EUCTR2009-009936-56-FR进行中（未招募）1 期
Randomized, double-blind, placebo and active controlled study of the activity ofSAR407899A single-dose on the ability to increase duration of penile rigidity,under experimental condition, in patients with mild to moderate erectiledysfunction - RHOKET
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 24
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
- Male
入选标准
- •- Male patient with history of mild to moderate erectile dysfunction =6 months according to the National Institutes of Health Consensus Statement definition
- •- Having given written informed consent prior to any procedure related to the study.
- •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
- •Related to study methodology at screening :
- •-Age <18 years or >60 years
- •-Patient without a self-reported erection under visual sexual simulation in the past 6 months
- •-Vital signs at screening outside the following range, after 10 min resting in supine
- •100 mmHg• 45 mmHg• 40 bpm-Abnormal standard 12-lead ECG after 10 min resting in supine position at screening;
- •120 ms-Laboratory parameters outside the normal range unless the Investigator considers an abnormality as clinically not relevant for these patients. Hepatic enzymes (AST, ALT) should be strictly below 3 upper laboratory norms.
- •-Any clinical penile abnormality that does not allow proper fit of the RigiScan® Plus
- •-Contact dermatitis
- •-Non responders to PDE5 inhibitor(s): defined as less than 50% of successful attempts for at least 6 months
- •-History of radical prostatectomy
- •-Diabetes mellitus
- •-Hypogonadal testosterone levels (<300 ng/dl)
- •-TSH levels <0.30 µU/ml or >5.30 µU/ml
- •-Any history or presence of clinically relevant cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, hematological, neurological, psychiatric, systemic, testicular, ocular or infectious disease, any acute infectious disease or signs of acute illness
- •-Any treatment for depression, psychiatric disorders, substance abuse, anxiety disorders, investigational drug within 3 months prior to inclusion
- •-Nitrates, Nitric Oxide donors, androgens or beta-androgens, trazodone
- •-Beta blockers for hypertension or other chronic medical condition are authorized if dose has been stable for at least 1 month prior to screening for the study and use has not been associated with orthostatic symptoms and blood pressure is stable.
- •Additional exclusion criteria related to study methodology at randomization visit :
- •-Positive reaction to any of the following tests: hepatitis B surface (HBs) antigen,
- •anti-hepatitis C virus (anti-HCV) antibodies, anti-human immunodeficiency virus (HIV) 1 antibodies, anti-HIV2 antibodies
- •-Positive results on urine drug screen (amphetamines/methamphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates)
- •-Positive alcohol breath test (as an indication of alcohol use)
- •Exclusion criteria related to SAR407889A :
- •-Any history of severe orthostatic dysregulation (neurocardiogenic syncope, postural
- •orthostatic tachycardia syndrome)
- •-Patients with partners of childbearing potential or whose partners are pregnant or lactating or not willing to use an effective method of contraception during the study and for 7 weeks after the end of study visit (eg, condom associated with spermicide plus occlusive cap).
- •Exclusion criteria related to sildenafil :
- •-Hypersensitivity to PDE5 inhibitor
- •-Men with cardiac disease for whom sexual activity is inadvisable
- •-Patients with myocardial infarction within the last 90 days
- •-Patients with unstable angina or angina occurring during sexual intercourse
- •-Patients with New York Heart Association Class 2 or greater heart failure in the last
- •-Patients with uncontrolled arrhythmias, hypotension (<90/50 mm Hg), or uncontrolled hypertension
- •-Patients with a stroke within the last 6 months
- •-Loss of vision in one eye because of non-arteritic anterior ischemic optic neuropathy
- •(NAION), regardless of whether this episode was in connection or not with previous
- •PDE5 inhibitor exposure
- •-Use of an alpha-1 blocker
研究者
相似试验
进行中（未招募）
不适用
Double-blind, randomised, placebo and active controlled, parallel group study to evaluate the analgesic effect of a single oral administration of four different combination doses of DKP.TRIS with TRAM.HCl in comparison with the single agents, on moderate to severe pain following impacted third mandibular molar tooth extraction - NDModerate to severe pain following impacted third mandibular molar tooth extraction.MedDRA version: 9.1Level: LLTClassification code 10044017EUCTR2010-022798-32-ITMENARINI RICERCHE S.P.A.600
暂停
不适用
Safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) study with ENX-201Multiple Sclerosis (relapses)NL-OMON23997EnhanX Biopharm Inc.12
进行中（未招募）
不适用
Clinical trial to evaluate the clinical effect and safety of a triple combination of ibuprofen, magnesium and vitamin C in the treatment of acute pain in temporomandibular disorders (TMD).Temporomandibular joint dysfunction syndrome.EUCTR2014-003790-41-ESSpherium Biomed
进行中（未招募）
不适用
Randomized, Double-Blind, Active- and Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Multiple Doses of CG5503 Immediate Release Formulation in the Treatment of Acute Pain From Total Hip Replacement Surgery Followed by a Voluntary Open-Label ExtensionEstudio aleatorizado, en doble ciego, controlado con producto activo y con placebo, de grupos paralelos y multicéntrico, para evaluar la eficacia y la seguridad de distintas dosis de CG5503 en formulación de liberación inmediata en el tratamiento del dolor agudo consecuencia de la cirugía de artroplastia total de cadera, seguido por una extensión abierta de carácter voluntariopainMedDRA version: 8.1Level: LLTClassification code 10033371Term: PainEUCTR2006-004513-18-ESJohnson & Johnson Pharmaceutical Research & Development, L.L.C.1,100
进行中（未招募）
1 期
Randomized, Double-Blind, Active- and Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Multiple Doses of CG5503 Immediate Release Formulation in the Treatment of Acute Pain From Total Hip Replacement Surgery Followed by a Voluntary Open-Label ExtensiopainMedDRA version: 8.1Level: LLTClassification code 10033371Term: PainEUCTR2006-004513-18-FRJohnson & Johnson Pharmaceutical Research & Development, L.L.C.