treated by primary care (and not inducing referral to specialist care). 3) Age =12 years. 4) Female patients who have been post-menopausal for more than one year. Female patients =17 years of childbearing potential must agree to avoid pregnancy during the study period. If deemed necessary by the Investigator, they must also have a negative urine pregnancy test and agree to use adequate acceptable contraceptive measures (e.g. sterilisation, hormone implants, hormone injections, some intrauterine devices, vasectomised partner or combined birth control pills), during the study period. Female patients =18 years of childbearing potential must have a negative urine pregnancy test and, if sexually active, agree to use adequate acceptable contraceptive measures (e.g. sterilisation, hormone implants, hormone injections, some intrauterine devices, vasectomised partner or combined birth control pills), as judged by the Investigator, during the study period. Are the trial subjects under 18? yes Number of subjects for this age range: 30 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 9
Exclusion criteria
Exclusion criteria: Patients meeting any of the following criteria will not be permitted to enter the study: 1) Known or suspected allergy or sensitivity to any of the IPs or excipients. 2) Known or suspected perforation of the tympanic membrane. 3) A clinical diagnosis of chronic suppurative otitis media, acute otitis media, acute otorrhea or malignant otitis externa. 4) Local ear canal abnormalities such as abscess, granulation or polyps. 5) Congenital abnormalities of the EAC or obstructive bony exostosis. 6) Mastoiditis or suppurative non-infectious ear disorders (e.g. cholesteatoma). 7) Malignant tumour of the EAC. 8) History of otologic surgery (except for surgery confined to the temporomandibular joint). 9) Seborrheic dermatitis or other dermatological conditions of the EAC that would complicate evaluation. 10) Current or prior use (within 7 days) of ear washes using alcohol, vinegar or other astringents. 11) Any clinically relevant past or present infectious/viral disease, including hepatitis B or C and HIV, which in the opinion of the Investigator may put the patient at risk because of participation in the study, or may influence the results of the study. 12) Current infection requiring systemic antimicrobial therapy. 13) Current or prior use of systemic (within 14 days) or topical (within 7 days) antibiotics. 14) Current or prior use of systemic (within 30 days) or topical (within 7 days) steroids. 15) History of immune dysfunction/deficiency and immunosuppressive therapy. 16) Diabetes mellitus. 17) Any other clinically relevant past or present disease or disorder e.g. cardiovascular, pulmonary, gastrointerstinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment, which in the opinion of the Investigator may put the patient at risk because of participation in the study, or may influence the results of the study, or the patient’s ability to participate in the study. 18) Any clinically relevant abnormal findings in physical examination or vital signs, which in the opinion of the Investigator may put the patient at risk because of participation in the study, or may influence the results of the study, or the patient’s ability to participate in the study. 19) Current enrolment in an investigational drug or device study or participation in such a study within 30 days of entry into this study. 20) Previous randomisation to treatment in the present study. 21) Excessive alcohol consumption or known drug abuse. 22) Scheduled in patient surgery or hospitalisation during the course of the study. 23) Female patients: currently pregnant or breast-feeding or intending to become pregnant within 1 month after last dose of IP.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate safety and tolerability of DPK-060 2% ear drops compared to placebo for DPK 060 ear drops in patients with acute EO.;Secondary Objective: 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.;Primary end point(s): The primary objective is to evaluate safety and tolerability of DPK-060 2% ear drops compared to placebo for DPK 060 ear drops in patients with acute EO.;Timepoint(s) of evaluation of this end point: The primary endpoint will be evaluated after 7 or 10 days of treatment (as applicable), and at 4 weeks after the last dose of IP. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: The secondary endpoints will be assessed as follows: 1) Clinical cure at Day 8 and Day 11 2) Microbiological growth (bacteria) at Day 8 and Day 11 compared to baseline (Day 1) 3) Microbiological growth (fungi) at Day 8 and Day 11 compared to baseline (Day 1) 4) Ear pain on Day 8 and Day 11 compared to baseline (Day 1) 5) Use of rescue medication during the treatment period 6) Relapse rate within 4 weeks after last dose ;Secondary end point(s): 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. | — |
Countries
Sweden
Contacts
Public ContactJan Alenfall
Pergamum AB
Outcome results
None listed