A Study to Describe Pain Intensity, Pain Relief and Safety of Neosaldina in the Treatment of Tension-type Headaches (TTH) in Healthy Participants

Healthy Volunteers Clinical Trial

Official title:

An Observational, Single-Arm Study to Describe Pain Intensity, Pain Relief and Safety of Neosaldina in the Treatment of Tension-Type Headaches in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03666858
• Other study ID #: Neosaldina-5001
• Secondary ID: U1111-1218-2357
• Status: Completed
• Start date: December 20, 2018
• Est. completion date: August 19, 2019

Study information

• Verified date: May 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to describe pain relief in TTH with Neosaldina treatment.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 216
• Est. completion date: August 19, 2019
• Est. primary completion date: July 5, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Confirmed diagnosis of episodic TTH, as determined by the International Classification of Headache Disorders.

2. Healthy participants who was prescribed 2 tablets of Neosaldina for episodic TTH.

3. Receive treatment according to the Summary of Product Characteristics for Neosaldina.

4. Has access to a mobile phone with the ability to download the app with the study questionnaire.

5. Has at least 1 episode of TTH per month.

Exclusion Criteria:

1. Currently participates or plans to participate in an interventional clinical trial.

2. Has hypersensitivity or intolerance to dypirone (or pyrazolonic derivatives) or other components of the product formula.

3. Has history of migraine, cluster headaches, chronic TTH or any other type of primary headache other than episodic TTH.

4. Has suspected secondary headache.

5. Has serious comorbidities (hypertension, blood dyscrasias, malignant neoplasms, any type of hepatitis or kidney disease, disorders of the hematopoietic system, insufficient function of the bone marrow or certain metabolic diseases, such as hepatic porphyria or congenital deficiency of glucose-6-phosphate dehydrogenase) or taking any medications which might confound the pharmacological effects of the study drug (example immunosuppressive drugs, and beta blockers, anticonvulsivants, antidepressants) within 30 days before the start of study.

6. Women who may be pregnant or breastfeeding during the course of the study.

7. Has history of alcohol abuse or other drugs according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5).

8. Has mental incapacity, unwillingness or language barriers unable to understand the guidelines specified in this protocol.

9. Any other reason that, in the Investigator's opinion, makes the participant unsuitable to participate in this study.

Related Conditions & MeSH terms

• Headache
• Healthy Volunteers
• Pain
• Tension-type Headache

Locations

Country	Name	City	State
Brazil	Fundacao do ABC	Santo Andre	SP
Brazil	Universidade Metropolitana de Santos	Santos	SP
Brazil	Cemec Centro Multidisciplinar de Estudos Clinicos Ltda-Epp	Sao Bernardo do Campo	SP
Brazil	Cepic- Centro Paulista de Investigacao Clinica E Servicos Medicos Ltda	Sao Paulo	SP
Brazil	Sociedade Brasileira e Japonesa de Beneficencia Santa Cruz	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline (0 hour) up to 2 hours post-dose
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.	15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, and 120 minutes
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).	Each episodic TTH (Day 1 up to Day 45)
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.	Each episodic TTH (Day 1 to Day 45)
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.	Each episodic TTH (Day 1 up to Day 45)
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).	Day 45
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).	Day 45
Secondary	Cohort 1: Number of Participants Who Experienced at Least One Adverse Event (AE) After Neosaldina Administration		Day 1 up to Day 45