Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
P02.216
Study information
Scientific title
Acronym
OP-145
Study hypothesis
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
Medical Ethics Committee of the Leiden University Medical Center. Approved on the 19th December 2003 (Ref: P02.216/YR/yr)
Study design
Phase I/II, double-blind, parallel-assignment, safety/efficacy, randomized placebo-controlled trial.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
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
Phase
Phase I/II
Drug names
Primary outcome measure
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)
Secondary outcome measures
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)
Overall trial start date
01/03/2004
Overall trial end date
01/04/2008
Reason abandoned (if study stopped)
Eligibility
Participant 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)
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Part I: 16 patients; Part II: 52, with an interim analysis after 26 patients.
Participant 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
Recruitment start date
01/03/2004
Recruitment end date
01/04/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
Leiden University Medical Center
Leiden
2333 ZA
Netherlands
Sponsor information
Organisation
OctoPlus N.V. (The Netherlands)
Sponsor details
c/o Dr Ewoud-Jan van Hoogdalem
Zernikedreef 12
Leiden
2333 CL
Netherlands
Sponsor type
Industry
Website
http://www.octoplus.nl/index.cfm/site/OctoPlus/pageid/821DEDEC-E30E-0D4E-CC80F8CDD400753F/index.cfm
Funders
Funder type
Industry
Funder name
OctoPlus Inc. (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list