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Completed

NCT Number: NCT03666858

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

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

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Key information

Conditions

Healthy Volunteers Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Nervous System Diseases Tension-Type Headache

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fundacao do ABC, Santo André, São Paulo, Brazil

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Confirmed diagnosis of episodic TTH, as determined by the International Classification of Headache Disorders.
  • Healthy participants who was prescribed 2 tablets of Neosaldina for episodic TTH.
  • Receive treatment according to the Summary of Product Characteristics for Neosaldina.
  • Has access to a mobile phone with the ability to download the app with the study questionnaire.
  • Has at least 1 episode of TTH per month.

Exclusion criteria

  • Currently participates or plans to participate in an interventional clinical trial.
  • Has hypersensitivity or intolerance to dypirone (or pyrazolonic derivatives) or other components of the product formula.
  • Has history of migraine, cluster headaches, chronic TTH or any other type of primary headache other than episodic TTH.
  • Has suspected secondary headache.
  • 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.
  • Women who may be pregnant or breastfeeding during the course of the study.
  • Has history of alcohol abuse or other drugs according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5).
  • Has mental incapacity, unwillingness or language barriers unable to understand the guidelines specified in this protocol.
  • Any other reason that, in the Investigator's opinion, makes the participant unsuitable to participate in this study.

Treatment and study plan

Primary outcomes

  1. Cohort 2: Time-weighted Sum of Pain Intensity Difference From Baseline (0 Hour) to 2 Hours (SPID 0-2) Post-dose

    Time frame: Baseline (0 hour) up to 2 hours 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.

Secondary outcomes

  1. Cohorts 1 and 2: Percentage of Participants 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

    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.

  2. Cohorts 1 and 2: Time to Achieve 50 Percent (%) of Pain Intensity Reduction

    Time frame: Each episodic TTH (Day 1 up to Day 45)

    Pain intensity was measured by VAS which was an 11-point numerical rating scale, ranging from 0 (no pain) to 10 (very intense pain).

  3. Cohorts 1 and 2: Time to First Perceptible Pain Relief (PR)

    Time frame: Each episodic TTH (Day 1 to Day 45)

    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.

  4. Cohort 1: Mean Duration of PR for Participants With Second Neosaldina Intake

    Time frame: Each episodic TTH (Day 1 up to Day 45)

    Duration of PR was defined by the time of second intake of study medication.

  5. Cohorts 1 and 2: Number of Participants Categorized Based on Treatment Satisfaction According to Patient Global Assessments of Overall Satisfaction

    Time frame: Day 45

    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).

  6. Cohorts 1 and 2: Number of Participants Categorized Based on Treatment Satisfaction According to Physician Global Assessments of Overall Satisfaction

    Time frame: Day 45

    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).

  7. Cohort 1: Number of Participants Who Experienced at Least One Adverse Event (AE) After Neosaldina Administration

    Time frame: Day 1 up to Day 45

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 12, 2018
Registry last updated
Jun 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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