Healthy VolunteersNCT03666858
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 study of Healthy Volunteers and Tension-type Headache, run by Takeda at 5 sites in Brazil.
Trial summary
The purpose of this study is to describe pain relief in TTH with Neosaldina treatment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Tension-type Headache
- Type of treatment
- Pill or oral medicine
- How many people
- 216 participants
- Where
- 5 sitesBrazil
- Study dates
- 20 Dec 2018to 19 Aug 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy adult participants with episodic TTH.
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Brazil5 sites
Fundacao do ABC
Santo André, São Paulo, 09060-870
Universidade Metropolitana de Santos
Santos, São Paulo, 11035-050
Cemec Centro Multidisciplinar de Estudos Clinicos Ltda-Epp
São Bernardo do Campo, São Paulo, 09715-090
Sociedade Brasileira e Japonesa de Beneficencia Santa Cruz
São Paulo, São Paulo, 04122-000
Cepic- Centro Paulista de Investigacao Clinica E Servicos Medicos Ltda
São Paulo, São Paulo, 04266-010
About this study
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
The purpose of this study is to describe pain relief in TTH with Neosaldina treatment.
Read the 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
- Healthy Volunteers, Tension-type Headache
- Keywords
- Drug Therapy
- Medical subject headings
- Tension-Type Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (0 hour) up to 2 hours post-dose
Secondary outcomes (7)
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: Day 45
Cohort 1: Number of Participants Who Experienced at Least One Adverse Event (AE) After Neosaldina Administration
Measured: Day 1 up to Day 45
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2018
- Study start20 Dec 2018
- Primary completion5 Jul 2019
- Study completion19 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03666858
- Sponsor's protocol ID
- Neosaldina-5001
- Other IDs
- U1111-1218-2357
- Status last verified
- May 2021
- First submitted
- 10 Sep 2018
- Last updated
- 2 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03666858
- Acronym / sponsor ID
- Neosaldina-5001
- Conditions
- Healthy Volunteers, Tension-type Headache
- Keywords
- Drug Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 20 Dec 2018 (actual)
- Primary completion
- 5 Jul 2019 (actual)
- Study completion
- 19 Aug 2019 (actual)
- First posted
- 12 Sep 2018 (actual)
- Results
- Posted 2 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy adult participants with episodic TTH.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
7 secondary outcomes
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
Cohorts 1 and 2: Time to Achieve 50 Percent (%) of Pain Intensity Reduction
Time frame: Each episodic TTH (Day 1 up to Day 45)
Cohorts 1 and 2: Time to First Perceptible Pain Relief (PR)
Time frame: Each episodic TTH (Day 1 to Day 45)
Cohort 1: Mean Duration of PR for Participants With Second Neosaldina Intake
Time frame: 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
Time frame: Day 45
Cohorts 1 and 2: Number of Participants Categorized Based on Treatment Satisfaction According to Physician Global Assessments of Overall Satisfaction
Time frame: Day 45
Cohort 1: Number of Participants Who Experienced at Least One Adverse Event (AE) After Neosaldina Administration
Time frame: Day 1 up to Day 45
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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.
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Takeda
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Volunteers and Tension-type Headache, run by Takeda at 5 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2021.