EUCTR2007-000493-23-GB进行中（未招募）1 期
A Comparison of Two Analgesic Products for the Treatment of Headache - A Comparison of Two Analgesic Products for the Treatment of Headache
GlaxoSmithKline Consumer Healthcare0 个研究点目标入组 500 人开始时间: 2011年3月24日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Male or female subjects, aged 18-65 years inclusive, diagnosed with tension-type
- •headache in accordance with the criteria established by the International Headache
- •Society 2004(3). Subjects must experience between two and ten headaches of
- •moderate or severe intensity per month and must gain at least some relief from OTC
- •analgesics.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1) Disease
- •a) Clinician diagnosed migraine headache, post-concussion headache or cluster headache within the last year.
- •b) Menstrual headache (which in the opinion of the investigator the subject cannot differentiate from tension-type headache).
- •c) In the opinion of the Investigator, significant head/neck injury or change in headache pattern during the previous 6 months.
- •d) Current or relevant previous history of serious, severe or unstable physical or psychiatric illness, any medical disorder (except headache) that may require treatment or make the subject unlikely to fully complete the study, or any condition that presents undue risk from study medication or procedures.
- •e) Severe liver or kidney disease.
- •f) Current or history of stomach ulcer or other stomach disorder.
- •g) History of bronchospasm, rhinitis or urticaria associated with aspirin or Nonsteroidal Anti-inflammatory Drugs (NSAIDs).
- •2) Medications
- •a) Current use of prescription medication for headache.
- •b) Current use of antipsychotic, antidepressant, muscle relaxant, sedative or antiepileptic medications.
- •c) Continuous treatment with prescription doses of analgesics or NSAIDs.
- •d) Use of analgesics on more than 10 days per month to treat headache.
- •Recent history (within one year) of alcohol abuse or other substance abuse.
- •4) Allergy/Intolerance
- •Known or suspected intolerance or hypersensitivity to the study treatments or rescue medication (paracetamol, caffeine or ibuprofen) or any of their stated ingredients.
- •5) Pregnancy
- •Women who are pregnant or who have a positive urine pregnancy test.
- •6) Breast-feeding
- •Women who are breast–feeding.
- •7) Clinical Trials/Experimental Medication
- •a) Participation in another clinical trial or receipt of an investigational drug within 30 days of the screening visit.
- •b) Previous participation in this study.
- •8) Personel
- •An employee of the sponsor or the study site or members of their immediate family.
研究者
相似试验
已完成
4 期
ANALGESIC EFFICACY OF TWO PREPARATIONS OF INTRAVENOUS PARACETAMOL FOR DAY CARE SURGERIES: A COMPARITIVE STUDY.CTRI/2018/03/012864MIMER MEDICAL COLLEGE TALEGAO80
已完成
不适用
Comparing the pain releiving effect of two concentrations of Levobupivacaine in scan guided type 2 Quadratus lumborum block in patients undergoing Gall bladder removal surgeryCTRI/2023/02/049741Institue of Liver and Biliary Sciences ILBS60
已完成
4 期
To compare effect of two different pain relieving blocks in patients undergoing laparoscopic inguinal hernia surgeryCTRI/2020/02/023230Department of Anaesthesia and intensive care42
招募中
4 期
se of different doses of IV dexamethasone to prolong the post-operative pain relief in patients undergoing surgery below the umbilicus under spinal anesthesiaCTRI/2023/06/053640Aashish Kiraan B
已完成
不适用
Analgesic efficacy of interpleural and paravertebral blockISRCTN13324055The Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)70