Efficacy and Safety of Rizatriptan-Naproxen (10/550 Mg) i... | NCT04384367

Studies
Efficacy and Safety of Rizatriptan-Naproxen (10/550 Mg) in the Acute Treatment of Migraine

NCT04384367

Sponsor

Eurofarma Laboratorios S.A.

Status

Completed

Last Update Posted

Feb 14, 2025Actual

Enrollment

2,068Actual

Phase

Phase 3

Conditions

Migraine

Interventions

Rizatriptan 10 mg + Naproxen 550mg
Maxalt 10Mg Tablet
Flanax 550mg
Placebo oral tablet

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 30, 2022Actual

Primary Completion Date

Oct 30, 2024Actual

Completion Date

Nov 30, 2024Actual

First Submitted Date

Apr 6, 2020

First Submission Date that Met QC Criteria

May 11, 2020

First Posted Date

May 12, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 12, 2025

Last Update Posted Date

Feb 14, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

A phase III study, multicenter, double-blind, double-dummy, randomized, single-dose, placebo-controlled study to evaluate the efficacy and safety of Rizatriptan-Naproxen (10/550 mg) in the acute treatment of migraine.

⚠️Study will only be conducted in research centers in Brazil (please do not send e-mail if your center is outside brazil).

Detailed Description

This is a prospective, randomized, double-blind, double-dummy and placebo-controlled study in individuals with disabling migraine. The participants will be randomized to receive Rizatriptan + Naproxen (10/550mg), Rizatriptan (10mg), Naproxen (550mg) or placebo.

⚠️Study will only be conducted in research centers in Brazil (please do not send e-mail if your center is outside brazil).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

2,068Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Rizatriptan 10mg+ Naproxen 550mg	Experimental	Rizatriptan 10mg+ Naproxen 550mg	Drug: Rizatriptan 10 mg + Naproxen 550mg
Maxalt 10mg	Active Comparator	Rizatriptan10mg	Drug: Maxalt 10Mg Tablet
Flanax 550mg	Active Comparator	Naproxen 550mg	Drug: Flanax 550mg
Placebo	Placebo Comparator	Placebo	Drug: Placebo oral tablet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Rizatriptan 10 mg + Naproxen 550mg	Drug	oral - single dose	Rizatriptan 10mg+ Naproxen 550mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
2-hour pain-free	2-hour pain-free response (Proportion of participants reporting pain freedom at two hours post-dose)	11 weeks

Secondary Outcomes

Measure	Description	Time Frame
Most bothersome migraine-associated symptom	Migraine-associated symptoms: nausea, vomiting, photophobia or phonophobia and phonophobia (frequency)	11 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients of both sexes;
Aged between 18 and 65 years old;
Capable and willing to give free and informed informed consent in writing;
Migraine patients with or without aura, according to the International Headache Society (IHS).

Exclusion Criteria:

Chronic migraine;
Headache other than migraine (that is, tension-type headache, sinusitis, etc.).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Eurofarma Laboratorios S.A		São Paulo	São Paulo	06696-000	Brazil
CEPIC

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008881	Migraine Disorders

Ancestor Terms

ID	Term
D051270	Headache Disorders, Primary
D020773	Headache Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C093622	rizatriptan
D009288	Naproxen
D013607	Tablets

Ancestor Terms

ID	Term
D009280	Naphthaleneacetic Acids
D009281	Naphthalenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic

Browse Leaves

Not provided

Browse Branches

Not provided