| Primary | Cohort 2: Time-weighted Sum of Pain Intensity Difference From Baseline (0 Hour) to 2 Hours (SPID 0-2) Post-dose | Sum of pain intensity difference (SPID) was calculated as time-weighted sum of the visual analogue scale (VAS) differences over 2 hour period. Pain intensity was measured by VAS which was an 11-point numerical rating scale, ranging from 0 (no pain) to 10 (very intense pain). Pain intensity difference (PID) was the difference between baseline pain intensity (prior to the dosing) and current pain intensity at assessment. Total possible score ranges from -720 (worst) to 120 (best) for SPID 0-2. A higher value in SPID indicated greater pain relief. This outcome was recorded at 15-minutes intervals for the first 60 minutes, followed by 30 minutes from 1 to 2 hours after Neosaldina administration. | All participants from Cohort 1 with TTH who reported at least one headache episode and Neosaldina intake in the mobile phone application during the study and who reported pain intensity at 0 and 120 minutes after Neosaldina intake or reported 0 pain before 120 minutes in their first headache report, and with primary endpoint data available. | Posted | | Median | Full Range | units on a scale | | Baseline (0 hour) up to 2 hours post-dose | | | | ID | Title | Description |
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| OG000 | Cohort 2 (Participants From Cohort 1): Neosaldina | All participants from Cohort 1 who reported pain intensity at 0 and 120 minutes after Neosaldina intake or reported 0 pain before 120 minutes in their first headache report and who were prescribed with 2 tablets of Neosaldina, orally, at maximum of 8 tablets per day for episodic TTH as per regular clinical practice were enrolled in this observational study on Day 1. Participants were instructed to insert the data in an application, downloaded onto mobile phone, whenever they had an episode of TTH and use Neosaldina. Participants were observed from Day 1 until Day 45. Data were also collected from medical charts and during the routine clinical appointment. |
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| Secondary | Cohorts 1 and 2: Percentage of Participants Who Achieved a Reduction of at Least 1 Point Pain in Intensity for Each Time Interval | Pain intensity was measured by VAS which was an 11-point numerical rating scale, ranging from 0 (no pain) to 10 (very intense pain). Percentage of participants are reported who had no pain relief and who achieved a reduction of at least 1 point pain in intensity for each time interval. | All participants in Cohort(C)1 with TTH who had >=1 headache/Neosaldina intake in mobile application, from C1 in C2 who had pain intensity at 0, 120 minutes after Neosaldina intake,0 pain before 120 minutes in first headache report, with primary endpoint data. Here "overall number of participants" analyzed are those who were evaluable for this outcome measure. | Posted | | Number | | percentage of participants | | 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, and 120 minutes | | | | ID | Title | Description |
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| OG000 | Cohort 1 (All Participants): Neosaldina | All healthy participants with at least one TTH episode and who were prescribed with 2 tablets of Neosaldina, orally, at maximum of 8 tablets per day for episodic TTH as per regular clinical practice were enrolled in this observational study on Day 1. Participants were instructed to insert the data in an application, downloaded onto mobile phone, whenever they had an episode of TTH and use Neosaldina. Participants were observed from Day 1 until Day 45. Data were also collected from medical charts and during the routine clinical appointment. | | OG001 | Cohort 2 (Participants From Cohort 1): Neosaldina |
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| Secondary | Cohorts 1 and 2: Time to Achieve 50 Percent (%) of Pain Intensity Reduction | Pain intensity was measured by VAS which was an 11-point numerical rating scale, ranging from 0 (no pain) to 10 (very intense pain). | All participants in Cohort (C) 1 with TTH who had >=1 headache/Neosaldina intake in mobile application and from C1 in C2 who had pain intensity at 0, 120 minutes after Neosaldina intake/0 pain before 120 minutes in first headache report, and with primary endpoint data. Overall number analyzed are those who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | minutes | | Each episodic TTH (Day 1 up to Day 45) | | | | ID | Title | Description |
