Drug Use Investigation for AMERGE (Naratriptan Hydrochloride) Tablet

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01376193
First received: June 9, 2011
Last updated: May 16, 2013
Last verified: May 2013
  Purpose

The study is designed to investigate the information on safety and efficacy of naratriptan tablets on Japanese subjects with migraine headache during Japanese post-marketing surveillance period.


Condition Intervention
Migraine Disorders
Drug: Naratriptan

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Drug Use Investigation for AMERGE (Naratriptan Hydrochloride) Tablet

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • The number of incidence of adverse events in subjects with migraine headache [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Occurrence of cardiovascular-related adverse events [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
    Occurrence of cardiovascular-related adverse events is investigated throughout study period

  • Occurrence of cerebrovascular disorder [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
    Occurrence of cerebrovascular disorder is investigated throughout study period

  • Occurrence of serotonin syndrome [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
    Occurrence of serotonin syndrome is investigated throughout study period


Enrollment: 500
Study Start Date: April 2009
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Subjects prescribed naratriptan tablets
Subjects with migraine headache prescribed naratriptan tablets during study period
Drug: Naratriptan
Collection of safety data

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Japanese subjects with migraine headache

Criteria

Inclusion Criteria:

  • Subjects with migraine headache
  • Must use naratriptan tablets for the first time

Exclusion Criteria:

  • Subjects with hypersensitivity to naratriptan
  • Subjects with history, symptoms, or signs of myocardial infarction, ischemic cardiac disease, or variant angina
  • Subjects with history of peripheral vascular disorder
  • Subjects with history of cerebrovascular disorder or transient ischemic attacks
  • Subjects with uncontrolled high-blood pressure
  • Subjects with severe hepatic function disorder or renal function disorder
  • Subjects taking ergotamine, ergotamine derivative containing product, or 5-HT1B/1D agonist
  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: NCT01376193

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01376193     History of Changes
Other Study ID Numbers: 112924
Study First Received: June 9, 2011
Last Updated: May 16, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Naratriptan
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014