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Status unknownNCT04948164Updated Jul 7, 2021

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

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

The sponsor has not verified this record recently (last verified Jun 2021), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 2 years 10 months after the study started (first participant enrolled Aug 2018, registered Jun 2021).
Phase
Phase 3
Study type
Interventional
Enrollment
240
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Migraine in Adults

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03

In context

Migraine Disorders

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

    1. Age ≥18 years old and \<65 years old at the time of signing the informed consent form, regardless of gender;

      1. Diagnose patients who meet the criteria for the diagnosis of migraine without aura in the third trial version of the International Classification of Headache Diseases (ICHD-Ⅲ(β)) launched by the International Headache Association, and the degree is moderate or severe;
      1. The age of the patient's first migraine attack should be less than 50 years old, and must meet 5 or more migraine attacks without aura or a history of migraine without aura ≥ 1 year;
      1. The number of moderate or severe migraine attacks ≤6 and ≥1 per month within the first 3 months of enrollment, and at least a 48-hour headache interval;
      1. Ability to distinguish migraine patients from other types of headaches during headache attacks;
      1. Female patients who have not had unprotected sex in the 15 days before screening, and patients (regardless of men and women) who have no childbirth plans during the trial period and within 6 months after the end of the trial;
      1. Patients who have the ability to cooperate in observing curative effects and adverse events, and record headache diaries;
      1. Before starting any detailed procedures of this study, the patient has the ability to understand and sign a written informed consent form approved by the ethics committee

Exclusion criteria

Exclusion Criteria:

    1. Patients with migraine with aura, including but not limited to patients with brainstem migraine with aura and patients with hemiplegic migraine;

      1. Patients with average headache time ≥15 days per month in the 3 months before the test;
      1. Patients who have taken painkillers for a long time or overuse of painkillers (take painkillers for more than 10 days a month for 3 consecutive months);
      1. Abnormal renal function: creatinine value> upper limit of normal value;
      1. Patients with a history of severe liver disease or patients with significantly abnormal liver function: alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≥ 1.5 times the upper limit of normal or total bilirubin (TBIL) )≥1.5 times the upper limit of the normal value;
      1. History of major mental and neurological diseases such as depression and epilepsy;
      1. Patients who have taken central sedatives for a long time, such as barbiturates and benzodiazepines, including diazepam, lorazepam, etc.;
      1. Patients with severe cardiovascular diseases, such as coronary artery bypass surgery, or patients with a history of one of the following diseases, including but not limited to ischemic heart disease, such as angina (including Platts variant angina), Patients with a history of myocardial infarction, arrhythmia (such as pre-excitation syndrome) or disease-related symptoms, signs, or a significant ECG abnormal change;
      1. Patients with severe cerebrovascular diseases, including but not limited to cerebral ischemia, cerebral hemorrhage diseases;
      1. With severe peripheral vascular disease, such as Raynaud's syndrome;
      1. Patients whose blood pressure cannot be effectively controlled after drug treatment, systolic blood pressure (SBP)>140mmHg or diastolic blood pressure (DBP)>90mmHg;
      1. Take ergotamine or ergot derivatives (such as dihydroergotamine or ergonovine) or other 5-HT1 receptor agonists within 7 days before randomization;
      1. Patients who have taken MAOI within 14 days before screening;
      1. Patients who cannot stop using anticoagulant drugs (such as warfarin) or antiplatelet drugs (such as aspirin) during the trial;
      1. Patients who have previously undergone gastric resection or bypass surgery, or patients with a history of gastrointestinal bleeding, ulcers, or perforation;
      1. Patients suffering from sinusitis;
      1. Regularly take drugs for preventing headache attacks for more than 2 weeks before randomization, including but not limited to flunarizine, topiramate and Chinese patent medicines with similar effects;
      1. Known to triptan drugs, NSAIDs or their pharmaceutical excipients Patients with allergies, or have had aspirin asthma or aspirin triad (aspirin allergy, asthma, and nasal polyps);
      1. For patients with alcohol abuse and drug abuse, the standard for alcohol abuse is: drinking an average of more than 28 units per week (a unit of alcohol is equivalent to 250 mL of beer, 125 mL of wine or 20 mL of spirits or enthusiastic alcoholism); There are two types of drugs: one is narcotic drugs, such as heroin, marijuana and cannabis resin, opiates and morphine preparations, codeine, etc.; the other is psychotropic drugs, such as various hallucinogens and tetrahydrocannabinol, central stimulants Drugs, barbiturates, benzodiazepines, etc.;
      1. Patients who are pregnant, breastfeeding, or have a childbearing plan during the study period, including female patients of childbearing age who have a positive pregnancy test;
      1. Patients who have participated in any other clinical trials within 3 months before participating in this trial, and who plan to participate in other clinical trials of other drugs;
      1. The patient may not be able to complete the trial due to reasons, or the investigator believes that the patient is not suitable to participate in this trial. "
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
240 participants (estimated)

Study arms

  • Experimental
    Test group

    Drug: sumatriptan 85mg and naproxen sodium 500mg

  • Placebo comparator
    Control group

    Drug: Placebo

Interventions

  • Drugsumatriptan 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).

  • DrugPlacebo

    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)."

06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

1 of 1 sites recruiting
  • Peking University Third Hospital
    Beijing, China
    • Yingshuang Zhang · Contact · 18511650863
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 7, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04948164
Lead sponsor
Peking University Third Hospital
Collaborators
Jiangsu Provincial People's Hospital, The First Affiliated Hospital of Guangzhou Medical University, Second Hospital of Jilin University, The Second Affiliated Hospital of Kunming Medical University, The Second Hospital of Nanjing Medical University, The Affiliated Hospital of Qingdao University, Beijing Friendship Hospital, West China Hospital, Second Affiliated Hospital of Wenzhou Medical University, The Third Xiangya Hospital of Central South University
Responsible party
Sponsor
First posted
Jul 1, 2021
Start date
Aug 1, 2018
Primary completion
Dec 1, 2021 (estimated)
Completion
Dec 1, 2021 (estimated)
Last update
Jul 7, 2021

Study contacts

Yingshuang Zhang
Contact
zhangys0317@126.com
18511650863
Xiaoxuan Liu
Contact
13910982101
Yingshuang Zhang
principal investigator · Peking University Third Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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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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