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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers; Tension-type Headache

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 216

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Santo Andre, SP, Brazil, 09060-870
      • Fundacao do ABC
    • Santos, SP, Brazil, 11035-050
      • Universidade Metropolitana De Santos
    • Sao Bernardo do Campo, SP, Brazil, 09715-090
      • Cemec Centro Multidisciplinar de Estudos Clinicos Ltda-Epp
    • Sao Paulo, SP, Brazil, 04122-000
      • Sociedade Brasileira e Japonesa de Beneficencia Santa Cruz
    • Sao Paulo, SP, Brazil, 04266-010
      • Cepic- Centro Paulista de Investigacao Clinica E Servicos Medicos Ltda

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Healthy adult participants with episodic TTH.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Neosaldina; Participants with episodic TTH and who have already been treated with Neosaldina will be included in the observation period of this study. During the observation period, participants will be administered with Neosaldina 2 tablets, orally in the beginning of the TTH episode, every 6 hours, and at maximum of 8 tablets per day, according to regular clinical practice of the physicians. The participants will be observed in this study from Day 1 until Day 45.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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)
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)
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)
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
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
Cohort 1: Number of Participants Who Experienced at Least One Adverse Event (AE) After Neosaldina Administration		Day 1 up to Day 45

Collaborators and Investigators

• Sponsor: Takeda

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2018
• Primary Completion (Actual): July 5, 2019
• Study Completion (Actual): August 19, 2019

Study Registration Dates

• First Submitted: September 10, 2018
• First Submitted That Met QC Criteria: September 10, 2018
• First Posted (Actual): September 12, 2018

Study Record Updates

• Last Update Posted (Actual): June 2, 2021
• Last Update Submitted That Met QC Criteria: May 7, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Drug Therapy
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Headache Disorders, Primary; Headache Disorders; Headache; Pain; Tension-Type Headache
• Other Study ID Numbers: Neosaldina-5001; U1111-1218-2357 (Registry Identifier: WHO)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No