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 |
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DOI | https://doi.org/10.1186/ISRCTN84220089 |
Secondary identifying numbers | P02.216 |
- 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
Scientific
Leiden University Medical Center
Albinusdreef 2
Leiden
2333 ZA
Netherlands
Study information
Study design | Phase I/II, double-blind, parallel-assignment, safety/efficacy, randomized placebo-controlled trial. |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Not Specified |
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 | 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 study start date | 01/03/2004 |
Completion date | 01/04/2008 |
Eligibility
Participant type(s) | Patient |
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Age group | Not Specified |
Sex | Not Specified |
Target number of participants | Part I: 16 patients; Part II: 52, with an interim analysis after 26 patients. |
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
2333 ZA
Netherlands
Sponsor information
OctoPlus N.V. (The Netherlands)
Industry
Industry
c/o Dr Ewoud-Jan van Hoogdalem
Zernikedreef 12
Leiden
2333 CL
Netherlands
Website | http://www.octoplus.nl/index.cfm/site/OctoPlus/pageid/821DEDEC-E30E-0D4E-CC80F8CDD400753F/index.cfm |
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https://ror.org/01dn4wg45 |
Funders
Funder type
Industry
OctoPlus Inc. (The Netherlands)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |