Evaluation of S-600918 in Adults With Refractory Chronic Cough
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| ClinicalTrials.gov Identifier: NCT04110054 |
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Recruitment Status :
Completed
First Posted : October 1, 2019
Last Update Posted : December 10, 2021
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Sponsor:
Shionogi
Information provided by (Responsible Party):
Shionogi Inc. ( Shionogi )
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Brief Summary:
The primary objective of this study is to determine the optimal dose of S-600918 in patients with refractory chronic cough by evaluating the change from baseline in 24-hour cough frequency (coughs per hour) with S-600918 compared with placebo.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Chronic Cough | Drug: S-600918 Drug: Placebo to S-600918 | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 406 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-selection Study of S-600918 in Patients With Refractory Chronic Cough |
| Actual Study Start Date : | February 13, 2020 |
| Actual Primary Completion Date : | December 8, 2020 |
| Actual Study Completion Date : | December 28, 2020 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: S-600918 50 mg
Participants will receive 50 mg S-600918 orally once a day for 28 days.
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Drug: S-600918
Tablets for oral administration
Other Name: Sivopixant |
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Experimental: S-600918 150 mg
Participants will receive 150 mg S-600918 orally once a day for 28 days.
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Drug: S-600918
Tablets for oral administration
Other Name: Sivopixant |
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Experimental: S-600918 300 mg
Participants will receive 300 mg S-600918 orally once a day for 28 days.
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Drug: S-600918
Tablets for oral administration
Other Name: Sivopixant |
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Placebo Comparator: Placebo
Participants will receive placebo to S-600918 orally once a day for 28 days.
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Drug: Placebo to S-600918
Tablets for oral administration |
Primary Outcome Measures :
- Change in Cough at Week 4 Calculated as the Ratio of Number of Coughs per Hour in 24 Hours at Week 4 to Baseline [ Time Frame: Baseline and Week 4 ]The number of coughs per hour for 24 hours will be measured using a cough monitor.
Secondary Outcome Measures :
- Percentage of Participants with a Reduction from Baseline in the Number of Coughs per Hour in 24 Hours by ≥ 30% [ Time Frame: Baseline and Week 4 ]The number of coughs per hour for 24 hours will be measured using a cough monitor.
- Percentage of Participants with a Reduction from Baseline in the Number of Coughs per Hour in 24 Hours by ≥ 50% [ Time Frame: Baseline and Week 4 ]The number of coughs per hour for 24 hours will be measured using a cough monitor.
- Percentage of Participants with a Reduction from Baseline in the Number of Coughs per Hour in 24 Hours by ≥ 70% [ Time Frame: Baseline and Week 4 ]The number of coughs per hour for 24 hours will be measured using a cough monitor.
- Change in Cough at Week 4 Calculated as the Ratio of the Number of Coughs per Hour While Awake at Week 4 to Baseline [ Time Frame: Baseline and Week 4 ]The number of coughs per hour while awake will be measured using a cough monitor.
- Percentage of Participants with a Reduction from Baseline in the Number of Coughs per Hour While Awake by ≥ 30% [ Time Frame: Baseline and Week 4 ]The number of coughs per hour while awake will be measured using a cough monitor.
- Percentage of Participants with a Reduction from Baseline in the Number of Coughs per Hour While Awake by ≥ 50% [ Time Frame: Baseline and Week 4 ]The number of coughs per hour while awake will be measured using a cough monitor.
- Percentage of Participants with a Reduction from Baseline in the Number of Coughs per Hour While Awake by ≥ 70% [ Time Frame: Baseline and Week 4 ]The number of coughs per hour while awake will be measured using a cough monitor.
- Change in Cough at Week 4 Calculated as the Ratio of the Number of Coughs per Hour While Asleep at Week 4 to Baseline [ Time Frame: Baseline and Week 4 ]The number of coughs per hour while asleep will be measured using a cough monitor.
- Change from Baseline in Weekly Cough Severity [ Time Frame: Baseline and Week 4 ]Cough severity will be assessed by the participant on a 100 mm visual analog scale where higher scores indicate worse severity.
- Change from Baseline through Day 7 in Daily Cough Severity [ Time Frame: Baseline and Day 7 ]Cough severity will be assessed by the participant on a 100 mm visual analog scale where higher scores indicate worse severity.
