Unique ID issued by UMIN | UMIN000047917 |
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Receipt number | R000054626 |
Scientific Title | Prospective Study of the Efficacy, Safety and Identification of Predictors of Gefapixant for Refractory Chronic Cough |
Date of disclosure of the study information | 2022/06/01 |
Last modified on | 2022/06/01 18:28:38 |
Prospective Study of the Efficacy, Safety and Identification of Predictors of Gefapixant for Refractory Chronic Cough
J-LUNG
Prospective Study of the Efficacy, Safety and Identification of Predictors of Gefapixant for Refractory Chronic Cough
J-LUNG
Japan |
Refractory Chronic Cough
Medicine in general | Pneumology | Infectious disease |
Others
NO
Prospective Study of the Efficacy, Safety and Identification of Predictors of Gefapixant for Refractory Chronic Cough
Safety,Efficacy
Percentage of patients with an increase of at least 1.3 points in LCQ (Leicester cough questionnaire) score at 12 weeks after gefapixant administration
1. To compare the improvement of LCQ score and cough VAS (visual analogue scale) by dividing the patients into two groups based on the median values of various predictors of efficacy before administration.
2. To examine the relationship between the amount of change in each index and improvement in LCQ score and cough VAS.
3. To examine the time course of various effect predictors.
4. Change from baseline in LCQ score and cough VAS score.
Effects of drug dose reduction. 6.
6. To examine the incidence of Grade 1 or higher adverse events during treatment. 7.
7. If the same drug is continued after 12 weeks, control adverse events and cough control up to 1 year after the start of treatment with the same drug will be taken as far as possible (e.g., at 24 weeks, 52 weeks, etc.).
Observational
20 | years-old | <= |
Not applicable |
Male and Female
1. Cough persists for more than 4 months despite clinical evaluation suggesting a causative disease (GERD, asthma, upper respiratory cough syndrome, etc.) that may be associated with cough and despite appropriate diagnostic testing and treatment based on the Japanese Respiratory Society (JRS) guidelines for cough Patients with cough for more than 4 months despite appropriate diagnostic tests and treatment based on the JRS guidelines
2. Patients whose cough clinical evaluation based on the JRS guideline has revealed no relevant causative disease.
3. Patients who give written consent to participate in this study
4. Patients who are 20 years of age or older
1. Patients with a history of previous administration of gefapixant
2. Patients with serious complications such as cardiac, hepatic, or renal disease
3. Pregnant patients
4. Other patients who are judged to be unsuitable by the physician's judgment.
50
1st name | Takehiro |
Middle name | |
Last name | Izumo |
Japanese Red Cross Medical Center
Department of Respiratory Medicine
1508935
4-1-22, Hiroo Shibuya-ku, Tokyo, Japan
0334001311
drtake1118@gmail.com
1st name | Takehiro |
Middle name | |
Last name | Izumo |
Japanese Red Cross Medical Center
Department of Respiratory Medicine
1508935
4-1-22, Hiroo Shibuya-ku, Tokyo, Japan
0334001311
izumo_takehiro@med.jrc.or.jp
Japanese Red Cross Medical Center
none
Self funding
Japanese Red Cross Medical Center
4-1-22, Hiroo Shibuya-ku, Tokyo, Japan
0334001311
izumo_takehiro@med.jrc.or.jp
NO
2022 | Year | 06 | Month | 01 | Day |
Unpublished
Open public recruiting
2022 | Year | 05 | Month | 19 | Day |
2022 | Year | 05 | Month | 26 | Day |
2022 | Year | 06 | Month | 01 | Day |
2026 | Year | 12 | Month | 31 | Day |
objective study
2022 | Year | 06 | Month | 01 | Day |
2022 | Year | 06 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054626
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