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

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ClinicalTrials.gov Identifier: NCT01390324
Recruitment Status : Withdrawn
First Posted : July 11, 2011
Last Update Posted : October 19, 2016
Sponsor:
Information provided by (Responsible Party):
Ache Laboratorios Farmaceuticos S.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.

Condition or disease Intervention/treatment Phase
Migraine Headache Drug: Fixed-dose combination of naratriptan+naproxen Drug: Naratriptan Drug: Naproxen Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, National, Double-blind, Randomized Study to Evaluate the Efficacy and Safety of a Fixed-dose Combination of Naratriptan 2,5 mg + Naproxen 500 mg Relative to Efficacy and Safety of Each Monotherapy for the Acute Treatment of Migraine
Study Start Date : December 2011
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Migraine

Arm Intervention/treatment
Experimental: Fixed-dose combination of naratriptan+naproxen
Fixed-dose combination of naratriptan+naproxen
Drug: Fixed-dose combination of naratriptan+naproxen
Tablets containing naratriptan 2,5 mg + naproxen 500 mg

Active Comparator: Naratriptan
Naratriptan
Drug: Naratriptan
Tablets containing naratriptan 2,5 mg

Active Comparator: Naproxen
Naproxen
Drug: Naproxen
Tablets containing naproxen 500 mg




Primary Outcome Measures :
  1. Headache relief 2 hours after dosing, without use of rescue medication. [ Time Frame: 2 hours after single dose of double-blind treatment ]
    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 :
  1. Headache relief 4 hours after dosing, without use of rescue medication [ Time Frame: 4 hours after single dose of double-blind treatment ]
  2. Sustained headache relief over 24 hours, without use of rescue medication [ Time Frame: 24 hours after single dose of double-blind treatment ]
  3. Pain-free response 2 and 4 hours after dosing, without use of rescue medication [ Time Frame: 2 and 4 hours after single dose of double-blind treatment ]
  4. Sustained pain-free response over 24 hours, without use of rescue medication [ Time Frame: 24 hours after single dose of double-blind treatment ]
  5. Freedom from photophobia, phonophobia and nausea 2 and 4 hours after dosing, without use of rescue medication [ Time Frame: 2 and 4 hours after single dose of double-blind treatment ]
  6. Sustained freedom from photophobia, phonophobia and nausea from 2 through 24 hours after dosing, without use of rescue medication [ Time Frame: 2 through 24 hours after single dose of double-blind treatment ]
  7. Proportion of subjects who used rescue medication between 2 and 24 hours after dosing, at least once [ Time Frame: 2 and 24 hours after single dose of double-blind treatment ]
  8. 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 ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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 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;
  • 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 ergotamines headache in the past 03 months;
  • Hypersensitivity, intolerance, or contraindication to the use of naratriptan or naproxen, any of its components;
  • Hypersensitivity, intolerance, or contraindication to the use of 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01390324


Sponsors and Collaborators
Ache Laboratorios Farmaceuticos S.A.
Investigators
Principal Investigator: Deusvenir S Carvalho Federal University of São Paulo

Responsible Party: Ache Laboratorios Farmaceuticos S.A.
ClinicalTrials.gov Identifier: NCT01390324     History of Changes
Other Study ID Numbers: ACH-NRP-03(05/11)
First Posted: July 11, 2011    Key Record Dates
Last Update Posted: October 19, 2016
Last Verified: October 2016

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

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