UMIN-CTR Clinical Trial

Public title

Efficacy of combined effect of
Carbocisteine in chronic sinusitis
patients taking Clarithromycin

Acronym

GETS Study

Scientific Title

Efficacy of combined effect of
Carbocisteine in chronic sinusitis
patients taking Clarithromycin

Scientific Title:Acronym

GETS Study

Region

Japan

Condition

Chronic Sinusitis

Classification by specialty

Oto-rhino-laryngology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To weigh the differences of clinical effect between carbocisteine 1500mg/day-
clarithromycin 200mg/day against
clarithromycin 200mg/day

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Clinical effect (after 12 weeks)

Key secondary outcomes

1. SNOT-20 improvement factor
2. CT scoring
3. Clinical effect(4 weeks, 8 weeks later)
4. Subjective symptoms
5. Objective symptoms

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Carbocisteine & Clarithromycin

Interventions/Control_2

Clarithromycin

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Patients with symptoms which had persisted for more than 12 weeks, such as nasal congestion, rhinorrhea, postnasal drip and coughing
2. Patients who were found to have paranasal sinus shadowing upon simple X-ray or CT conducted after the patient displayed one or more
of the symptoms in 1.
3. Patients who had at least one subjective symptom (nasal
discharge, rhinorrhea, postnasal
drip, nasal congestion, heaviness of head (headache), dysosmia) and at least one objective symptom (nasal mucosal redness, nasal mucosal swelling, nasal discharge, postnasal drip) at the baseline.
4. Patients with nasal polyp of score 0 or 1 in severity
5. Outpatients
6. Patients 20 years old or above when submitting informed consent
7. Patients with the ability to
understand the QOL question items
8. Patients giving written informed consent

Key exclusion criteria

1. Patients who cannot tolerate
carbocisteine or clarithromycin
2. Patients who received airway
disease drugs (e.g. mucolytic agents) or 14-membered macrolides within 2 weeks prior to the start of the study
3. Patients who at the start of the study were scheduled to later receive anti-inflammatory enzyme, steroids (oral, inhalation, injection, nasal spray), anti-allergic agents, or
Chinese herbal medicine
4. Patients participating in other studies at the start of this study
5. Patients who have undergone
radical sinus surgery
6. Patients who have undergone endoscopic sinus surgery within 12 weeks prior to the start of the study
7. Patients who have or are suspected to have paranasal mycosis
8. Patients with complications of bronchial asthma
9.Patients with history of severe cardiovascular disease
10. Patients with a complication of malignant tumor
11.Women who are or may be pregnant
12.Patients considered inappropriate by the physicians in charge

Target sample size

500

Name of lead principal investigator

1st name
Middle name
Last name	Yuichi Majima

Organization

Ise Municipal General Hospital

Division name

Department of Otorhinolaryngology

Zip code

Address

3038 kusube-cho, Ise-shi, Mie, 516-0014 Japan

TEL

0596-23-5111

Email

Name of contact person

1st name
Middle name
Last name	Michiaki Ota

Organization

Kyorin Pharmaceutical Co.,LTD

Division name

P.L.C. Management Department

Zip code

Address

5, Kanda Surugadai 2-chome,

TEL

03-3293-3422

Homepage URL

Email

michiaki.oota@mb.kyorin-pharm.co.jp

Institute

GETS Study Group

Institute

Department

Personal name

Organization

Kyorin Pharmaceutical Co.,LTD

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2009

Year

09

Month

24

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2008

Year

03

Month

25

Day

Date of IRB

Anticipated trial start date

2008

Year

05

Month

01

Day

Last follow-up date

2009

Year

09

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2009

Year

09

Month

18

Day

Last modified on

2009

Year

11

Month

24

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003084