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| OG000 | Cohort 1 (All Participants): Neosaldina | All healthy participants with at least one TTH episode and who were prescribed with 2 tablets of Neosaldina, orally, at maximum of 8 tablets per day for episodic TTH as per regular clinical practice were enrolled in this observational study on Day 1. Participants were instructed to insert the data in an application, downloaded onto mobile phone, whenever they had an episode of TTH and use Neosaldina. Participants were observed from Day 1 until Day 45. Data were also collected from medical charts and during the routine clinical appointment. | | OG001 | Cohort 2 (Participants From Cohort 1): Neosaldina | All participants from Cohort 1 who reported pain intensity at 0 and 120 minutes after Neosaldina intake or reported 0 pain before 120 minutes in their first headache report and who were prescribed with 2 tablets of Neosaldina, orally, at maximum of 8 tablets per day for episodic TTH as per regular clinical practice were enrolled in this observational study on Day 1. Participants were instructed to insert the data in an application, downloaded onto mobile phone, whenever they had an episode of TTH and use Neosaldina. Participants were observed from Day 1 until Day 45. Data were also collected from medical charts and during the routine clinical appointment. |
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| Secondary | Cohorts 1 and 2: Time to First Perceptible Pain Relief (PR) | The relief of pain intensity was assessed by the PID% in each time point. Pain intensity was measured by VAS which was an 11-point numerical rating scale, ranging from 0 (no pain) to 10 (very intense pain). PID was the difference between baseline pain intensity (prior to the dosing) and current pain intensity at assessment. Participants evaluated the time to first perceptible relief (confirmed by meaningful relief which was reduction of at least 1 point on pain intensity) according to the pain intensity reported at the time points 0, 15, 30, 45, 60, 90 and 120 minutes after Neosaldina administration. | All participants in Cohort (C) 1 with TTH who had >=1 headache/Neosaldina intake in mobile application and from C1 in C2 who had pain intensity at 0, 120 minutes after Neosaldina intake/0 pain before 120 minutes in first headache report, and with primary endpoint data. Overall number analyzed are those who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | minutes | | Each episodic TTH (Day 1 to Day 45) | | | | ID | Title | Description |
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| OG000 | Cohort 1 (All Participants): Neosaldina | All healthy participants with at least one TTH episode and who were prescribed with 2 tablets of Neosaldina, orally, at maximum of 8 tablets per day for episodic TTH as per regular clinical practice were enrolled in this observational study on Day 1. Participants were instructed to insert the data in an application, downloaded onto mobile phone, whenever they had an episode of TTH and use Neosaldina. Participants were observed from Day 1 until Day 45. Data were also collected from medical charts and during the routine clinical appointment. |
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| Secondary | Cohort 1: Mean Duration of PR for Participants With Second Neosaldina Intake | Duration of PR was defined by the time of second intake of study medication. | All participants with TTH who reported at least one headache episode and Neosaldina intake in the mobile phone application during the study. Here "overall number of participants" analyzed were those who had more than one headache in the same day and were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | hours | | Each episodic TTH (Day 1 up to Day 45) | | | | ID | Title | Description |
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| OG000 | Cohort 1 (All Participants): Neosaldina | All healthy participants with at least one TTH episode and who were prescribed with 2 tablets of Neosaldina, orally, at maximum of 8 tablets per day for episodic TTH as per regular clinical practice were enrolled in this observational study on Day 1. Participants were instructed to insert the data in an application, downloaded onto mobile phone, whenever they had an episode of TTH and use Neosaldina. Participants were observed from Day 1 until Day 45. Data were also collected from medical charts and during the routine clinical appointment. |
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| Secondary | Cohorts 1 and 2: Number of Participants Categorized Based on Treatment Satisfaction According to Patient Global Assessments of Overall Satisfaction | Overall satisfaction of participants was assessed by the participants based on Patient Global Assessment measured on a 5-point scale for TTH as: 0 (very satisfied); 1 (satisfied); 2 (indifferent); 3 (dissatisfied); 4 (very dissatisfied). | All participants in Cohort (C) 1 with TTH who had greater than or equal to (>=1) headache/Neosaldina intake in mobile application and from C1 in C2 who had pain intensity at 0, 120 minutes after Neosaldina intake/0 pain before 120 minutes in first headache report, and with primary endpoint data. | Posted | | Count of Participants | | Participants | | Day 45 | | | | ID | Title | Description |
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| OG000 | Cohort 1 (All Participants): Neosaldina | All healthy participants with at least one TTH episode and who were prescribed with 2 tablets of Neosaldina, orally, at maximum of 8 tablets per day for episodic TTH as per regular clinical practice were enrolled in this observational study on Day 1. Participants were instructed to insert the data in an application, downloaded onto mobile phone, whenever they had an episode of TTH and use Neosaldina. Participants were observed from Day 1 until Day 45. Data were also collected from medical charts and during the routine clinical appointment. | | OG001 | Cohort 2 (Participants From Cohort 1): Neosaldina | All participants from Cohort 1 who reported pain intensity at 0 and 120 minutes after Neosaldina intake or reported 0 pain before 120 minutes in their first headache report and who were prescribed with 2 tablets of Neosaldina, orally, at maximum of 8 tablets per day for episodic TTH as per regular clinical practice were enrolled in this observational study on Day 1. Participants were instructed to insert the data in an application, downloaded onto mobile phone, whenever they had an episode of TTH and use Neosaldina. Participants were observed from Day 1 until Day 45. Data were also collected from medical charts and during the routine clinical appointment. |
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| Secondary | Cohorts 1 and 2: Number of Participants Categorized Based on Treatment Satisfaction According to Physician Global Assessments of Overall Satisfaction | Overall satisfaction of participants was assessed by the physicians based on Physician Global Assessment measured on a 5-point scale for TTH as: 0 (very satisfied); 1 (satisfied); 2 (indifferent); 3 (dissatisfied); 4 (very dissatisfied). | All participants in Cohort (C) 1 with TTH who had >=1 headache/Neosaldina intake in mobile application and from C1 in C2 who had pain intensity at 0, 120 minutes after Neosaldina intake/0 pain before 120 minutes in first headache report, and with primary endpoint data. | Posted | | Count of Participants | | Participants | | Day 45 | | | | ID | Title | Description |
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| OG000 | Cohort 1 (All Participants): Neosaldina | All healthy participants with at least one TTH episode and who were prescribed with 2 tablets of Neosaldina, orally, at maximum of 8 tablets per day for episodic TTH as per regular clinical practice were enrolled in this observational study on Day 1. Participants were instructed to insert the data in an application, downloaded onto mobile phone, whenever they had an episode of TTH and use Neosaldina. Participants were observed from Day 1 until Day 45. Data were also collected from medical charts and during the routine clinical appointment. | | OG001 | Cohort 2 (Participants From Cohort 1): Neosaldina | All participants from Cohort 1 who reported pain intensity at 0 and 120 minutes after Neosaldina intake or reported 0 pain before 120 minutes in their first headache report and who were prescribed with 2 tablets of Neosaldina, orally, at maximum of 8 tablets per day for episodic TTH as per regular clinical practice were enrolled in this observational study on Day 1. Participants were instructed to insert the data in an application, downloaded onto mobile phone, whenever they had an episode of TTH and use Neosaldina. Participants were observed from Day 1 until Day 45. Data were also collected from medical charts and during the routine clinical appointment. |
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| Secondary | Cohort 1: Number of Participants Who Experienced at Least One Adverse Event (AE) After Neosaldina Administration | | The safety analysis set included all participants with TTH who reported at least one headache episode and Neosaldina intake in the mobile phone application. | Posted | | Count of Participants | | Participants | | Day 1 up to Day 45 | | | | ID | Title | Description |
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| OG000 | Cohort 1 (All Participants): Neosaldina | All healthy participants with at least one TTH episode and who were prescribed with 2 tablets of Neosaldina, orally, at maximum of 8 tablets per day for episodic TTH as per regular clinical practice were enrolled in this observational study on Day 1. Participants were instructed to insert the data in an application, downloaded onto mobile phone, whenever they had an episode of TTH and use Neosaldina. Participants were observed from Day 1 until Day 45. Data were also collected from medical charts and during the routine clinical appointment. |
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