Efficacy and Safety of a Fixed-dose Combination of Naratriptan and Naproxen in Acute Treatment of Migraine

NCT01390324 | Withdrawn Phase 3

• 1 other identifier: ACH-NRP-03(05/11)
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine whether a fixed-dose combination of naratriptan + naproxen is effective compared each monotherapy for the acute treatment of migraine.

Conditions

Migraine; Headache

Keywords

Migraine; Naratriptan; Naproxen

Outcome Measures

Primary Outcomes (1)

• Headache relief 2 hours after dosing, without use of rescue medication.

  Participants were evaluated (self-assessment) for pain intensity by using a 4-point rating scale: 0=none, 1=mild, 2=moderate, and 3=severe.

  2 hours after single dose of double-blind treatment

Secondary Outcomes (8)

• Headache relief 4 hours after dosing, without use of rescue medication

  4 hours after single dose of double-blind treatment

• Sustained headache relief over 24 hours, without use of rescue medication

  24 hours after single dose of double-blind treatment

• Pain-free response 2 and 4 hours after dosing, without use of rescue medication

  2 and 4 hours after single dose of double-blind treatment

• Sustained pain-free response over 24 hours, without use of rescue medication

  24 hours after single dose of double-blind treatment

• Freedom from photophobia, phonophobia and nausea 2 and 4 hours after dosing, without use of rescue medication

  2 and 4 hours after single dose of double-blind treatment

Study Arms (3)

Fixed-dose combination of naratriptan+naproxen

EXPERIMENTAL

Fixed-dose combination of naratriptan+naproxen

Drug: Fixed-dose combination of naratriptan+naproxen

Naratriptan

ACTIVE COMPARATOR

Naratriptan

Drug: Naratriptan

Naproxen

ACTIVE COMPARATOR

Naproxen

Drug: Naproxen

Interventions

Fixed-dose combination of naratriptan+naproxen DRUG

Tablets containing naratriptan 2,5 mg + naproxen 500 mg

Fixed-dose combination of naratriptan+naproxen

Naratriptan DRUG

Tablets containing naratriptan 2,5 mg

Naratriptan

Naproxen DRUG

Tablets containing naproxen 500 mg

Naproxen

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patient, age in the range of 18-65 years inclusive that has onset of migraine before age 50;
• Patient has at least a 3-month history of migraine with or without aura according to the ICHD-II, 2004, IHS (International Headache Society) criteria;
• Patients experienced an average migraine headache frequency of 2-6 moderate or severe attacks per month in the last 03 months prior to screening visit;
• Patients able to distinguish his/her migraine attacks from any other types of headaches;
• Patients able to understand and consent to participate in this clinical study, expressed by signing the Informed Consent (IC).

You may not qualify if:

• History of more than 6 migraine attacks/month in the last 03 months prior to screening visit;
• History of non-migraine headache frequency ≥ 15 days/month in each of the 3 months prior to screening.
• History of following migraine variants, according to the ICHD-II, 2004, IHS (International Headache Society): basilar migraine, aura without headache, familial hemiplegic migraine, sporadic hemiplegic migraine or aura with non-migraine headache;
• If female of childbearing potential, has a negative urine pregnancy test at Visit 0 and uses, or agrees to use, for the duration of the study, a medically acceptable form of contraception as determined by the investigator;
• Woman in pregnancy or lactation period;
• History of epilepsy or psychiatric condition that may affect the compliance of the treatment;
• Patients in acupuncture treatment for the symptoms of migraine attacks;
• Suffers from cardiovascular disease (ischemic heart disease, including angina pectoris, myocardial infarction, documented silent ischemia, or with Prinzmetal's angina) or has symptoms of ischemic heart disease;
• History of cerebrovascular pathology including stroke and/or transient ischemic attacks;
• History of allergic reactions to naproxen preparations, including subjects in whom aspirin or other NSAID drugs induce the syndrome of asthma, rhinitis, nasal polyps or urticaria;
• Diagnosis of renal or hepatic failure;
• Has significant (as determined by the investigator) cardiovascular risk factors that may include uncontrolled high blood pressure, post-menopausal women, males over 40 years old, hypercholesterolemia, obesity, diabetes mellitus, smoking, or a family history of cardiovascular disease in a 1st degree relative.
• Patients who have stopped or changed the dosage of the preventive treatment of migraine in the last 2 weeks prior the screening visit (V0), including the use of calcium channel blockers, tricyclic antidepressants, beta blockers or serotonergic medications for any other indications;
• Use of prohibited medicine as shown in 9.3 item of this protocol;
• Inability to understand and report the categorical scale debilitating functional of study or symptoms diary;

Sponsors & Collaborators

• Ache Laboratorios Farmaceuticos S.A.: lead

MeSH Terms

Conditions

Migraine Disorders; Headache

Interventions

naratriptan; Naproxen

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Deusvenir S Carvalho

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2011
• First Posted: July 11, 2011
• Study Start: December 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: October 19, 2016

Record last verified: 2016-10