UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001009
Receipt number R000001216
Scientific Title Open-label, single-center, randomized and parallel-group study to compare the efficacy of olopatadine hydrochloride and dextromethorphan hydrobromide in prolonged and chronic cough
Date of disclosure of the study information 2008/02/01
Last modified on 2010/03/30 17:12:41

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Open-label, single-center, randomized and parallel-group study to compare the efficacy of olopatadine hydrochloride and dextromethorphan hydrobromide in prolonged and chronic cough

Acronym

Study to compare the efficacy of olopatadine hydrochloride and dextromethorphan hydrobromide in prolonged and chronic cough

Scientific Title

Open-label, single-center, randomized and parallel-group study to compare the efficacy of olopatadine hydrochloride and dextromethorphan hydrobromide in prolonged and chronic cough

Scientific Title:Acronym

Study to compare the efficacy of olopatadine hydrochloride and dextromethorphan hydrobromide in prolonged and chronic cough

Region

Japan


Condition

Condition

Prolonged and chronic cough

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To compare the efficacy of olopatadine hydrochloride and dextromethorphan hydrobromide in prolonged and chronic cough by using symptom scores, VAS score, cough sensitivity test and biomarkers and neuropeptide of induced sputum and plasma.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase IV


Assessment

Primary outcomes

Symptom scores and VAS score(at 0 and 2 weeks)
Capsaicin cough sensitivity test(at 0 and 2weeks)
Concentrations of substance P in sputum and plasma(at 0 and 2weeks)

Key secondary outcomes

1. Pulmonary function tests(at 0 and 2weeks)
2. Inflammatory biomarkers of induced sputum and serum(at 0 and 2weeks)
3. Exhaled nitric oxide concentration(at 0 and 2weeks)
4. Parameters of impulse oscillometry(at 0 and 2weeks)
5. safety


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking

NO

Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

olopatadine hydrochloride
5mg b.i.d, for 2 weeks

Interventions/Control_2

dextromethorphan hydrobromide
15mg t.i.d, for 2 weeks

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Cough persisting for longer than 3 weeks.
2. No radiological evidence of chest disease.
3. Who gave written informed consent.

Key exclusion criteria

1. Patients with a history of hypersensitivity to olopatadine hydrochloride or dextromethorphan hydrobromide
2. Patients receiving monoamine oxidase inhibitor (MAOI) therapy and for 14 days after stopping MAOI therapy
3. Patients with a history of other chest disease
4. Patients taking angiotensin-converting enzyme inhibitors.
5. Patients during pregnancy or lactation
6. Inappropriate patients from the doctor's viewpoint

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Akio Niimi

Organization

Kyoto University Graduate School of Medicine

Division name

Department of Respiratory Medicine

Zip code


Address

54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, Japan.

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Kojiro Otsuka

Organization

Kyoto University Graduate School of Medicine

Division name

Department of Respiratory Medicine

Zip code


Address

54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, Japan.

TEL

075-751-3830

Homepage URL


Email



Sponsor or person

Institute

Kyoto University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2008 Year 02 Month 01 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

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



Progress

Recruitment status

Completed

Date of protocol fixation

2007 Year 12 Month 19 Day

Date of IRB


Anticipated trial start date

2008 Year 02 Month 01 Day

Last follow-up date

2010 Year 03 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2008 Year 02 Month 01 Day

Last modified on

2010 Year 03 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001216


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name