N/A
N=216
A Study to Describe Pain Intensity, Pain Relief and Safety of Neosaldina in the Treatment of Tension-type Headaches (TTH) in Healthy Participants
Healthy Volunteers · Tension-type Headache
Bottom Line
View on ClinicalTrials.gov: NCT03666858 ↗Enrolled (actual)
216
Serious AEs
0.0%
Results posted
Jun 2021
Primary outcome: Primary: Cohort 2: Time-weighted Sum of Pain Intensity Difference From Baseline (0 Hour) to 2 Hours (SPID 0-2) Post-dose — -210 units on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Takeda
- Primary completion
- Jul 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cohort 2: Time-weighted Sum of Pain Intensity Difference From Baseline (0 Hour) to 2 Hours (SPID 0-2) Post-dose |
-210 | — |
| SECONDARY Cohorts 1 and 2: Percentage of Participants Who Achieved a Reduction of at Least 1 Point Pain in Intensity for Each Time Interval |
43.42; 45.65; 27.63; 28.26; 11.18; 10.87 | — |
| SECONDARY Cohorts 1 and 2: Time to Achieve 50 Percent (%) of Pain Intensity Reduction |
45.36; 51.36 | — |
| SECONDARY Cohorts 1 and 2: Time to First Perceptible Pain Relief (PR) |
30.31; 31.11 | — |
| SECONDARY Cohort 1: Mean Duration of PR for Participants With Second Neosaldina Intake |
5.16 | — |
| SECONDARY Cohorts 1 and 2: Number of Participants Categorized Based on Treatment Satisfaction According to Patient Global Assessments of Overall Satisfaction |
91; 63; 99; 59; 6; 5 | — |
| SECONDARY Cohorts 1 and 2: Number of Participants Categorized Based on Treatment Satisfaction According to Physician Global Assessments of Overall Satisfaction |
94; 62; 98; 62; 8; 3 | — |
| SECONDARY Cohort 1: Number of Participants Who Experienced at Least One Adverse Event (AE) After Neosaldina Administration |
6 | — |
Summary
The purpose of this study is to describe pain relief in TTH with Neosaldina treatment.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
- 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.
Data sourced from ClinicalTrials.gov (NCT03666858). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.