NCT04948164

Study of Sumatriptan Naproxen Sodium Succinate Tablets for the Treatment of Acute Migraine Attacks

A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial of the Efficacy and Safety of Sumatriptan Naproxen Sodium Succinate Tablets for the Treatment of Acute Migraine Attacks.

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Peking University Third Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Migraine in Adults

Interventions

Type	Name	Description
DRUG	sumatriptan 85mg and naproxen sodium 500mg	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).
DRUG	Placebo	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)."

Timeline

• Start date: 2018-08-01
• Primary completion: 2021-12-01
• Completion: 2021-12-01
• First posted: 2021-07-01
• Last updated: 2021-07-07

Locations

1 site across 1 country: China