| Primary | Change From Baseline to Week 12 in Awake Objective Cough Frequency | Objective cough frequency measured by ambulatory cough monitoring device | The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data). | Posted | | Mean | Standard Deviation | coughs per hour (log transformed) | | Baseline to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Orvepitant 10mg | Orvepitant 10mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral | | OG001 | Orvepitant 20mg | Orvepitant 20mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral | | OG002 | Orvepitant 30mg | Orvepitant 30mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral | | OG003 | Placebo | Placebo to match tablet, once daily for 12 weeks Placebo: Tablet, once daily, oral |
| | Units | Counts |
|---|
| Participants | - OG00066
- OG00172
- OG00267
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000-0.185± 0.3258
- OG001-0.192± 0.3405
- OG002-0.271± 0.4055
- OG003
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| Change from baseline to each visit (Week 2, Week 4 and Week 12) in log transformed awake objective cough frequency was analysed using a mixed model for repeated measures (MMRM) with restricted maximum likelihood (REML) estimation. The treatment effect at Week 12 was estimated using the ratio of geometric means (i.e. the difference between the treatments least squares means [adjusted means] on the log scale, back transformed to the original scale). | Mixed model repeated measures | | 0.324 | | Mean Difference (Final Values) | 1.14 | | | 2-Sided | 95 | 0.88 | 1.49 | | | | | Superiority | |
|
| Secondary | Change in Awake Objective Cough Frequency at Week 2 Compared to Baseline | Objective cough frequency measured by ambulatory cough monitoring device | The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data). | Posted | | Mean | Standard Deviation | coughs per hour (log transformed) | | Baseline to Week 2 | | | | ID | Title | Description |
|---|
| OG000 | Orvepitant 10mg | Orvepitant 10mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral | | OG001 | Orvepitant 20mg | Orvepitant 20mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral | | OG002 | Orvepitant 30mg | Orvepitant 30mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral | | OG003 | Placebo | Placebo to match tablet, once daily for 12 weeks Placebo: Tablet, once daily, oral |
|
| Secondary | Change in Awake Objective Cough Frequency at Week 4 Compared to Baseline | Objective cough frequency measured by ambulatory cough monitoring device | The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data). | Posted | | Mean | Standard Deviation | coughs per hour (log transformed) | | Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Orvepitant 10mg | Orvepitant 10mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral | | OG001 | Orvepitant 20mg | Orvepitant 20mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral | | OG002 | Orvepitant 30mg | Orvepitant 30mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral | | OG003 | Placebo | Placebo to match tablet, once daily for 12 weeks Placebo: Tablet, once daily, oral |
|
| Secondary | Change in the Leicester Cough Questionnaire (LCQ) at Week 2 Compared to Baseline | The Leicester Cough Questionnaire (LCQ) is a 19 item questionnaire that assessed cough related quality of life. It has three domains (physical, psychological and social) and subjects were asked to complete it based on their experience in a recall period of 2 weeks. The total score range is 3 to 21 and domain scores each range from 1 to 7; a higher score indicated a better quality of life. Subjects completed the LCQ whilst in the clinic at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12. | The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data). | Posted | | Mean | Standard Deviation | Total score | | Baseline to Week 2 | | | | ID | Title | Description |
|---|
| OG000 | Orvepitant 10mg | Orvepitant 10mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral | | OG001 | Orvepitant 20mg | Orvepitant 20mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral | | OG002 | Orvepitant 30mg | Orvepitant 30mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral |
|
| Secondary | Change in the Leicester Cough Questionnaire (LCQ) at Week 4 Compared to Baseline | The Leicester Cough Questionnaire (LCQ) is a 19 item questionnaire that assessed cough related quality of life. It has three domains (physical, psychological and social) and subjects were asked to complete it based on their experience in a recall period of 4 weeks. The total score range is 3 to 21 and domain scores each range from 1 to 7; a higher score indicated a better quality of life. Subjects completed the LCQ whilst in the clinic at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12. | The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data). | Posted | | Mean | Standard Deviation | Total score | | Baseline to Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Orvepitant 10mg | Orvepitant 10mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral | | OG001 | Orvepitant 20mg | Orvepitant 20mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral | | OG002 | Orvepitant 30mg | Orvepitant 30mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral |
|
| Secondary | Change in the Leicester Cough Questionnaire (LCQ) at Week 8 Compared to Baseline | The Leicester Cough Questionnaire (LCQ) is a 19 item questionnaire that assessed cough related quality of life. It has three domains (physical, psychological and social) and subjects were asked to complete it based on their experience in a recall period of 8 weeks. The total score range is 3 to 21 and domain scores each range from 1 to 7; a higher score indicated a better quality of life. Subjects completed the LCQ whilst in the clinic at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12. | The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data). | Posted | | Mean | Standard Deviation | Total score | | Baseline to Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Orvepitant 10mg | Orvepitant 10mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral | | OG001 | Orvepitant 20mg | Orvepitant 20mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral | | OG002 | Orvepitant 30mg | Orvepitant 30mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral |
|
| Secondary | Change in the Leicester Cough Questionnaire (LCQ) at Week 12 Compared to Baseline | The Leicester Cough Questionnaire (LCQ) is a 19 item questionnaire that assessed cough related quality of life. It has three domains (physical, psychological and social) and subjects were asked to complete it based on their experience in a recall period of 12 weeks. The total score range is 3 to 21 and domain scores each range from 1 to 7; a higher score indicated a better quality of life. Subjects completed the LCQ whilst in the clinic at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12. | The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data). | Posted | | Mean | Standard Deviation | Total score | | Baseline to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Orvepitant 10mg | Orvepitant 10mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral | | OG001 | Orvepitant 20mg | Orvepitant 20mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral | | OG002 | Orvepitant 30mg | Orvepitant 30mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral |
|
| Secondary | Change in the Cough Severity Visual Analogue Scale (VAS) at Week 2 Compared to Baseline - Day-time | The cough VAS is a 100 mm scale on which subjects indicated their severity of cough over the previous 24 hours, both during the day-time and during night time separately. The VAS ranged from "no cough" (0 mm) on the left to "worst cough" (100 mm) on the right. Subjects completed the cough severity VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12. | The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data). | Posted | | Mean | Standard Deviation | Score | | Baseline to Week 2 | | | | ID | Title | Description |
|---|
| OG000 | Orvepitant 10mg | Orvepitant 10mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral | | OG001 | Orvepitant 20mg | Orvepitant 20mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral | | OG002 | Orvepitant 30mg | Orvepitant 30mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral | | OG003 |
|
| Secondary | Change in the Cough Severity Visual Analogue Scale (VAS) at Week 4 Compared to Baseline - Day-time | The cough VAS is a 100 mm scale on which subjects indicated their severity of cough over the previous 24 hours, both during the day-time and during night time separately. The VAS ranged from "no cough" (0 mm) on the left to "worst cough" (100 mm) on the right. Subjects completed the cough severity VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12. | The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data). | Posted | | Mean | Standard Deviation | Score | | Baseline to Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Orvepitant 10mg | Orvepitant 10mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral | | OG001 | Orvepitant 20mg | Orvepitant 20mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral | | OG002 | Orvepitant 30mg | Orvepitant 30mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral | | OG003 |
|
| Secondary | Change in the Cough Severity Visual Analogue Scale (VAS) at Week 8 Compared to Baseline - Day-time | The cough VAS is a 100 mm scale on which subjects indicated their severity of cough over the previous 24 hours, both during the day-time and during night time separately. The VAS ranged from "no cough" (0 mm) on the left to "worst cough" (100 mm) on the right. Subjects completed the cough severity VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12. | The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data). | Posted | | Mean | Standard Deviation | Score | | Baseline to Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Orvepitant 10mg | Orvepitant 10mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral | | OG001 | Orvepitant 20mg | Orvepitant 20mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral | | OG002 | Orvepitant 30mg | Orvepitant 30mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral | | OG003 |
|
| Secondary | Change in the Cough Severity Visual Analogue Scale (VAS) at Week 12 Compared to Baseline - Day-time | The cough VAS is a 100 mm scale on which subjects indicated their severity of cough over the previous 24 hours, both during the day-time and during night time separately. The VAS ranged from "no cough" (0 mm) on the left to "worst cough" (100 mm) on the right. Subjects completed the cough severity VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12. | The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data). | Posted | | Mean | Standard Deviation | Score | | Baseline to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Orvepitant 10mg | Orvepitant 10mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral | | OG001 | Orvepitant 20mg | Orvepitant 20mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral | | OG002 | Orvepitant 30mg | Orvepitant 30mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral | |
|
| Secondary | Change in the Cough Severity Visual Analogue Scale (VAS) at Week 2 Compared to Baseline - Night-time | The cough VAS is a 100 mm scale on which subjects indicated their severity of cough over the previous 24 hours, both during the day-time and during night time separately. The VAS ranged from "no cough" (0 mm) on the left to "worst cough" (100 mm) on the right. Subjects completed the cough severity VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12. | The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data). | Posted | | Mean | Standard Deviation | Score | | Baseline to Week 2 | | | | ID | Title | Description |
|---|
| OG000 | Orvepitant 10mg | Orvepitant 10mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral | | OG001 | Orvepitant 20mg | Orvepitant 20mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral | | OG002 | Orvepitant 30mg | Orvepitant 30mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral | |
|
| Secondary | Change in the Cough Severity Visual Analogue Scale (VAS) at Week 4 Compared to Baseline - Night-time | The cough VAS is a 100 mm scale on which subjects indicated their severity of cough over the previous 24 hours, both during the day-time and during night time separately. The VAS ranged from "no cough" (0 mm) on the left to "worst cough" (100 mm) on the right. Subjects completed the cough severity VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12. | The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data). | Posted | | Mean | Standard Deviation | Score | | Baseline to Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Orvepitant 10mg | Orvepitant 10mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral | | OG001 | Orvepitant 20mg | Orvepitant 20mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral | | OG002 | Orvepitant 30mg | Orvepitant 30mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral | |
|
| Secondary | Change in the Cough Severity Visual Analogue Scale (VAS) at Week 8 Compared to Baseline - Night-time | The cough VAS is a 100 mm scale on which subjects indicated their severity of cough over the previous 24 hours, both during the day-time and during night time separately. The VAS ranged from "no cough" (0 mm) on the left to "worst cough" (100 mm) on the right. Subjects completed the cough severity VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12. | The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data). | Posted | | Mean | Standard Deviation | Score | | Baseline to Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Orvepitant 10mg | Orvepitant 10mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral | | OG001 | Orvepitant 20mg | Orvepitant 20mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral | | OG002 | Orvepitant 30mg | Orvepitant 30mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral | |
|
| Secondary | Change in the Cough Severity Visual Analogue Scale (VAS) at Week 12 Compared to Baseline - Night-time | The cough VAS is a 100 mm scale on which subjects indicated their severity of cough over the previous 24 hours, both during the day-time and during night time separately. The VAS ranged from "no cough" (0 mm) on the left to "worst cough" (100 mm) on the right. Subjects completed the cough severity VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12. | The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data). | Posted | | Mean | Standard Deviation | Score | | Baseline to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Orvepitant 10mg | Orvepitant 10mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral | | OG001 | Orvepitant 20mg | Orvepitant 20mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral | | OG002 | Orvepitant 30mg | Orvepitant 30mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral | |
|
| Secondary | Change in the Urge-to-cough Visual Analogue Scale (VAS) at Week 2 Compared to Baseline | The urge-to-cough VAS was a 100 mm scale on which subjects indicated their urge to cough over the previous 24 hours (day/awake time and night time combined). The VAS ranged from "no urge to cough" (0 mm) on the left to "severe urge to cough" (100 mm) on the right. Subjects completed the urge to cough VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12. | The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data). | Posted | | Mean | Standard Deviation | Score | | Baseline to Week 2 | | | | ID | Title | Description |
|---|
| OG000 | Orvepitant 10mg | Orvepitant 10mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral | | OG001 | Orvepitant 20mg | Orvepitant 20mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral | | OG002 | Orvepitant 30mg | Orvepitant 30mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral | | OG003 |
|
| Secondary | Change in the Urge-to-cough Visual Analogue Scale (VAS) at Week 4 Compared to Baseline | The urge-to-cough VAS was a 100 mm scale on which subjects indicated their urge to cough over the previous 24 hours (day/awake time and night time combined). The VAS ranged from "no urge to cough" (0 mm) on the left to "severe urge to cough" (100 mm) on the right. Subjects completed the urge to cough VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12. | The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data). | Posted | | Mean | Standard Deviation | Score | | Baseline to Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Orvepitant 10mg | Orvepitant 10mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral | | OG001 | Orvepitant 20mg | Orvepitant 20mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral | | OG002 | Orvepitant 30mg | Orvepitant 30mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral | | OG003 |
|
| Secondary | Change in the Urge-to-cough Visual Analogue Scale (VAS) at Week 8 Compared to Baseline | The urge-to-cough VAS was a 100 mm scale on which subjects indicated their urge to cough over the previous 24 hours (day/awake time and night time combined). The VAS ranged from "no urge to cough" (0 mm) on the left to "severe urge to cough" (100 mm) on the right. Subjects completed the urge to cough VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12. | The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data). | Posted | | Mean | Standard Deviation | Score | | Baseline to Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Orvepitant 10mg | Orvepitant 10mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral | | OG001 | Orvepitant 20mg | Orvepitant 20mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral | | OG002 | Orvepitant 30mg | Orvepitant 30mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral | | OG003 |
|
| Secondary | Change in the Urge-to-cough Visual Analogue Scale (VAS) at Week 12 Compared to Baseline | The urge-to-cough VAS was a 100 mm scale on which subjects indicated their urge to cough over the previous 24 hours (day/awake time and night time combined). The VAS ranged from "no urge to cough" (0 mm) on the left to "severe urge to cough" (100 mm) on the right. Subjects completed the urge to cough VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12. | The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data). | Posted | | Mean | Standard Deviation | Score | | Baseline to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Orvepitant 10mg | Orvepitant 10mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral | | OG001 | Orvepitant 20mg | Orvepitant 20mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral | | OG002 | Orvepitant 30mg | Orvepitant 30mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral | | OG003 |
|
| Secondary | Global Rating of Change in Cough Frequency at Week 2 | In the Global Rating of Change scale, subjects indicated if there had been a change in their symptoms (cough frequency and, separately, cough severity) since starting the IMP. Subjects responded with "worse", "about the same" or "better". If subjects indicated a change (either "worse" or "better") they then indicated on a 7 point scale the degree of change ranging from 1 (almost the same, hardly any change) to 7 (a very great deal changed). Subjects documented their Global Rating of Change in cough frequency and cough severity at Weeks 2, 4, 8, and 12. | The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data). | Posted | | Count of Participants | | Participants | | Baseline to Week 2 | | | | ID | Title | Description |
|---|
| OG000 | Orvepitant 10mg | Orvepitant 10mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral | | OG001 | Orvepitant 20mg | Orvepitant 20mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral | | OG002 | Orvepitant 30mg | Orvepitant 30mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral |
|
| Secondary | Global Rating of Change in Cough Frequency at Week 4 | In the Global Rating of Change scale, subjects indicated if there had been a change in their symptoms (cough frequency and, separately, cough severity) since starting the IMP. Subjects responded with "worse", "about the same" or "better". If subjects indicated a change (either "worse" or "better") they then indicated on a 7 point scale the degree of change ranging from 1 (almost the same, hardly any change) to 7 (a very great deal changed). Subjects documented their Global Rating of Change in cough frequency and cough severity at Weeks 2, 4, 8, and 12. | The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data). | Posted | | Count of Participants | | Participants | | Baseline to Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Orvepitant 10mg | Orvepitant 10mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral | | OG001 | Orvepitant 20mg | Orvepitant 20mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral | | OG002 | Orvepitant 30mg | Orvepitant 30mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral |
|
| Secondary | Global Rating of Change in Cough Frequency at Week 8 | In the Global Rating of Change scale, subjects indicated if there had been a change in their symptoms (cough frequency and, separately, cough severity) since starting the IMP. Subjects responded with "worse", "about the same" or "better". If subjects indicated a change (either "worse" or "better") they then indicated on a 7 point scale the degree of change ranging from 1 (almost the same, hardly any change) to 7 (a very great deal changed). Subjects documented their Global Rating of Change in cough frequency and cough severity at Weeks 2, 4, 8, and 12. | The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data). | Posted | | Count of Participants | | Participants | | Baseline to Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Orvepitant 10mg | Orvepitant 10mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral | | OG001 | Orvepitant 20mg | Orvepitant 20mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral | | OG002 | Orvepitant 30mg | Orvepitant 30mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral |
|
