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

Completed

• Conditions: Chronic otitis media; Ear, Nose and Throat

• Registration Number: ISRCTN84220089
• Lead Sponsor: OctoPlus N.V. (The Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01-18
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 0

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)

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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): <br>1. Hearing levels<br>2. Blood analysis<br>3. Antibody detection<br>4. Bacterial culture of ear and throat swabs<br>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

Name	Time	Method
Efficacy of OP-145 eardrops, assessed by the following at baseline and week 1, 2, 4, 8, and 12: <br>1. Mucosal endoscopic scores (for both Part I and II of the trial)<br>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)