EUCTR2014-003790-41-ES进行中（未招募）不适用
Randomised, double-blinded, placebo and active comparator controlled exploratory clinical trial to assess the efficacy and safety of a triple combination of Ibuprofen, magnesium and ascorbic acid in Temporo-Mandibular Joint (TMJ) dysfunction syndrome.
Spherium Biomed0 个研究点开始时间: 2015年2月9日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •1) Patients previously diagnosed or in the screening of TMD who are in acute phase of articular +/- muscle pain (either relapse or onset of pain symptoms), with or without restriction of mouth opening (whether they are carriers of joint stabilization splint or not) (groups the Research Diagnostic Criteria for Temporomandibular Disorders (RDC / TMD) Ia: myofascial pain, Ib: myofascial pain with limited opening +/- IIIa: arthralgia and / or IIIb: osteoarthritis of the temporomandibular joint (TMJ)).
- •2) Severity of pain at diagnosis ? 4 VAS assessed by a scale of 10 cm.
- •3) Patients aged between 18 and 65 years.
- •4) Body mass index (BMI) within the normal range (19 to 30 kg / m2).
- •5) Patients who present an ASA physical status I or II (according to the classification of the American Society of Anesthesiologists - ASA).
- •6) Patients who have not participated during the three months prior to this study in a previous clinical trial.
- •7) Patients who voluntarily participate in the study and sign the 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 90
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 6
排除标准
- •1) Patients who plan to become pregnant, are pregnant and / or lactating, or not wishing to use effective contraception (hormonal contraceptives [implementation, patches, oral], and double-barrier methods [any double combination of : IUD, male or female condoms with spermicidal jelly, diaphragm, contraceptive sponge, cervical cap]).
- •2) Patients with hypersensitivity or allergy to the investigational product (PEI), or to chemically related products or placebo.
- •3)Alcohol or drug dependence history (including history of consumption of psychotropic substances) within 3 months prior to the inclusion visit.
- •4) Patients with a high consumption of stimulating beverages (> 5 coffee, tea or cola a day).
- •5) Patients who present consumption of enzyme-inducing drugs within 30 days before the study: carbamazepinam, nevirapine, phenobarbital, rifampin, secobarbital and wort
- •6) Patients who are taking paracetamol, acetylsalicylic acid, bemiparina, clonixidina, oral anticoagulants, heparin and derivatives, systemic corticosteroids, pemetresed, digoxin, phenytoin, lithium, methotrexate, salicylates, NSAIDs, antacids containing aluminum, as algeldrate, magaldrate, morphine and its derivatives.
- •Patients who have been medicated with NSAIDs or morphine derivatives for the treatment of TMD pain before attending the consultation will be included, when they meet a washout period of 8 to 12 hours (depending on the medication they have taken) before being included in the study.
- •7) Patients with underlying systemic disease candidate to receive drug treatment with analgesic.
- •8) Patients with a history of gastrointestinal bleeding or perforation related to previous treatment with NSAIDs. Peptic ulcer / active or recurrent gastrointestinal haemorrhage (two or more distinct episodes of proven ulceration or bleeding).
- •9) Patients with Crohn's disease or ulcerative colitis. Severe heart failure. Severe renal dysfunction. Severe hepatic dysfunction.
- •10) Patients with oxalate urolithiasis.
- •11) Patients with cerebrovascular bleeding or other active bleeding.
- •12) Patients with bleeding diathesis or other bleeding disorders
研究者
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