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

Takeda

Status: Completed

Conditions: Healthy Volunteers; Tension-type Headache

Study type: Observational

Funder types: Industry

Identifiers

NCT03666858

Neosaldina-5001

U1111-1218-2357 (Registry Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 216 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

216 participants in 1 patient group

Neosaldina

Description:

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.