Condition category
Ear, Nose and Throat
Date applied
24/09/2007
Date assigned
18/01/2008
Last edited
18/01/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Nanno F.A.W. Peek

ORCID ID

Contact details

Leiden University Medical Center
Albinusdreef 2
Leiden
2333 ZA
Netherlands

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 measures

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

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes