Clinical Trials Register

Summary
EudraCT Number:	2011-001407-13
Sponsor's Protocol Code Number:	NL35847.068.11
National Competent Authority:	Netherlands - Competent Authority
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2011-04-27
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Netherlands - Competent Authority

A.2

EudraCT number

2011-001407-13

A.3

Full title of the trial

NasuMel® Gel - a Medical Grade Honey Product for the Treatment of Chronically Infected Radical Mastoid Cavities

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

NasuMel®, een medisch honing product voor de behandeling van een chronisch ontstoken radicaal holte

A.3.2

Name or abbreviated title of the trial where available

NasuMel® Gel - Treatment of Radical Mastoid Cavities

A.4.1

Sponsor's protocol code number

NL35847.068.11

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Maastricht Universitary Medical Centre
B.1.3.4	Country	Netherlands
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Bfactory
B.4.2	Country	Netherlands
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Academisch ziekenhuis Maastricht
B.5.2	Functional name of contact point	Keel Neus Oorheelkunde
B.5.3	Address:
B.5.3.1	Street Address	P. Debyelaan 25
B.5.3.2	Town/ city	Maastricht
B.5.3.3	Post code	6229 HX
B.5.3.4	Country	Netherlands
B.5.4	Telephone number	00310433876543
B.5.5	Fax number	00310433875580
B.5.6	E-mail	nasumel@me.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	NasuMel
D.2.1.1.2	Name of the Marketing Authorisation holder	Bfactory
D.2.1.2	Country which granted the Marketing Authorisation	Netherlands
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	NasuMel
D.3.4	Pharmaceutical form	Ear gel
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Auricular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	purfied honey
D.3.9.1	CAS number	8028-66-8
D.3.9.3	Other descriptive name	HONEY
D.3.9.4	EV Substance Code	SUB14116MIG
D.3.10	Strength
D.3.10.1	Concentration unit	ml millilitre(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	3 to 5
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	Yes
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Ear drops
D.8.4	Route of administration of the placebo	Auricular use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Chronically infected radical mastoidectomy cavity

E.1.1.1

Medical condition in easily understood language

Chronical infection of a cavity in the ear after an operation, where parts of the middle ear and the mastoid bone are removed

E.1.1.2

Therapeutic area

Diseases [C] - Ear, nose and throat diseases [C09]

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The primary objective of the study is the evaluation of the therapeutic benefit of
two repeated cavity injections of NasuMel® Neusgel in comparison to the management
with local antibiotic/corticosteroid droplets in the treatment of chronically infected/discharging
radical mastoid cavities.

E.2.2

Secondary objectives of the trial

The secondary objectives of the study are (a) eradication of cavity infection by NasuMel®,
(b) patient and doctors satisfaction and (c) histologically enhancement of the cavity after the
treatment.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

a.Previous operation or reoperation of the middle ear and mastoid bone with the creation of a radical mastoid cavity.
b.Presentation with symptoms of an infected/discharging cavity (otorrhea (defined as actual discharge, feeling of discharge by the patient, recent detection of signs of discharge by the patient on pillow or clothes), signs of infection during otologic exploration) on the first visit in association with the study.
c.No other invasive otologic operations after the introduction of the radical cavity (this does not include reoperations).
d.Age between 18 – 80 years.

E.4

Principal exclusion criteria

a.Not fulfilling inclusion criteria.
b.Any other actual “experimental” treatment for mastoid cavity infection/discharge.
c.Abscess or infection processes in the mastoid/temporal bone or structures directly adjacent to the radical cavity.
d.Chronic intake (cumulative > 5 days) of non-steroidal anti-inflammatory drugs, corticosteroids (systemic or in open cavities, not defined as control treatment) or other medications interfering with the immune system or with a systemic antimicrobial effect (e.g. antibiotics, not defined as control treatment).
e.Known allergic reaction to honey.
f.Minors and/or incapacitated adults.

E.5 End points

E.5.1

Primary end point(s)

Number of hospital contacts (time to event) during twelve weeks for infection/discharge of patients with continuous or intermittent infected/discharging radical mastoid cavities treated with NasuMel® or local antibiotics + corticosteroids.

E.5.1.1

Timepoint(s) of evaluation of this end point

After 12 weeks after start of the study.

E.5.2

Secondary end point(s)

a.Mean and median time to first symptom presentation after initial treatment (first contact after initial treatment with hospital for otologic problems, correlated to the radical cavity).
b.Individual patient evaluation of symptoms during the study period. This is defined as difference in VAS score, which are scored on every visit by the patient (4 in total).
c.Individual patient evaluation of symptom enhancement after the study period by the VAS. On visit 4 (8 weeks after last treatment) the patient fills in a transitional VAS, as “overall” difference.
d.Evaluation of symptom change during the study period by a physician by an approved grading system for infection control in otology (Merchnant et al.33). This score is given at every patient’s visit (4 times in total).
e.Eradication of bacteria (pre- and post-study swab, at visit 1 and 3).
f.Histo-pathological characteristics of actively infected/discharging radical mastoid cavities compared to symptom free post-treatment cavities (descriptive). At visit 1 and 3.
g.Histological samples of the intervention and control group will be compared by three different histological grading scales. At visit 1 and 3.
h.Amount of additional medication for problems that are related to otologic diseases.

E.5.2.1

Timepoint(s) of evaluation of this end point

After 4, 8 and 12 weeks after start of the study.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

Yes

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

Yes

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Terra-Cortril + Polymyxine B (oxytetracycline/ hydrocortisone /polymyxin B)

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1