Clinical trial NCT03666858: A Study to Describe Pain Intensity, Pain Relief and Safety of Neosaldina in the Treatment of Tension-type Headaches (TTH) in Healthy Participants
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Volunteers
Tension-type Headache
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2018-09-12
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy adult participants with episodic TTH.

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cohort 2: Time-weighted Sum of Pain Intensity Difference From Baseline (0 Hour) to 2 Hours (SPID 0-2) Post-dose
timeFrame: Baseline (0 hour) up to 2 hours post-dose
Secondary outcomes:
measure: Cohorts 1 and 2: Percentage of Participants Who Achieved a Reduction of at Least 1 Point Pain in Intensity for Each Time Interval
timeFrame: 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, and 120 minutes
measure: Cohorts 1 and 2: Time to Achieve 50 Percent (%) of Pain Intensity Reduction
timeFrame: Each episodic TTH (Day 1 up to Day 45)
measure: Cohorts 1 and 2: Time to First Perceptible Pain Relief (PR)
timeFrame: Each episodic TTH (Day 1 to Day 45)
measure: Cohort 1: Mean Duration of PR for Participants With Second Neosaldina Intake
timeFrame: Each episodic TTH (Day 1 up to Day 45)
measure: Cohorts 1 and 2: Number of Participants Categorized Based on Treatment Satisfaction According to Patient Global Assessments of Overall Satisfaction
timeFrame: Day 45
measure: Cohorts 1 and 2: Number of Participants Categorized Based on Treatment Satisfaction According to Physician Global Assessments of Overall Satisfaction
timeFrame: Day 45
measure: Cohort 1: Number of Participants Who Experienced at Least One Adverse Event (AE) After Neosaldina Administration
timeFrame: Day 1 up to Day 45
Other outcomes:
Locations:
city: Santo Andre
country: Brazil
facility: Fundacao do ABC
state: SP
city: Santos
country: Brazil
facility: Universidade Metropolitana de Santos
state: SP
city: Sao Bernardo do Campo
country: Brazil
facility: Cemec Centro Multidisciplinar de Estudos Clinicos Ltda-Epp
state: SP
city: Sao Paulo
country: Brazil
facility: Sociedade Brasileira e Japonesa de Beneficencia Santa Cruz
state: SP
city: Sao Paulo
country: Brazil
facility: Cepic- Centro Paulista de Investigacao Clinica E Servicos Medicos Ltda
state: SP
Study officials:
affiliation: Takeda
name: Medical Director
role: STUDY_DIRECTOR
References: