An interventional, randomized, double-blind, placebo-controlled, parallel-assignment, safety/efficacy study for treatment of chronic middle ear infection in adult patients with the antimicrobial peptide OP-145

ISRCTN	ISRCTN84220089
DOI	https://doi.org/10.1186/ISRCTN84220089
Protocol serial number	P02.216
Sponsor	OctoPlus N.V. (The Netherlands)
Funder	OctoPlus Inc. (The Netherlands)

Submission date: 24/09/2007
Registration date: 18/01/2008
Last edited: 18/01/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Ear, Nose and Throat

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Nanno F.A.W. Peek
Scientific

Leiden University Medical Center
Albinusdreef 2
Leiden
2333 ZA
Netherlands

Study information

Primary study design	Interventional
Study design	Phase I/II, double-blind, parallel-assignment, safety/efficacy, randomized placebo-controlled trial.
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	OP-145
Study objectives	The purpose of this study is to determine the safety, tolerability, and efficacy of OP-145 eardrops to the middle ear of patients with chronic otitis media. We hypothesize that OP-145 will improve the middle ear mucosa in patients with chronic otitis media.
Ethics approval(s)	Medical Ethics Committee of the Leiden University Medical Center. Approved on the 19th December 2003 (Ref: P02.216/YR/yr)
Health condition(s) or problem(s) studied	Chronic otitis media
Intervention	Part I dose finding study: The participants were allocated into four trial arms in the order of inclusion timepoints i.e. the first four participants were allocated to the lowest dose group, second four in the next dose group, etc. Arm 1: 0.25 mg/ml OP-145 eardrops twice a day Arm 2: 0.5 mg/ml OP-145 eardrops twice a day Arm 3: 1.0 mg/ml OP-145 eardrops twice a day Arm 4: 2.0 mg/ml OP-145 eardrops twice a day Duration of intervention: 2 weeks Part II randomised controlled study: Based on the results of the Part I study the Part II study was executed with 0.5 mg/ml OP-145 eardops twice a day (control: placebo twice a day) for 2 weeks.
Intervention type	Other
Primary outcome measure(s)	Safety of OP-145 eardrops, which will be determined by the following at baseline and week 1, 2, 4, 8, and 12 (for both Part I and II of the trial): 1. Hearing levels 2. Blood analysis 3. Antibody detection 4. Bacterial culture of ear and throat swabs 5. Quality of life questionnaires (the 36-item Short Form health survey (SF-36), the Brief Illness Perception Questionnaire and the Chronic Ear Survey)
Key secondary outcome measure(s)	Efficacy of OP-145 eardrops, assessed by the following at baseline and week 1, 2, 4, 8, and 12: 1. Mucosal endoscopic scores (for both Part I and II of the trial) 2. Quality of life questionnaires (the 36-item Short Form health survey (SF-36), the Brief Illness Perception Questionnaire and the Chronic Ear Survey) (only for Part II of the trial)
Completion date	01/04/2008

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Key inclusion criteria	Inclusion criteria for the Part I dose finding study: 1. Adults >= 18 years, males and females 2. Legally competent, no psychiatric history 3. Chronic otitis media with a clear perforation of the tympanic membrane >3 months 4. Chronic proliferative mucosal changes (confirmed by Computerised Tomography (CT) scan) 5. Antibiotic therapy resistant (Adequately treated with at least 2 different eardrops for >6 weeks) Inclusion criteria for the Part II randomised controlled study: 1. Adults, both males and females, over 18 years of age 2. Legally competent, with no history of psychiatric disorders 3. Chronic otitis media with a clear perforation of the tympanic membrane, lasting longer than 6 months 4. Chronic proliferative mucosal changes (confirmed with CT scan) 5. Antibiotic therapy resistant (Adequately treated with at least 2 different eardrops for >6 weeks)
Key exclusion criteria	Exclusion criteria for the Part I dose finding study: 1. Presence of cholesteatoma in the treated ear (confirmed with CT-scan) 2. History of mastoidectomy in the treated ear (resulting in a 'radicaalholte') 3. Pregnant and breastfeeding women 4. Patients that have been using topical, oral or parenteral antibiotics or steroids in the last 30 days 5. Patients that have been using prednison or any other immunosuppressive agent in the last 30 days 6. Patients with serious headaches 7. Patients with Down syndrome or other congenital anomalies in the upper respiratory tract 8. Immunocompromized patients or patients with auto-immune disorders 9. History of seizures 10. Patients with deficits at the nervus facialis Exclusion criteria for the Part II randomised controlled study: 1. Presence of cholesteatoma in the treated ear (confirmed with CT-scan) 2. History of mastoidectomy in the treated ear (resulting in a 'radicaalholte') 3. Pregnant and breastfeeding women 4. Patients that have been using topical, oral or parenteral antibiotics or steroids in the last 30 days 5. Patients that have been using prednison or any other immunosuppressive agent in the last 30 days 6. Patients with serious headaches 7. Patients with Down syndrome or other congenital anomalies in the upper respiratory tract 8. Immunocompromized patients or patients with auto-immune disorders 9. History of seizures 10. Patients with deficits at the nervus facialis 11. Patients who were included in the Part I dose finding study
Date of first enrolment	01/03/2004
Date of final enrolment	01/04/2008

Locations

Countries of recruitment

Netherlands

Study participating centre

Leiden University Medical Center

Leiden
2333 ZA
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan