NCT03666858 is a clinical trial in Healthy Volunteers, sponsored by Takeda.

Who is sponsoring NCT03666858?

NCT03666858 is sponsored by Takeda.

What condition does NCT03666858 study?

NCT03666858 studies Healthy Volunteers, Tension-type Headache.

Is NCT03666858 still recruiting?

NCT03666858 is currently completed. Last updated 2 June 2021.

Are results published for NCT03666858?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-06-02 · How we verify

NCT03666858

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Results posted Last updated 2 June 2021

What this trial tests

trial in Healthy Volunteers in 216 participants. Completed in 19 August 2019.

Timeline

20 December 2018

Primary endpoint
5 July 2019

19 August 2019

Quick facts

Lead sponsor	Takeda
Status	Completed
Study type	OBSERVATIONAL
Enrollment	216
Start date	20 December 2018
Primary completion	5 July 2019
Estimated completion	19 August 2019
Sites	5 locations across Brazil

Conditions studied

Healthy Volunteers — all drugs for Healthy Volunteers →
Tension-type Headache — all drugs for Tension-type Headache →

Sponsor

Takeda — full company profile →

Who can join

18 and older, any sex, with Healthy Volunteers or Tension-type Headache. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Cohort 2: Time-weighted Sum of Pain Intensity Difference From Baseline (0 Hour) to 2 Hours (SPID 0-2) Post-dose Primary · 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

Group	Value	95% CI
Cohort 2 (Participants From Cohort 1): Neosaldina	-210	-690 – 120

Cohorts 1 and 2: Percentage of Participants Who Achieved a Reduction of at Least 1 Point Pain in Intensity for Each Time Interval Secondary · 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, and 120 minutes

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.

At 15 minutes

Group	Value	95% CI
Cohort 1 (All Participants): Neosaldina	43.42
Cohort 2 (Participants From Cohort 1): Neosaldina	45.65

At 30 minutes

Group	Value	95% CI
Cohort 1 (All Participants): Neosaldina	27.63
Cohort 2 (Participants From Cohort 1): Neosaldina	28.26

At 45 minutes

Group	Value	95% CI
Cohort 1 (All Participants): Neosaldina	11.18
Cohort 2 (Participants From Cohort 1): Neosaldina	10.87

At 60 minutes

Group	Value	95% CI
Cohort 1 (All Participants): Neosaldina	7.89
Cohort 2 (Participants From Cohort 1): Neosaldina	6.52

At 90 minutes

Group	Value	95% CI
Cohort 1 (All Participants): Neosaldina	2.63
Cohort 2 (Participants From Cohort 1): Neosaldina	5.07

At 120 minutes

Group	Value	95% CI
Cohort 1 (All Participants): Neosaldina	1.32
Cohort 2 (Participants From Cohort 1): Neosaldina	1.45

No pain relief

Group	Value	95% CI
Cohort 1 (All Participants): Neosaldina	5.92
Cohort 2 (Participants From Cohort 1): Neosaldina	2.17

Cohorts 1 and 2: Time to Achieve 50 Percent (%) of Pain Intensity Reduction Secondary · Each episodic TTH (Day 1 up to Day 45)

Pain intensity was measured by VAS which was an 11-point numerical rating scale, ranging from 0 (no pain) to 10 (very intense pain).

Group	Value	95% CI
Cohort 1 (All Participants): Neosaldina	45.36	± 26.63
Cohort 2 (Participants From Cohort 1): Neosaldina	51.36	± 31.89

Cohorts 1 and 2: Time to First Perceptible Pain Relief (PR) Secondary · Each episodic TTH (Day 1 to Day 45)

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 administ

Group	Value	95% CI
Cohort 1 (All Participants): Neosaldina	30.31	± 20.57
Cohort 2 (Participants From Cohort 1): Neosaldina	31.11	± 22.34

Cohort 1: Mean Duration of PR for Participants With Second Neosaldina Intake Secondary · Each episodic TTH (Day 1 up to Day 45)

Duration of PR was defined by the time of second intake of study medication.

Group	Value	95% CI
Cohort 1 (All Participants): Neosaldina	5.16	± 2.26

Cohorts 1 and 2: Number of Participants Categorized Based on Treatment Satisfaction According to Patient Global Assessments of Overall Satisfaction Secondary · Day 45

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).

Very satisfied

Group	Value	95% CI
Cohort 1 (All Participants): Neosaldina	91
Cohort 2 (Participants From Cohort 1): Neosaldina	63

Satisfied

Group	Value	95% CI
Cohort 1 (All Participants): Neosaldina	99
Cohort 2 (Participants From Cohort 1): Neosaldina	59

Indifferent

Group	Value	95% CI
Cohort 1 (All Participants): Neosaldina	6
Cohort 2 (Participants From Cohort 1): Neosaldina	5

Dissatisfied

Group	Value	95% CI
Cohort 1 (All Participants): Neosaldina	7
Cohort 2 (Participants From Cohort 1): Neosaldina	3

Very dissatisfied

Group	Value	95% CI
Cohort 1 (All Participants): Neosaldina	2
Cohort 2 (Participants From Cohort 1): Neosaldina	1

Unknown

Group	Value	95% CI
Cohort 1 (All Participants): Neosaldina	11
Cohort 2 (Participants From Cohort 1): Neosaldina	7

Cohorts 1 and 2: Number of Participants Categorized Based on Treatment Satisfaction According to Physician Global Assessments of Overall Satisfaction Secondary · Day 45

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).

Very satisfied

Group	Value	95% CI
Cohort 1 (All Participants): Neosaldina	94
Cohort 2 (Participants From Cohort 1): Neosaldina	62

Satisfied

Group	Value	95% CI
Cohort 1 (All Participants): Neosaldina	98
Cohort 2 (Participants From Cohort 1): Neosaldina	62

Indifferent

Group	Value	95% CI
Cohort 1 (All Participants): Neosaldina	8
Cohort 2 (Participants From Cohort 1): Neosaldina	3

Dissatisfied

Group	Value	95% CI
Cohort 1 (All Participants): Neosaldina	3
Cohort 2 (Participants From Cohort 1): Neosaldina	3

Very dissatisfied

Group	Value	95% CI
Cohort 1 (All Participants): Neosaldina	2
Cohort 2 (Participants From Cohort 1): Neosaldina	1

Unknown

Group	Value	95% CI
Cohort 1 (All Participants): Neosaldina	11
Cohort 2 (Participants From Cohort 1): Neosaldina	7

Cohort 1: Number of Participants Who Experienced at Least One Adverse Event (AE) After Neosaldina Administration Secondary · Day 1 up to Day 45

Group	Value	95% CI
Cohort 1 (All Participants): Neosaldina	6

Adverse events — posted to ClinicalTrials.gov

Time frame: Treatment-emergent adverse events are adverse events that started after Day 1 up to Day 45. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Cohort 1 (All Participants): Neosaldina

Serious: 0/216 (0%)

Deaths: 0/216

Other adverse events (5 terms — click to expand)

Reaction	System	Cohort 1 (All Participants…
Sleepiness	Nervous system disorders	—
Nausea	Gastrointestinal disorders	—
Lack of vitamin D	General disorders	—
Hypertension	Vascular disorders	—
Bacterial infection	Infections and infestations	—

Data from ClinicalTrials.gov NCT03666858 adverse events section.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03666858 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Takeda
Last refreshed: 2 June 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03666858.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing