Trials / Completed
CompletedNCT03666858
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
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 216 (actual)
- Sponsor
- Takeda · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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.
Conditions
Timeline
- Start date
- 2018-12-20
- Primary completion
- 2019-07-05
- Completion
- 2019-08-19
- First posted
- 2018-09-12
- Last updated
- 2021-06-02
- Results posted
- 2021-06-02
Locations
5 sites across 1 country: Brazil
Source: ClinicalTrials.gov record NCT03666858. Inclusion in this directory is not an endorsement.