The purpose of this study is to describe pain relief in TTH with Neosaldina treatment.
This is an observational, non-interventional and prospective study of healthy participants with episodic TTH who have already been treated with Neosaldina according to regular clinical practice. This study will assess the pain intensity and pain relief of TTH after the uptake of Neosaldina. This study will enroll approximately 317 participants. All participants will be enrolled into one observational group: • Neosaldina Investigators will assess participants from the time of enrolment through the completion of observation period up to 6 months. Each participant will be assessed up to 45 days after first dose. The data will be collected from medical charts and during routine follow up visits. The data from participants will be collected through a self-administered questionnaire using a mobile phone. All the participants will be instructed to insert the data in an application, downloaded in their phone whenever they will have an episode of TTH and use Neosaldina. This multi-center trial will be conducted in Brazil. The overall duration of observation period in this study is approximately 6 months. Participants will be contacted by telephone on Days 15 and 30 for a follow up and will make a final visit on Day 45.
Study Type
OBSERVATIONAL
Enrollment
216
Fundacao do ABC
Santo André, São Paulo, Brazil
Universidade Metropolitana de Santos
Santos, São Paulo, Brazil
Cemec Centro Multidisciplinar de Estudos Clinicos Ltda-Epp
São Bernardo do Campo, São Paulo, Brazil
Sociedade Brasileira e Japonesa de Beneficencia Santa Cruz
São Paulo, São Paulo, Brazil
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.
Time frame: Baseline (0 hour) up to 2 hours post-dose
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.
Time frame: 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, and 120 minutes
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).
Time frame: Each episodic TTH (Day 1 up to Day 45)
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.
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Cepic- Centro Paulista de Investigacao Clinica E Servicos Medicos Ltda
São Paulo, São Paulo, Brazil
Time frame: Each episodic TTH (Day 1 to Day 45)
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.
Time frame: Each episodic TTH (Day 1 up to Day 45)
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).
Time frame: Day 45
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).
Time frame: Day 45
Cohort 1: Number of Participants Who Experienced at Least One Adverse Event (AE) After Neosaldina Administration
Time frame: Day 1 up to Day 45