Efficacy and Safety of a Fixed-dose Combination of Naratriptan and Naproxen in Acute Treatment of Migraine. (Copérnico)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 2013 by Ache Laboratorios Farmaceuticos S.A.
Sponsor:
Information provided by (Responsible Party):
Ache Laboratorios Farmaceuticos S.A.
ClinicalTrials.gov Identifier:
NCT01726920
First received: November 12, 2012
Last updated: December 16, 2013
Last verified: December 2013
  Purpose

The purpose of this study is to determine whether a fixed-dose combination of naratriptan 2,5 mg + naproxen 500 mg is effective and safe compared each monotherapy for the acute treatment of migraine.


Condition Intervention Phase
Migraine
Headache
Drug: naratriptan + naproxen
Drug: naratriptan
Drug: naproxen
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III, Multicenter, National, Open, Randomized, Parallel and Comparative Study to Evaluate the Efficacy and Safety of a Fixed-dose Combination of Naratriptan 2,5 mg + Naproxen 500 mg for the Acute Treatment of Migraine.

Resource links provided by NLM:


Further study details as provided by Ache Laboratorios Farmaceuticos S.A.:

Primary Outcome Measures:
  • Headache relief 2 hours after dosing, without use of rescue medication [ Time Frame: 2 hours after single dose treatment ] [ Designated as safety issue: No ]
    Participants were evaluated (self-assessment) for pain intensity by using a 4-point rating scale: 0= none, 1= mild, 2= moderate, and 3= severe.


Secondary Outcome Measures:
  • Headache relief 4 hours after dosing, without use of rescue medication [ Time Frame: 4 hours after single dose treatment ] [ Designated as safety issue: No ]
    Participants were evaluated (self-assessment) for pain intensity by using a 4-point rating scale: 0= none, 1= mild, 2= moderate, and 3= severe

  • Maintenance of pain relief between 2 and 24 hours after dosing, without use of rescue medication [ Time Frame: 2 to 24 hours after single dose treatment ] [ Designated as safety issue: No ]
    Participants were evaluated (self-assessment) for pain intensity by using a 4-point rating scale: 0=none, 1=mild, 2=moderate, and 3=severe.

  • Pain-free response 2 and 4 hours after dosing, without use of rescue medication [ Time Frame: 2 and 4 hours after single dose treatment ] [ Designated as safety issue: No ]
    Participants were evaluated (self-assessment) for pain intensity by using a 4-point rating scale: 0= none, 1= mild, 2= moderate, and 3= severe.

  • Maintenance of pain-free response between 2 and 24 hours, without use of rescue medication [ Time Frame: 2 to 24 hours after single dose treatment ] [ Designated as safety issue: No ]
    Participants were evaluated (self-assessment) for pain intensity by using a 4-point rating scale: 0= none, 1= mild, 2= moderate, and 3= severe.

  • Freedom from nausea, vomiting, photophobia and phonophobia 2 and 4 hours after dosing [ Time Frame: 2 and 4 hours after single dose treatment ] [ Designated as safety issue: No ]
    Participants were evaluated (self-assessment) for the presence of vomiting, nausea, photophobia and phonophobia.

  • Maintenance of freedom from nausea, vomiting, photophobia and phonophobia between 2 and 24 hours after dosing, without use of rescue medication [ Time Frame: 2 to 24 hours after single dose treatment ] [ Designated as safety issue: No ]
    Participants were evaluated (self-assessment) for the presence of vomiting, nausea, photophobia and phonophobia.

  • Recurrence of pain between 2 and 24 hours after dosing, without use of rescue medication [ Time Frame: 2 to 24 hours after single dose treatment ] [ Designated as safety issue: No ]
    Participants were evaluated (self-assessment) for pain intensity by using a 4-point rating scale: 0= none, 1= mild, 2= moderate, and 3= severe.

  • Proportion of subjects who used rescue medication between 2 and 24 hours after dosing, at least once [ Time Frame: 2 to 24 hours after single dose treatment ] [ Designated as safety issue: No ]
    Participants were evaluated (self-assessment) about use of rescue medication.

  • Safety descriptive about occurence of adverse events, evaluation of results of general physical examination. [ Time Frame: Collection of safety data throughout the whole study period ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 564
Study Start Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: naratriptan + naproxen
Fixed-dose combination of naratriptan + naproxen
Drug: naratriptan + naproxen
Tablets containing naratriptan 2,5 mg + naproxen 500 mg
Active Comparator: naratriptan Drug: naratriptan
Tablets containing naratriptan 2,5 mg
Active Comparator: naproxen Drug: naproxen
Tablets containing naproxen 500 mg

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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 doesn't use, or doesn't agree 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;
  • History or symptoms of cardiovascular disease (myocardial infarction, ischemic heart disease, or with Prinzmetal's angina) or has symptoms of ischemic heart disease;
  • Suffers from peripheral vascular 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;
  • Has abused, in the opinion of the Investigator, any of the following drugs, currently or within the past 2 years: opioids, alcohol, barbiturates, benzodiazepine, cocaine or abuse of drugs for migraine treatment including narcotics or ergotamines headache in the past 03 months;
  • Hypersensitivity to naratriptan, naproxen, or any of its components;
  • Hypersensitivity to sulfonamides;
  • History of malignancy ≤ 5 years or > 5 years without documentation of remission / cure, for example, melanoma, leukemia, lymphoma, myeloproliferative disorders and renal cell carcinoma of any duration. Exception: Subjects with basal cell skin cancers, squamous cell, and cervical cancer in situ may be eligible;
  • Participation in last one year of clinical protocols, unless it can be direct benefit to patient;
  • Any finding of clinical observation (anamnesis and physical exam) laboratory abnormality (eg, blood glucose, blood count), disease (for example, liver, cardiovascular system, lung) or therapy that, in opinion of the investigator, may endanger the patient or interfere with the endpoints of study.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01726920

Contacts
Contact: Carla Peron +55 11 2608-8680 carla.peron@ache.com.br

Sponsors and Collaborators
Ache Laboratorios Farmaceuticos S.A.
  More Information

No publications provided

Responsible Party: Ache Laboratorios Farmaceuticos S.A.
ClinicalTrials.gov Identifier: NCT01726920     History of Changes
Other Study ID Numbers: ACH-NRP-03(04/12)
Study First Received: November 12, 2012
Last Updated: December 16, 2013
Health Authority: Brazil: National Health Surveillance Agency
Brazil: Ethics Committee

Keywords provided by Ache Laboratorios Farmaceuticos S.A.:
Migraine
Naratriptan
Naproxen

Additional relevant MeSH terms:
Headache
Migraine Disorders
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Naproxen
Naratriptan
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents
Vasoconstrictor Agents
Cardiovascular Agents
Serotonin 5-HT1 Receptor Agonists

ClinicalTrials.gov processed this record on July 31, 2014