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
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

Leiden University Medical Center
Albinusdreef 2
Leiden
2333 ZA
Netherlands

Study information

Study designPhase I/II, double-blind, parallel-assignment, safety/efficacy, randomized placebo-controlled trial.
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study acronymOP-145
Study objectivesThe 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) studiedChronic otitis media
InterventionPart 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 typeOther
Primary outcome measureSafety 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 measuresEfficacy 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 date01/03/2004
Completion date01/04/2008

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participantsPart I: 16 patients; Part II: 52, with an interim analysis after 26 patients.
Key inclusion criteriaInclusion 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 criteriaExclusion 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 enrolment01/03/2004
Date of final enrolment01/04/2008

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Leiden University Medical Center
Leiden
2333 ZA
Netherlands

Sponsor information

OctoPlus N.V. (The Netherlands)
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
ROR logo "ROR" https://ror.org/01dn4wg45

Funders

Funder type

Industry

OctoPlus Inc. (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan