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Efficacy and Tolerability of TREXIMA™ (sumatriptan 85mg/naproxen sodium 500mg) ID 101999 - Subject Diary

- 1/15/19 - 1 form, 12 itemgroups, 40 items, 1 language
Itemgroups: Administrative Data, Migraine Symptoms, Date and Time Study Medication Taken, Details of Migraine Headache Pain and Symptoms, ALLODYNIA QUESTIONNAIRE (Complete at time of dosing), Details of Work Ability, ALLODYNIA QUESTIONNAIRE (Complete 2 hours after dosing), Recurrence, Medications Taken, Productivity, Productivity: Affect of Migraine Attack on work and non-work related activities, PATIENT PERCEPTION OF MIGRAINE QUESTIONNAIRE - REVISED (PPMQ-R)
This ODM file contains the form for the subject diary. To be filled out throughout the study. Study ID: 101999 Clinical Study ID: 101999 Study Title: A randomized, double-blind, parallel group, placebo-controlled, single-attack evaluation of the efficacy and tolerability of TREXIMA™ (sumatriptan 85mg/naproxen sodium 500mg)* tablets vs placebo when administered during the mild pain phase of a migraine Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: sumatriptan Trade Name: Imitrex ,Imiject ,Imigran Study Indication: Migraine Disorders Subject Diary Instructions: Important Reminders: • All Pages: It is very important that you complete the diary information as accurately as possible and in a timely manner. Page 1: • Do NOT treat any headache with study medication until study personnel call you about your lab and ECG results. • Enter the date and time your migraine headache pain started and the date and time you took study medication. • Take the study medication ONLY within one hour of the start of migraine head pain and ONLY if your headache pain is still MILD. • If you wake up with mild migraine headache pain, you should take the study medication as soon as possible after awakening. • If you wake up with moderate or severe headache pain, you should NOT take the study medication to treat the headache. You should not use the study medication to treat your migraine headache if you have used: • nonsteroidal anti-inflammatory drugs such as ibuprofen (Advil or Motrin), naproxen (Aleve), aspirin (exception is aspirin not exceeding 325mg if taken for cardiovascular health) within 24 hours before taking study medication • an ergotamine-containing or ergot-type medication like dihydroergotamine or methysergide within 24 hours before taking study medication • a triptan (such as Imitrex, Zomig, Maxalt, Relpax, Amerge, Axert, or Frova) within 24 hours before taking study medication • medications for nausea or vomiting, narcotics, or other headache medications within 24 hours before taking study medication • any other pain medications (such as Tylenol or acetaminophen) within 6 hours before taking study medication Page 2: Complete this page at time of dosing with study medication and 30 minutes, 1 hour, 2 hours, and 4 hours after taking study medication. Page 3: Complete this page at time of dosing with study medication. Page 4: Complete this page at time of dosing with study medication and at 2 and 4 hours after dosing with study medication. Page 5: Complete this page at 2 hours after dosing with study medication. Page 6: Complete this page at 24 hours after taking study medication. Page 7: Complete this page. You should not use a medication for pain, nausea, or vomiting within 2 hours after taking study medication. If you have migraine pain from 2 to 24 hours after taking the study medication, you may take other headache medication that the study doctor has told you is acceptable to use. These include Tylenol (acetaminophen), drugs for nausea or vomiting, and narcotics. Pages 8, 9 - 12: Complete these pages 24 hours after taking study medication. • Contact the investigator if you feel any unusual symptoms after taking the study medication. • Ask the investigator if you are unsure of the above instructions. GENERAL INSTRUCTIONS FOR DIARY COMPLETION • Use black ink and print neatly and legibly. • If you make a mistake, draw a single line through the incorrect entry. • Do not 'write over' or erase an incorrect entry, or re-copy the original page. • Do not use correction materials (such as correction fluid or tape) on this diary card. DATE • Record dates in DD MMM YY format (for example: 15 JAN 04). • Use the first three letters of each month as the abbreviation for the months (e.g., JAN, FEB, MAR). TIME • Record time in 24-hour clock format unless specified otherwise, per conversion chart below. a.m. Midnight = 00:00 1:00 = 01:00 2:00 = 02:00 3:00 = 03:00 4:00 = 04:00 5:00 = 05:00 6:00 = 06:00 7:00 = 07:00 8:00 = 08:00 9:00 = 09:00 10:00 = 10:00 11:00 = 11:00 p.m. Noon = 12:00 1:00 = 13:00 2:00 = 14:00 3:00 = 15:00 4:00 = 16:00 5:00 = 17:00 6:00 = 18:00 7:00 = 19:00 8:00 = 20:00 9:00 = 21:00 10:00 = 22:00 11:00 = 23:00 Note: Midnight = 00:00 is the start of the new day, not the end of the previous day. Page 1: Migraine Symptoms - Date and Time Study Medication Taken Page 2: Details of Migraine Headache Pain and Symptoms Page 3: Allodynia Questionnaire (Complete at time of dosing) Page 4: Details of WOrk Ability Page 5: Allodynia Questionnaire (Complete 2 hours after dosing) Page 6: Recurrence Page 7: Medications Taken Page 8: Productivity Page 9: PPMQ-R Reminder to Site Personnel: Upon return of the completed diary, review the diary with the subject and address discrepancies while the subject is in the clinic. Subject Reminder: Take the study medication ONLY within one hour of the start of migraine head pain and ONLY if your headache pain is still MILD.

Efficacy and Tolerability of TREXIMA Tablets vs. Placebo During Mild Migraine Study ID 101998 - Demographics

- 1/17/19 - 1 form, 3 itemgroups, 14 items, 1 language
Itemgroups: Administrative Data, Demography, Race
Study ID: 101998 Clinical Study ID: 101998 Study Title: A randomized, double-blind, parallel group, placebo-controlled, single-attack evaluation of the efficacy and tolerability of TREXIMA™ (sumatriptan 85mg/naproxen sodium 500mg)* tablets vs placebo when administered during the mild pain phase of a migraine Patient Level Data Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier Sponsor GlaxoSmithKline Collaborators N/A Phase Phase 3 Study Recruitment Status Completed Generic Name sumatriptan Trade Name Imitrex ,Imiject ,Imigran Study Indication Migraine Disorders The purpose of this form is to document the subjects demographic data. It should be filled out at the screening visit.

Efficacy and Tolerability of TREXIMA™ (sumatriptan 85mg/naproxen sodium 500mg) ID 101999 - Headache Impact Test (HIT-6) Score, IHS Headache Classification, Migraine History, Previous Treatment for Migraine

- 9/20/21 - 1 form, 5 itemgroups, 33 items, 1 language
Itemgroups: Administrative Data, Head Impact Test (HIT-6) Score, IHS Headache Classification1, Migraine History, Previous Treatment for Migraine
This ODM-file contains the form to document the Head impact test (HIT-6) Score, the IHS Headache classification, the migraine history and the previous migraine treatment. To be assessed at screening. Study ID: 101999 Clinical Study ID: 101999 Study Title: A randomized, double-blind, parallel group, placebo-controlled, single-attack evaluation of the efficacy and tolerability of TREXIMA™ (sumatriptan 85mg/naproxen sodium 500mg)* tablets vs placebo when administered during the mild pain phase of a migraine Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: sumatriptan Trade Name: Imitrex ,Imiject ,Imigran Study Indication: Migraine Disorders

TXA107979: Sumatriptan and Naproxen Sodium for the Acute Treatment of Migraine NCT00843024 - Attack 1 Diary

- 9/20/21 - 1 form, 9 itemgroups, 33 items, 1 language
Itemgroups: Date of Visit/Assessment, Migraine attack symptoms, IP, Migraine attack headache pain and symptoms, Medications taken, Ability to function, Investigational product accountability, Investigational Product, Language used in diary assessment
Study ID: 107979 Clinical Study ID: TXA107979 Study Title: TXA107979: A Randomized, Multicenter, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of a Combination Product Containing Sumatriptan and Naproxen Sodium for the Acute Treatment of Migraine in Adolescents Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00843024 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: sumatriptan/naproxen Trade Name: Treximet Study Indication: Migraine Disorders CRF Seiten: 879-993

Efficacy and Tolerability of TREXIMA™ (sumatriptan 85mg/naproxen sodium 500mg) ID 101999 - Study Conclusion, Pregnancy Information and Investigator Comment Log

- 9/27/21 - 1 form, 5 itemgroups, 14 items, 1 language
Itemgroups: Administrative Data, Pregnancy Information, Study Conclusion, Investigator Comment Log, Investigator's Signature
This ODM file contains the form to document pregnancy information at the end of the study, the study conclusion and also includes an investigator's comment log. Study ID: 101999 Clinical Study ID: 101999 Study Title: A randomized, double-blind, parallel group, placebo-controlled, single-attack evaluation of the efficacy and tolerability of TREXIMA™ (sumatriptan 85mg/naproxen sodium 500mg)* tablets vs placebo when administered during the mild pain phase of a migraine Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: sumatriptan Trade Name: Imitrex ,Imiject ,Imigran Study Indication: Migraine Disorders

Efficacy and Tolerability of TREXIMA™ (sumatriptan 85mg/naproxen sodium 500mg) ID 101999 - Serious Adverse Event

- 11/9/18 - 1 form, 14 itemgroups, 56 items, 1 language
Itemgroups: Administrative Data, Serious Adverse Event, SECTION 1, SECTION 2: Seriousness, SECTION 3 Demography Data, SECTION 4 If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?, SECTION 5 Possible Causes of SAE Other Than Investigational Product(s), SECTION 6 RELEVANT Medical Conditions, SECTION 7 Other RELEVANT Risk Factors, SECTION 8 RELEVANT Concomitant Medications, SECTION 9 Details of Investigational Product(s), SECTION 10 Details of relevant Assessments, SECTION 11 Narrative Remarks, Investigator's name and signature
This ODM file contains the form to document all serious events that are temporally associated with the use of the study medication. Study ID: 101999 Clinical Study ID: 101999 Study Title: A randomized, double-blind, parallel group, placebo-controlled, single-attack evaluation of the efficacy and tolerability of TREXIMA™ (sumatriptan 85mg/naproxen sodium 500mg)* tablets vs placebo when administered during the mild pain phase of a migraine Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: sumatriptan Trade Name: Imitrex ,Imiject ,Imigran Study Indication: Migraine Disorders

Efficacy and Tolerability of TREXIMA™ (sumatriptan 85mg/naproxen sodium 500mg) ID 101999 - Non-Serious Adverse Event

- 10/30/18 - 1 form, 3 itemgroups, 11 items, 1 language
Itemgroups: Administrative Data, Experience of a Non-Serious Adverse Event, Non-Serious Adverse Events Details
This ODM file contains the form to document all non-serious adverse events that are temporally associated with the use of the study medication. Study ID: 101999 Clinical Study ID: 101999 Study Title: A randomized, double-blind, parallel group, placebo-controlled, single-attack evaluation of the efficacy and tolerability of TREXIMA™ (sumatriptan 85mg/naproxen sodium 500mg)* tablets vs placebo when administered during the mild pain phase of a migraine Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: sumatriptan Trade Name: Imitrex ,Imiject ,Imigran Study Indication: Migraine Disorders

Efficacy and Tolerability of TREXIMA™ (sumatriptan 85mg/naproxen sodium 500mg) ID 101999 - Concomitant Medication

- 10/30/18 - 1 form, 3 itemgroups, 8 items, 1 language
Itemgroups: Administrative Data, Concomitant Medication, List of Concomitant Medication
This ODM file contains the form for documentation of any concomitant medication. To be assessed at screening and re-assessed at every visit. Study ID: 101999 Clinical Study ID: 101999 Study Title: A randomized, double-blind, parallel group, placebo-controlled, single-attack evaluation of the efficacy and tolerability of TREXIMA™ (sumatriptan 85mg/naproxen sodium 500mg)* tablets vs placebo when administered during the mild pain phase of a migraine Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: sumatriptan Trade Name: Imitrex ,Imiject ,Imigran Study Indication: Migraine Disorders

TXA107979: Sumatriptan and Naproxen Sodium for the Acute Treatment of Migraine NCT00843024 - LOG Visit

- 6/20/18 - 1 form, 15 itemgroups, 122 items, 2 languages
Itemgroups: Date of Visit/Assessment, Adverse event, Log status, Concomitant Medications, Non-serious adverse event, Report, Randomisation, Serious Adverse Event, Intensity changes, Seriousness, Relevant concomitant/treatment medications, Relevant diagnostic results, investigational product, General narrative comments, Non clinical
Study ID: 107979 Clinical Study ID: TXA107979 Study Title: TXA107979: A Randomized, Multicenter, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of a Combination Product Containing Sumatriptan and Naproxen Sodium for the Acute Treatment of Migraine in Adolescents Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00843024 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: sumatriptan/naproxen Trade Name: Treximet Study Indication: Migraine Disorders CRF Seiten: 879-993

TXA107979: Sumatriptan and Naproxen Sodium for the Acute Treatment of Migraine NCT00843024 - End of Study

- 6/19/18 - 1 form, 6 itemgroups, 21 items, 1 language
Itemgroups: Date of Visit/Assessment, Status of Treatment Blind, Pregnancy, Withdrawal of Consent for PGx (DNA)/Sample Destruction, Study conclusion, Investigators signature
Study ID: 107979 Clinical Study ID: TXA107979 Study Title: TXA107979: A Randomized, Multicenter, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of a Combination Product Containing Sumatriptan and Naproxen Sodium for the Acute Treatment of Migraine in Adolescents Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00843024 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: sumatriptan/naproxen Trade Name: Treximet Study Indication: Migraine Disorders CRF Seiten: 879-993

Efficacy and Tolerability of TREXIMA™ (sumatriptan 85mg/naproxen sodium 500mg) ID 101999 - Childbearing Potential, Birth Control Methods and Medical Conditions

- 11/9/18 - 1 form, 4 itemgroups, 29 items, 1 language
Itemgroups: Administrative Data, Child-bearing Potential (Complete for Female Subjects Only), Birth Control Methods, Medical Conditions
This ODM-file contains the form to document the childbearing potential, birth control methods and medical conditions of the subject. To be assessed at screening. Study ID: 101999 Clinical Study ID: 101999 Study Title: A randomized, double-blind, parallel group, placebo-controlled, single-attack evaluation of the efficacy and tolerability of TREXIMA™ (sumatriptan 85mg/naproxen sodium 500mg)* tablets vs placebo when administered during the mild pain phase of a migraine Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: sumatriptan Trade Name: Imitrex ,Imiject ,Imigran Study Indication: Migraine Disorders

Efficacy and Tolerability of TREXIMA™ (sumatriptan 85mg/naproxen sodium 500mg) ID 101999 - Investigatioinal Product Use and Status of Treatment Blind

- 11/2/18 - 1 form, 3 itemgroups, 7 items, 1 language
Itemgroups: Administrative Data, Investigational Product Use, Status of Treatment Blind
This ODM-file contains the form to document the investigational product use and the status of treatment blind. To be assessed at the final visit. Study ID: 101999 Clinical Study ID: 101999 Study Title: A randomized, double-blind, parallel group, placebo-controlled, single-attack evaluation of the efficacy and tolerability of TREXIMA™ (sumatriptan 85mg/naproxen sodium 500mg)* tablets vs placebo when administered during the mild pain phase of a migraine Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: sumatriptan Trade Name: Imitrex ,Imiject ,Imigran Study Indication: Migraine Disorders

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