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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03666858
Recruitment Status : Completed
First Posted : September 12, 2018
Last Update Posted : September 6, 2019
Sponsor:
Information provided by (Responsible Party):
Takeda

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

Condition or disease
Healthy Volunteers Tension-type Headache

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.

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Study Type : Observational
Actual Enrollment : 317 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : December 20, 2018
Actual Primary Completion Date : July 5, 2019
Actual Study Completion Date : August 19, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

Group/Cohort
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.



Primary Outcome Measures :
  1. Time-weighted sum of Pain Intensity Difference From 0 to 2 Hours Post-dose (SPID 0-2) [ Time Frame: 0 (Baseline) up to 2 hours post-dose ]
    Sum of pain intensity difference (SPID) will be calculated as time-weighted sum of the visual analogue scale (VAS) differences over 2 hour period. Pain intensity will be measured by VAS which is an 11-point numerical rating scale, ranging from 0 (no pain) to 10 (very intense pain). Pain intensity difference (PID) is the difference between baseline pain intensity (prior to the dosing) and current pain intensity at assessment. Total score ranges from -60 (worst) to 60 (best) for SPID 0-2. A higher value in SPID indicates greater pain relief.


Secondary Outcome Measures :
  1. Percentage of Participants who Achieved a Reduction of at Least 1 Point in Intensity for Each Time Interval [ Time Frame: 0 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hour, and 2 hour. ]
    Pain intensity will be measured by VAS which is an 11-point numerical rating scale, ranging from 0 (no pain) to 10 (very intense pain).

  2. Time to Achieve 50 Percent (%) of Pain Intensity Reduction [ Time Frame: Each episodic TTH (Day 1 up to Day 45) ]
    Pain intensity will be measured by VAS which is an 11-point numerical rating scale, ranging from 0 (no pain) to 10 (very intense pain).

  3. Time to First Perceptible Pain Relief (PR) [ Time Frame: Each episodic TTH (Day 1 up to Day 45) ]
    The relief of pain intensity will be assessed by the percentage pain intensity difference (PID%) in each time point. Pain intensity will be measured by VAS which is an 11-point numerical rating scale, ranging from 0 (no pain) to 10 (very intense pain). PID is the difference between baseline pain intensity (prior to the dosing) and current pain intensity at assessment.

  4. Duration of PR [ Time Frame: Each episodic TTH (Day 1 up to Day 45) ]
    Duration of PR is defined by the time of second intake of study medication.

  5. Number of Participants With Patient Global Assessments of Overall Satisfaction [ Time Frame: Day 45 ]
    Overall satisfaction of participants will be assessed by the participants based on Patient Global Assessment measured on a 5-point scale for TTH as: 0 (very satisfied); 1 (satisfied); 2 (neither satisfied nor dissatisfied); 3 (dissatisfied); 4 (very dissatisfied).

  6. Number of Participants With Physician Global Assessments of Overall Satisfaction [ Time Frame: Day 45 ]
    Overall satisfaction of participants will be assessed by the physicians based on Physician Global Assessment measured on a 5-point scale for TTH as: 0 (very satisfied); 1 (satisfied); 2 (neither satisfied nor dissatisfied); 3 (dissatisfied); 4 (very dissatisfied).

  7. Number of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE) [ Time Frame: Day 1 up to Day 45 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy adult participants with episodic TTH.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03666858


Locations
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Brazil
Fundacao do ABC
Santo Andre, SP, Brazil, 09060-870
Universidade Metropolitana de Santos
Santos, SP, Brazil, 11035-050
Cemec Centro Multidisciplinar de Estudos Clinicos Ltda-Epp
Sao Bernardo do Campo, SP, Brazil, 09715-090
Sociedade Brasileira e Japonesa de Beneficencia Santa Cruz
Sao Paulo, SP, Brazil, 04122-000
Cepic- Centro Paulista de Investigacao Clinica E Servicos Medicos Ltda
Sao Paulo, SP, Brazil, 04266-010
Sponsors and Collaborators
Takeda
Investigators
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Study Director: Medical Director Takeda
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Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT03666858    
Other Study ID Numbers: Neosaldina-5001
U1111-1218-2357 ( Registry Identifier: WHO )
First Posted: September 12, 2018    Key Record Dates
Last Update Posted: September 6, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach 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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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Takeda:
Drug Therapy
Additional relevant MeSH terms:
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Tension-Type Headache
Headache
Pain
Neurologic Manifestations
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases