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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01332383
First received: April 7, 2011
Last updated: June 30, 2014
Last verified: June 2014
  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 ]

Enrollment: 300
Study Start Date: May 2009
Study Completion Date: October 2013
Primary Completion Date: October 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, symptoms, 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
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: 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: June 30, 2014
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

ClinicalTrials.gov processed this record on October 01, 2014