Trial · NCT06868953
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 2 hour-pain freedom | 2 hours after taking combination of sumatriptan 85 mg and naproxen 500 mg | Percentage of patients reporting complete pain relief within 2 hours after taking the combination of sumatriptan 85 mg and naproxen 500 mg (2h-pain freedom). |
| Secondary | 1 hour-pain freedom | 1 hour after taking combination of sumatriptan 85 mg and naproxen 500 mg | Percentage of patients reporting complete pain relief within 1 hour after taking the combination of sumatriptan 85 mg and naproxen 500 mg (1h-pain freedom). |
| Secondary | 2 hour-pain relief | 2 hours after taking combination of sumatriptan 85 mg and naproxen 500 mg | Percentage of patients reporting a 50% reduction in pain intensity within 2 hours after taking the combination of sumatriptan 85 mg and naproxen 500 mg (2h-pain relief) |
| Secondary | Disappearence of Most Bothersome Symptom | 2 hours after taking combination of sumatriptan 85 mg and naproxen 500 mg | Percentage of patients experiencing the disappearance of the Most Bothersome Symptom (MBS: the accompanying symptom of the attack considered most disabling by the patient) within 2 hours after taking the combination tablet of sumatriptan 85 mg/naproxen 500 mg. |
| Secondary | Presence or absence of associated symptoms (nausea, vomiting, photophobia, or phonophobia) | 1-48 hours after taking combination of sumatriptan 85 mg and naproxen 500 mg | Presence or absence of associated symptoms (nausea, vomiting, photophobia, or phonophobia) at predefined time intervals of 1, 2, 3, 4, 6, 8, 24, and 48 hours. |
| Secondary | 24 hour-sustained pain freedom | 24 hours after taking combination of sumatriptan 85 mg and naproxen 500 mg | Percentage of patients experiencing complete pain relief within 2 hours after taking the combination of sumatriptan 85 mg and naproxen 500 mg, with sustained benefit in the following 24 hours (24h-sustained pain freedom). |
| Secondary | 24 hour sustained pain relief | 24 hours after taking combination of sumatriptan 85 mg and naproxen 500 mg | Percentage of patients experiencing a 50% reduction in pain intensity within 2 hours after taking the combination of sumatriptan 85 mg and naproxen 500 mg, with sustained benefit in the following 24 hours (24h-sustained pain relief). |
| Secondary | headache recurrence | 2 hours after taking combination of sumatriptan 85 mg and naproxen 500 mg | Definition of the moment of possible migraine pain recurrence (headache recurrence), as well as its intensity within 24 and 48 hours following the administration of the medication (limited to patients who experienced pain freedom within 2 hours). |
| Secondary | use of rescue medication | 24 hours after taking combination of sumatriptan 85 mg and naproxen 500 mg | Use of rescue medications and evaluation of the time interval between the first and second dose. |
| Secondary | Variation of Migraine Specific Quality of Life Questionnaire score at week 24 | week 24 after taking the first dose of combination of sumatriptan 85 mg and naproxen 500 mg | Changes in scores of the Migraine Specific Quality of Life Questionnaire administered at week 24 compared to baseline |
| Secondary | Variation of Migraine Specific Quality of Life Questionnaire score at week 24 | week 24 after taking the first dose of combination of sumatriptan 85 mg and naproxen 500 mg | Changes in scores of the Migraine Specific Quality of Life Questionnaire administered at week 24 compared to week 12 |
| Secondary | Variation of Migraine Interictal Burden Scale score at week 24 | week 24 after taking the first dose of combination of sumatriptan 85 mg and naproxen 500 mg | Changes in scores of the Migraine Specific Quality of Life Questionnaire administered at week 24 compared to baseline |
| Secondary | Variation of Migraine Interictal Burden Scale score at week 24 | week 24 after taking the first dose of combination of sumatriptan 85 mg and naproxen 500 mg | Changes in score of the Migraine Interictal Burden Scale administered at week 24 compared to week 12 |
| Secondary | Variation of Headache Impact Test score at week 24 | week 24 after taking the first dose of combination of sumatriptan 85 mg and naproxen 500 mg | Changes in score of Headache Impact Test scale administered at week 24 compared to baseline |
| Secondary | Variation of Headache Impact Test score score at week 24 | week 24 after taking the first dose of combination of sumatriptan 85 mg and naproxen 500 mg | Changes in score of Headache Impact Test scale administered at week 24 compared to week 12 |
| Secondary | Patient Global Impression of Change | week 24 after taking the first dose of combination of sumatriptan 85 mg and naproxen 500 mg | Collection of subjective feedback from the patient regarding their experience with the medication, assessing patient satisfaction, ease of use of the medication, and perceived effectiveness with Patient Global Impression of Change scale |
| Secondary | Adverse events occurrence | 48 hours after taking the first dose of combination of sumatriptan 85 mg and naproxen 500 mg | Definition of the type and number of adverse events occurring within 48 hours of taking the combination of sumatriptan 85 mg and naproxen 500 mg through a specific questionnaire (event details, duration, severity, and actions taken). |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT06868953/registered