EUCTR2021-001465-20-ES进行中（未招募）1 期
A double-blind, multicenter, randomized clinical trial to assess the efficacy and safety ofMontelukast in patients with erosive / inflammatory arthrosis of the hands
aboratorios Farmalíder S.A.0 个研究点目标入组 280 人开始时间: 2021年10月19日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 280
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 who give their written informed consent and are willing to comply with all the visits and planned procedures required by the study
- •2. Patients = 18 years old at the time of the screening visit
- •3. Patients with erosive arthritis of the interphalangeal joints of the hand with significant clinical activity according to Anandarajah (Anandarajah, A. 2010) criteria
- •4. Patients with a pain = 50 mm in the VAS at the baseline visit
- •5. Patients with functional consequence despite the conventional treatment
- •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 196
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 84
排除标准
- •Related to medical history
- •1. History of active malignant neoplasm of any type or with a history of malignant neoplasm in the last five years
- •2. History of fibromyalgia and/or chronic fatigue syndrome
- •3. History of myocardial infarction or stroke, or who have experienced chest pain related to a heart disease, or who have suffered from severe heart disease
- •4. History of concurrent rheumatic joint disease (history and/or current presence of signs) that could lead to misinterpretation or interfere with the assessment
- •5. Pain in other parts of the body that is more intense than the hand pain and that could interfere with the assessment and the study results.
- •6. Patients with poorly controlled AHT (maintained systolic blood pressure >150mm Hg or maintained diastolic blood pressure >95mm Hg)
- •7. Patients with poorly controlled diabetes mellitus, defined by a Hemoglobin A1c level >8%
- •8. History of immunosuppression
- •9. Hepatitis B surface antigen (HBsAg) test result or positive antibody to Hepatitis C
- •10. Patients with acute or chronic active infections requiring antimicrobial treatment or severe fungal or viral infections
- •11. Patients with a significant coagulation defect
- •12. Patients who have been diagnosed with esophageal, gastric, pyloric, or duodenal ulcers, or who have received treatment for them within 30 days prior to the screening visit
- •13. Patients with chronic liver disease defined by AST o ALT 2 times upper limit of normal
- •14. Patients with chronic kidney disease with blood urea nitrogen (BUN) or serum creatinine levels 2 times the ULN or Clcr<30 ml/minute at the screening visit
- •15. History of significant medical conditions, which in the opinion of the investigator, would exclude the patient from participating in this clinical trial
- •Related to the investigational medicinal product
- •1. Patients taking corticosteroids (oral or injectable), methotrexate, hydroxychloroquine or SYDADOA (slow-acting drugs for the symptomatic treatment of osteoarthritis) in the 12 weeks prior to the screening visit
- •2. Patients who have used intra-articular hyaluronic acid (in the study hand) during the 24 weeks prior to the screening visit
- •3. Patients undergoing radioactive synoviorthesis (in the study hand)
- •4. Patients who have received any live virus vaccine during the 12 weeks prior to the screening visit (also not allowed during the clinical trial, including 3 months after the last dose of study medication)
- •5. Patients under treatment with other disease-modifying antirheumatic biologic drugs
- •6. Patients under treatment with oral anticoagulants
- •7. Patients under treatment with any other medication that should not be administered due to the risk of adverse interactions with the study medication listed in the protocol
- •8. Patients who have used paracetamol or other analgesics and/or NSAIDs during the 15 days prior to the start of study treatment
- •9. Patients with a history of allergy or hypersensitivity to the study medication, rescue medication or any of its excipients
- •10. Patients with intolerance to study medication due to galactose intolerance, lactase insufficiency or glucose or galactose malabsorption
- •11. Patients with a history of known hypersensitivity to sulfonamides
- •12. Active peptic ulcer, NSAID gastrointestinal disorders, active gastrointestinal bleeding or history of gastrointestinal bleeding
- •13. Patients with a history of asthma, urticaria, acute rhinitis, angioneurotic edema or any other allergic reaction after administ
研究者
相似试验
招募中
不适用
Clinical trial to evaluate the efficacy and safety of GUGUTAMS capsuleDiseases of The genitoruinary systemKCT0002940Kangdong Sacred Heart Hospital404
进行中（未招募）
1 期
A multicenter, randomized, double-blind clinical study to examine the efficacy and safety of Zarzenda® in comparison to Elidel® in the management of mild to moderate atopic dermatitis in children and adolescents.Estudio clínico multicéntrico, aleatorizado y en doble ciego para examinar la eficacia y la seguridad de Zarzenda® en comparación con Elidel® en el tratamiento de la dermatitis atópica leve a moderada en niños y adolescentes.EUCTR2007-002133-36-ESINTENDIS GmbH80
进行中（未招募）
不适用
A multicenter, randomized, double-blind clinical study to examine the efficacy and safety of Zarzenda® in comparison to Elidel® in the management of mild to moderate atopic dermatitis in children and adolescents.EUCTR2007-002133-36-DEINTENDIS GmbH80
进行中（未招募）
不适用
Clinical study to assess the efficacy and safety of Ciprofloxacin plus Fluocinolone otic solution compared to Ciprofloxacin otic solution and to Fluocinolone Otic solution in the treatment of ear infection in pediatric patients with tympanostomy tubes.Acute Otitis Media with Tympanostomy Tubes (AOMT) in Pediatric PatientsMedDRA version: 14.1Level: PTClassification code 10033079Term: Otitis media acuteSystem Organ Class: 10021881 - Infections and infestationsEUCTR2010-023239-40-SEaboratorios SALVAT, S.A.330
进行中（未招募）
不适用
Clinical study to assess the efficacy and safety of Ciprofloxacin plus Fluocinolone otic solution compared to Ciprofloxacin otic solution and to Fluocinolone Otic solution in the treatment of ear infection in pediatric patients with tympanostomy tubes.Acute Otitis Media with Tympanostomy Tubes (AOMT) in Pediatric PatientsMedDRA version: 14.1Level: PTClassification code 10033079Term: Otitis media acuteSystem Organ Class: 10021881 - Infections and infestationsEUCTR2010-023239-40-FIaboratorios SALVAT, S.A.330