EUCTR2005-000583-28-AT进行中（未招募）不适用
EFFICACY AND TOLERABILITY OF NIMESULIDE FOR THE TREATMENT OF MIGRAINE TTACKS: A RANDOMISED, MULTICOUNTRY, DOUBLE BLIND, PLACEBO CONTROLLED, CROSS-OVER TRIA
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 162
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
- 性别
- All
入选标准
- •Adult males and females out-patients aged > 18 to < 65 years;
- •Migraine with and / or without aura for more than 1 year following the ICHD II ( The International Classification of the Headache Disorders 2004 ) ( Appendix no. 3 )
- •Frequency of attacks of more than one but less than 6 attacks per month ( in any case less than fifteen headache days per month );
- •Age at migraine onset < 50 years;
- •Ability to differentiate headache attacks that are not migraine from the very beginning of the attack;
- •Physical examination results, including vital signs within the reference ranges or clinically acceptable to the Investigator;
- •Able and willing to give written informed consent;
- •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
- •Patients with more than one out of three attacks on waking;
- •Patients with known hypersensitivity to nimesulide or to any of the excipients of the products;
- •Presence or intention of pregnancy and breast feeding;
- •Patients with hepatic impairment;
- •Severe renal impairment or severe heart failure;
- •Patients with abnormal routine laboratory biochemistry parameters (especially SGOT, GPT, ?GT and bilirubin) at screening.
- •Patients with metabolic or other diseases like malignancy and major psychiatric disorders that, in the view of the investigator, could compromise the patient’s participation in the study;
- •Patients with history of hypersensitivity reactions (i.e.: bronchospasm, rhinitis, urticaria) in response to acetylsalicylic acid or other non steroidal anti-inflammatory drugs.
- •Patients with obstructive pulmonary disease;
- •Concurrent treatment with glucocorticoids (unless given as supplements);
- •Patients with active gastric or duodenal ulcer, a history of recurrence ulceration or gastrointestinal bleeding, cerebrovascolar bleeding or other active bleeding or bleeding disorders;
- •Patients with severe coagulation disorders;
- •Patients taking drugs during the previous three months in doses likely to produce amnesia during the study period (e.g. benzodiazepines, psychotropic and major tranquillisers);
- •Treatments with oral contraceptive or prophylactic medication for migraine if taken for less than 2 months before the study start and/or modified during the trial;
- •Patients with known contraindication to nimesulide or to any of the excipients of the products;
- •Patients with known hepatotoxicity reaction in response to nimesulide;
- •Patients using nimesulide or other NSAIDs and/or ASA on a daily basis;
- •Patients who abuse of alcohol or other drugs;
- •Patients who are treated with hepatotoxic drugs;
- •Patients who have used any investigational drug and/or participated in any clinical trial within 3 months of entry to this study;
- •Patients unable to give a valid informed consent or unable to properly follow the protocol.
- •Employees of the investigator or study centre (i.e., principal investigator, sub-investigator, study coordinators, other study staff, employees, or contractors of each), with direct involvement in the proposed study or other studies under the direction of that investigator and/or study centre, as well as family members of the employees or the investigator.
研究者
相似试验
进行中（未招募）
不适用
Efficacy and tolerability of nimesulide for the treatment of migraine attacks, a randomised, double blind, placebo controlled cross-over trialEUCTR2005-000583-28-ITHELSINN HEALTHCARE SA162
进行中（未招募）
不适用
Activity, tolerability and safety of Temsirolimus in women with ovarian cancer who progressed during the previous platinum chemotherapy alternatively within 6 months from completion of therapy or advanced endometrial carcinomaplatinum-refractory ovarian carcinoma or advanced endometrial carcinomaMedDRA version: 15.1Level: PTClassification code 10014733Term: Endometrial cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 15.1Level: PTClassification code 10066697Term: Ovarian cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2011-000299-33-DEAGO Research GmbH
已完成
不适用
Clinical study to assess the tolerance and efficacy of a nasal spray: Stérimar Stop & Protect Rhume/Cold for relief of symptoms in patients with an upper respiratory tract infection (common cold)pper respiratory tract infection (common cold)RespiratoryISRCTN14067635Church & Dwight (United States)102
已完成
不适用
The effectiveness of systematic tinidazole in the treatment of periodontitis in smokersModerate to advanced periodontitis in smokers.Factors influencing health status and contact with health servicesIRCT2015022521195N2Shiraz University of Medical Sciences, International Branch60
进行中（未招募）
1 期
Evaluation de l’efficacité du temsirolimus chez des patients récidivant d’un cancer de la vessie après une première ligne de chimiothérapie. Essai clinique de phase II multicentrique. - VESTOREUCTR2009-011049-15-FRInstitut Bergonié - Département d’Oncologie Médicale