| Secondary | Global Rating of Change in Cough Frequency at Week 12 | In the Global Rating of Change scale, subjects indicated if there had been a change in their symptoms (cough frequency and, separately, cough severity) since starting the IMP. Subjects responded with "worse", "about the same" or "better". If subjects indicated a change (either "worse" or "better") they then indicated on a 7 point scale the degree of change ranging from 1 (almost the same, hardly any change) to 7 (a very great deal changed). Subjects documented their Global Rating of Change in cough frequency and cough severity at Weeks 2, 4, 8, and 12. | The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data). | Posted | | Count of Participants | | Participants | | Baseline to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Orvepitant 10mg | Orvepitant 10mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral | | OG001 | Orvepitant 20mg | Orvepitant 20mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral | | OG002 | Orvepitant 30mg | Orvepitant 30mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral |
|
| Secondary | Global Rating of Change in Cough Severity at Week 2 | In the Global Rating of Change scale, subjects indicated if there had been a change in their symptoms (cough frequency and, separately, cough severity) since starting the IMP. Subjects responded with "worse", "about the same" or "better". If subjects indicated a change (either "worse" or "better") they then indicated on a 7 point scale the degree of change ranging from 1 (almost the same, hardly any change) to 7 (a very great deal changed). Subjects documented their Global Rating of Change in cough frequency and cough severity at Weeks 2, 4, 8, and 12. | The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data). | Posted | | Count of Participants | | Participants | | Baseline to Week 2 | | | | ID | Title | Description |
|---|
| OG000 | Orvepitant 10mg | Orvepitant 10mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral | | OG001 | Orvepitant 20mg | Orvepitant 20mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral | | OG002 | Orvepitant 30mg | Orvepitant 30mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral |
|
| Secondary | Global Rating of Change in Cough Severity at Week 4 | In the Global Rating of Change scale, subjects indicated if there had been a change in their symptoms (cough frequency and, separately, cough severity) since starting the IMP. Subjects responded with "worse", "about the same" or "better". If subjects indicated a change (either "worse" or "better") they then indicated on a 7 point scale the degree of change ranging from 1 (almost the same, hardly any change) to 7 (a very great deal changed). Subjects documented their Global Rating of Change in cough frequency and cough severity at Weeks 2, 4, 8, and 12. | The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data). | Posted | | Count of Participants | | Participants | | Baseline to Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Orvepitant 10mg | Orvepitant 10mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral | | OG001 | Orvepitant 20mg | Orvepitant 20mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral | | OG002 | Orvepitant 30mg | Orvepitant 30mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral |
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| Secondary | Global Rating of Change in Cough Severity at Week 8 | In the Global Rating of Change scale, subjects indicated if there had been a change in their symptoms (cough frequency and, separately, cough severity) since starting the IMP. Subjects responded with "worse", "about the same" or "better". If subjects indicated a change (either "worse" or "better") they then indicated on a 7 point scale the degree of change ranging from 1 (almost the same, hardly any change) to 7 (a very great deal changed). Subjects documented their Global Rating of Change in cough frequency and cough severity at Weeks 2, 4, 8, and 12. | The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data). | Posted | | Count of Participants | | Participants | | Baseline to Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Orvepitant 10mg | Orvepitant 10mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral | | OG001 | Orvepitant 20mg | Orvepitant 20mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral | | OG002 | Orvepitant 30mg | Orvepitant 30mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral |
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| Secondary | Global Rating of Change in Cough Severity at Week 12 | In the Global Rating of Change scale, subjects indicated if there had been a change in their symptoms (cough frequency and, separately, cough severity) since starting the IMP. Subjects responded with "worse", "about the same" or "better". If subjects indicated a change (either "worse" or "better") they then indicated on a 7 point scale the degree of change ranging from 1 (almost the same, hardly any change) to 7 (a very great deal changed). Subjects documented their Global Rating of Change in cough frequency and cough severity at Weeks 2, 4, 8, and 12. | The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data). | Posted | | Count of Participants | | Participants | | Baseline to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Orvepitant 10mg | Orvepitant 10mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral | | OG001 | Orvepitant 20mg | Orvepitant 20mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral | | OG002 | Orvepitant 30mg | Orvepitant 30mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral |
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