A multicentre prospective randomized double-blind placebo-controlled study to evaluate the efficacy and safety of ketorolac 30 mg sublingual tablet in the acute treatment of migraine headache
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 696
- 试验地点
- 18
- 主要终点
- The proportion of patients achieving Pain Free at 2 hours post dose as compared to placebo
研究概览
简要总结
Efficacy of Ketorolac parenteral formulations in migraine attack has been studied in many clinical trials. In a comparative clinical study of intravenous Ketorolac vs. nasal Sumatriptan conducted in 29 patients with migraine headache demonstrated that intravenous ketorolac produced greater pain reduction in pain compared to nasal Sumatriptan. A systemic review on 141 patients treated with acute migraine stated that, Ketorolac was more effective than intranasal sumatriptan. While there was no difference in pain relief between ketorolac and phenothiazine agents.
Availability of Ketorolac Sublingual tablets will help in quick and easy administration of the treatment by the patient, without aid of the medical staff and thus may lead to quick relief from migraine pain.
Based on above information, Troikaa proposes to conduct this phase III Clinical Trial for regulatory approval of Ketorolac Tromethamine Sublingual 30 mg for treatment of Migraine headache.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and female adult patients aged 18 to 65 years and having the diagnosis of migraine with or without aura according to the International Headache Societys criteria for migraine ICHD3 2018 History of diagnosis of migraine before the age of 50 years Subjects must be compliant with self administration of medication and willing to fillup the migraine diary provided to them as required for the study At least a 1year history of migraine with or without aura consistent with a diagnosis according to the International Classification of Headache Disorders 3rd edition beta version ICHD3 Migraine episodes that are separated by at least 72 hours of headache pain freedom will be included History of 2 to 8 migraine attacks per month with moderate to severe headache pain in each of the 3 months prior to Screening.
排除标准
- •All headache types other than migraine Has taken medication for acute treatment of headache including acetaminophen nonsteroidal anti inflammatory drugs NSAIDs triptans ergotamine opioids or combination analgesics on 10 or more days per month in the previous 3 months Required hospital treatment of a migraine attack 3 or more times in the previous 6 months Has a chronic non headache pain condition requiring daily pain medication Has a history of malignancy in the prior 5 years except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer Has a history of any prior gastrointestinal conditions eg diarrhea syndromes inflammatory bowel disease that may affect the absorption or metabolism of the investigational product participants with prior gastric bariatric interventions which have been reversed are not excluded Patients with active peptic ulcer disease recent gastrointestinal bleeding or perforation Patients with a history of peptic ulcer disease or gastrointestinal bleeding Elderly patients at a greater risk for serious gastrointestinal events age more than 65 years Has a history of hepatitis within the previous 6 months Pregnancy or breastfeeding Subjects who within one year had a clinically significant medical history of bleeding problems coagulation abnormalities hemorrhagic disease anemia bone marrow suppression immunosuppression motility dysfunction or any condition that could interfere with the absorption distribution metabolism or excretion of the study medication Subjects who are diagnosed and or treated for inflammatory bowel disease or pancreatic disease serious cardiovascular disease or history of serious cardiovascular disease or stroke renal hepatic endocrine pulmonary neurologic disease Type I or II diabetes mellitus uncontrolled hypertension or malignancy not in remission Subjects who are taking drugs like antiplatelet agents and or anticoagulants Uncontrolled hypertension Systolic greater than 150 and Diastolic greater than 95 mm of Hg.
结局指标
主要结局
The proportion of patients achieving Pain Free at 2 hours post dose as compared to placebo
时间窗: Pain intensity difference PID at each evaluation 30 minutes and 1 1 5 2 3 4 6 12 24 48 72 96 120 hours post dose
Pain freedom defined as a reduction in headache severity from moderate severe at baseline to no pain at 2 hours after the initial dose
时间窗: Pain intensity difference PID at each evaluation 30 minutes and 1 1 5 2 3 4 6 12 24 48 72 96 120 hours post dose
The proportion of patients with freedom from the most bothersome symptom MBS from among nausea photophobia and phonophobia at 2 hours after the initial dose
时间窗: Pain intensity difference PID at each evaluation 30 minutes and 1 1 5 2 3 4 6 12 24 48 72 96 120 hours post dose
次要结局
- Percentage of Participants with Pain Relief at 2 Hours after the Initial Dose Time Frame Baseline Predose to 2 hours after the initial dose(Percentage of Participants With Sustained Pain Relief From 2 to 24 Hours After Initial Dose Time Frame 2 to 24 hours after initial dose)