Description:

Study ID: 110948 Clinical Study ID: 110948 Study Title: Assessment of the effect of sumatriptan and naproxen sodium combination tablet, sumatriptan tablet, and naproxen sodium tablet treatment on blood pressure when administered intermittently for six months for the acute treatment of migraine attacks, with or without aura, in adults Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00792636 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 4 Study Recruitment Status: Completed Generic Name: sumatriptan and naproxen sodium combination tablet Trade Name: sumatriptan tablet, naproxen sodium tablet Study Indication: Migraine Disorders

Keywords:
Versions (2) ▾
  1. 10/6/19
  2. 10/24/19
Copyright Holder:
GlaxoSmithKline
Uploaded on:

October 24, 2019

DOI:
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License:
Creative Commons BY-NC 3.0
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Sumatriptan and Naproxen Sodium for Acute Treatment of Migraine Attacks; NCT00792636

Baseline

  1. StudyEvent: ODM
    1. Baseline
Administrative Data
Date of Visit/Assessment
Status T-SMBP
Did the subject obtain the 3 days of Baseline T-SMBP measures?
Eligibility Question
Did the subject meet all the entry criteria?
No, please select all boxes corresponding to violations of any inclusion/ exclusion criteria - Inclusion Criteria
No, please select all boxes corresponding to violations of any inclusion/ exclusion criteria - Exclusion Criteria
Baseline Failure
Was this subject a Baseline failure?
Select primary reason
Specify
For Data Managers or Monitors only: Tick or untick this box to require the investigator to re- sign the case book
Pharmacogenetic (PGx) Research Withdrawal of Consent
Has subject withdrawn consent for PGx research?
Has a request been made for blood sample destruction?
Yes, check reason
Specify
Investigator Signature
Is this casebook ready to sign?
For Data Managers or Monitors only: Tick or untick this box to require the investigator to re- sign the case book
Vital Signs
mmHg
mmHg
mmHg
mmHg
mmHg
mmHg
bpm
mmHg
mmHg
mmHg
mmHg
IHS Headache Classification
Migraine without aura?
Typical aura with migraine headache?
Migraine History
migraines
What is the average duration of a typical untreated or unsuccessfully treated migraine attack?
Onset age of migraine attacks?
Does migraine headache pain usually recur within 24 hours of treatment?
days
days
Medical Conditions
Blood and lymphatic system disorders
Cardiac disorders
Ear and labyrinth disorders
Endocrine disorders
Eye disorders
Gastrointestinal disorders
Hepatobiliary disorders
Immune system disorders
Metabolism and nutrition disorders
Musculoskeletal and connective tissue disorders
Neoplasms benign, malignant and unspecified (including cysts and polyps)
Nervous system disorders
Psychiatric disorders
Renal and urinary disorders
Reproductive system and breast disorders
Respiratory, thoracic and mediastinal disorders
Skin and subcutaneous tissue disorders
Vascular disorders
Infections and infestations
Congenital, familial and genetic disorders
Cardiac Conditions
Endocrine Disorders
Thyroid hyperfunction disorder
Thyroid hypofunction disorder
Other [insert study specific classification] Conditions
Status
Baseline Risk Factors for CV Events
Does the subject have hyperlipidemia? (by history)?
Does the subject have diabetes mellitus? (by history)?
Does the subject have family history of premature coronary disease?
Does the subject use tobacco?
Is the subject obese? (Defined as BMI > or = to 30kg/m2)
Does the subject have history of inactivity (< 30 min/day)?
Does the subject have any chronic inflammatory condition?
Does the subject have elevated C - reactive protein (by history)?
Previous Treatment for Migraine
Previous use of medication for the acute treatment of migraine - Triptans
Previous use of medication for the acute treatment of migraine - NSAIDS
Previous use of medication for the acute treatment of migraine - Ergotamines
Previous use of medication for the acute treatment of migraine - Prescription narcotics
Previous use of medication for the acute treatment of migraine - Combination analgesics
Previous use of medication for the acute treatment of migraine - OTC analgesics
Previous use of medication for the acute treatment of migraine - Butalbital combinations
Previous use of medication for the acute treatment of migraine - TCAs
Previous use of medication for the acute treatment of migraine - Anti-convulsants
Previous use of medication for the acute treatment of migraine - SSRIs
Previous use of medication for the acute treatment of migraine - Beta-blockers
Previous use of medication for the acute treatment of migraine - Calcium channel-blockers
Previous use of medication for the acute treatment of migraine - Prophylactics
Previous use of medication for the acute treatment of migraine - SNRIs
Are there other categories to be entered?
Previous use of medication(s) for the acute treatment of migraine
Randomisation Number
Was the subject able to be randomised?