- Change from Baseline in Leicester Cough Questionnaire (LCQ) [ Time Frame: Baseline and Week 4 ]The LCQ is a patient-reported quality of life (QOL) measure of chronic cough. The questionnaire consists of 19 items to which the patient responds on a 7-point Likert response scale (from 1 to 7). Each item assesses symptoms during cough and the effect of cough on 3 main domains: physical, psychological and social. Domain scores range from 1-7, and the total score ranges from 3 - 21; a higher score indicates a better quality of life.
- Percentage of Participants with an Increase in LCQ of ≥ 1.3 points [ Time Frame: Baseline and Week 4 ]The LCQ is a patient-reported quality of life (QOL) measure of chronic cough. The questionnaire consists of 19 items to which the patient responds on a 7-point Likert response scale (from 1 to 7). Each item assesses symptoms during cough and the effect of cough on 3 main domains: physical, psychological and social. Domain scores range from 1-7, and the total score ranges from 3 - 21; a higher score indicates a better quality of life.
- Change from Baseline in International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) [ Time Frame: Baseline and Week 4 ]The ICIQ-SF is a patient-reported measure of the severity of urinary incontinence and quality of life (QOL) for those with urinary incontinence. The questionnaire consists of 4 items that evaluate the frequency, severity, and impact of urinary incontinence on QOL. A total score ranging from 0-21 is possible for 3 of the 4 items combined, where a higher score indicates more severe symptoms. The 1 item remaining is not given a score; rather, the patient selects one description out of 8 possible descriptions of this item.
- Change from Baseline in Short Form (36) Health Survey (SF-36) [ Time Frame: Baseline and Week 4 ]The SF-36 is a patient-reported measure of overall health status. The questionnaire consists of 8 scaled scores (health concepts) and evaluates vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Scores for each scale range from 0 to 100; the lower the score, the greater the disability.
- Patient Global Impression of Change (PGIC) [ Time Frame: Week 4 ]The PGIC is a patient-reported measure of overall health status and consists of one item adapted from the Clinical Global Impressions scale. The patient selects one description out of 7 possible descriptions of this item. The descriptions are numbered from 1 through 7, where the most favorable description is numbered as 1 and the least favorable description is numbered as 7.
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| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Key Inclusion Criteria:
- Having refractory chronic cough (including unexplained chronic cough) for at least 1 year.
- If female and of childbearing potential, agreement to use one of the allowed contraceptive methods.
- Capable of giving signed informed consent.
Key Exclusion Criteria:
- Currently smokes or uses potentially irritating inhalational agents (eg, e-cigarettes, smokeless cigarettes, vaping); stopped smoking or using potentially irritating inhalational agents within the last year; or has a smoking history of 20 pack-years or more.
- Has chronic obstructive pulmonary disease or uncontrolled asthma.
- Has a clinically unstable medical condition.
- History of or ongoing significant psychiatric disorder.
- History of respiratory tract infection or significant change in lung function or a pulmonary condition in the last 4 weeks.
- History of malignancy in the last 5 years.
- History of severe drug allergy.
- History of alcohol or drug abuse in the last year or currently uses any form of marijuana or illicit drugs.
- Has a clinically significant finding on a chest x-ray or chest computed tomography (CT) scan in the last year.
- Has systolic blood pressure > 160 mm Hg or diastolic blood pressure > 90 mm Hg.
- Received S-600918 previously.
- Received an investigational drug in the last 3 months.
- Received an angiotensin converting enzyme (ACE) inhibitor in the last 3 months or requires such treatment.
- Has a positive serologic test for human immunodeficiency virus (HIV) antigen or antibody, hepatitis B virus surface antigen, or hepatitis C virus ribonucleic acid (RNA).
- If female, pregnant or trying to become pregnant or breastfeeding.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04110054
Locations
Show 136 study locations
Sponsors and Collaborators
Shionogi
Investigators
| Study Director: | Shionogi Clinical Trials Administrator Clinical Support Help Line | Shionogi |
| Responsible Party: | Shionogi |
| ClinicalTrials.gov Identifier: | NCT04110054 |
| Other Study ID Numbers: |
1812VA323 |
| First Posted: | October 1, 2019 Key Record Dates |
| Last Update Posted: | December 10, 2021 |
| Last Verified: | December 2021 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Shionogi Inc. ( Shionogi ):
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P2X3 receptor antagonist Refractory chronic cough S-600918 |
Additional relevant MeSH terms:
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Cough Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory |