A Phase 3 interventional study of sumatriptan 85mg and naproxen sodium 500mg and Placebo in Migraine in Adults, sponsored by Peking University Third Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-07-07.
Sponsored by Peking University Third Hospital · Phase 3, Interventional, and Treatment
A multicenter, randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of sumatriptan naproxen sodium succinate tablets in the treatment of acute migraine attacks.
Migraine is a common chronic nerve vascular disease, the disease characteristic to break out repeatedly, one side or both sides of the pulsatile partial side head, severe headache and can combine autonomic nervous system dysfunction such as nausea, vomiting, photophobia, and fear the symptom such as, about one-third of patients with migraine aura symptoms can appear before the onset of the nervous system. Sulaptan is a 5-HT1 receptor agonist with a high affinity for binding to 5-HT1b and 5-HT1D receptors. Naproxen is an NSAID that inhibs the synthesis of inflammatory mediators. Thus, sulaptan and naproxen alleviate migraine through different pharmacological mechanisms of action. For this test center, randomized, double-blind, placebo-controlled, parallel-group Ⅲ phase of clinical trial, aimed to verify shu Ma Putan naproxen sodium treatment of acute migraine headache, headache complete remission rate after 2 hours, evaluation of succinic acid shu Ma Putan naproxen sodium tablets for efficacy and safety of the treatment of acute migraine attacks.
1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.
This study's planned enrollment of 240 is above the median of 80 across 1,175 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →Peking University Third Hospital is the lead sponsor of 735 studies on the registry; 262 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Age ≥18 years old and \<65 years old at the time of signing the informed consent form, regardless of gender;
Exclusion Criteria:
Patients with migraine with aura, including but not limited to patients with brainstem migraine with aura and patients with hemiplegic migraine;
Drug: sumatriptan 85mg and naproxen sodium 500mg
Drug: Placebo
Subjects took 1 tablet of the study drug (each containing sumatriptan 85mg and naproxen sodium 500mg) within 1h of an acute migraine attack of mild severity, and if the headache progressed to moderate severity within 2 hours, they could take the remedial drug phenol chai (each containing acetaminophen 500mg and caffeine 65mg).
subjects were given one tablet of placebo within 1 h of an acute migraine attack with mild severity, and if the headache progressed to moderate severity within 2 hours, they were given the remedial drug phenol chai (each tablet contains acetaminophen 500 mg and caffeine 65 mg)."
Relief rate
Complete headache relief rate within 2 hours after taking the drug for the first time (proportion of subjects without headache)
Time frame: 2hr after taking the drug
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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Peking University Third Hospital