Special Drug Use Investigation for AMERGE Tablet (Long-term)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01332383
First received: April 7, 2011
Last updated: January 24, 2013
Last verified: January 2013
  Purpose

To investigate the long-term safety and efficacy of AMERGE (naratriptan hydrochloride) on Japanese patients with migraine headache in clinical setting


Condition Intervention
Migraine Disorders
Drug: Naratriptan

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Special Drug Use Investigation for AMERGE Tablet (Long-term)

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • The number of adverse drug reactions and serious adverse events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: May 2009
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients prescribed AMERGE
Patients with migraine disorders prescribed AMERGE during study period
Drug: Naratriptan

  Eligibility

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

Patients with migraine headache who are naive to AMERGE

Criteria

Inclusion Criteria:

  • Must use AMERGE for the first time

Exclusion Criteria:

  • Patients with hypersensitivity to naratriptan or any of the components.
  • Patients with history, symproms, or signs of myocardial infarction, ischemic cardiac or angina inversa
  • Patients with history of cerebral vascular disturbance or transient ischaemic attack
  • Patients with peripheral vascular syndromes
  • Patients with uncontrolled hypertension
  • Patients with severe renal or hepatic impairment
  • Patients using treatment with another 5-HT1 agonist, an ergotamine-containing or ergot-type medication
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01332383

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

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01332383     History of Changes
Other Study ID Numbers: 112925
Study First Received: April 7, 2011
Last Updated: January 24, 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
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 22, 2014