Special Drug Use Investigation for AMERGE Tablet (Long-term)
Overview[ - collapse ][ - ]
| Purpose | To investigate the long-term safety and efficacy of AMERGE (naratriptan hydrochloride) on Japanese patients with migraine headache in clinical setting |
|---|---|
| Condition | Migraine Disorders |
| Intervention | Drug: Naratriptan |
| Phase | N/A |
| Sponsor | GlaxoSmithKline |
| Responsible Party | GlaxoSmithKline |
| ClinicalTrials.gov Identifier | NCT01332383 |
| First Received | April 7, 2011 |
| Last Updated | January 24, 2013 |
| Last verified | January 2013 |
Tracking Information[ + expand ][ + ]
| First Received Date | April 7, 2011 |
|---|---|
| Last Updated Date | January 24, 2013 |
| Start Date | May 2009 |
| Estimated Primary Completion Date | February 2014 |
| Current Primary Outcome Measures | The number of adverse drug reactions and serious adverse events [Time Frame: 6 months] [Designated as safety issue: Yes] |
| Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
| Brief Title | Special Drug Use Investigation for AMERGE Tablet (Long-term) |
|---|---|
| Official Title | Special Drug Use Investigation for AMERGE Tablet (Long-term) |
| Brief Summary | To investigate the long-term safety and efficacy of AMERGE (naratriptan hydrochloride) on Japanese patients with migraine headache in clinical setting |
| Detailed Description | Not Provided |
| Study Type | Observational |
| Study Phase | N/A |
| Study Design | Time Perspective: Prospective |
| Condition | Migraine Disorders |
| Intervention | Drug: Naratriptan |
| Study Arm (s) | Patients prescribed AMERGE Patients with migraine disorders prescribed AMERGE during study period |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Active, not recruiting |
|---|---|
| Estimated Enrollment | 300 |
| Estimated Completion Date | February 2014 |
| Estimated Primary Completion Date | November 2013 |
| Eligibility 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 |
| Gender | Both |
| Ages | N/A |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Not Provided |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01332383 |
|---|---|
| Other Study ID Numbers | 112925 |
| Has Data Monitoring Committee | No |
| Information Provided By | GlaxoSmithKline |
| Study Sponsor | GlaxoSmithKline |
| Collaborators | Not Provided |
| Investigators | Study Director: GSK Clinical Trials GlaxoSmithKline |
| Verification Date | January 2013 |