EUCTR2013-002948-91-AT进行中（未招募）不适用
A Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Naldemedine in the Treatment of Opioid-induced Constipation in Subjects with Non-malignant Chronic Pain Receiving Opioid Therapy - COMPOSE II
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 540
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. Subjects aged 18 to 80 years inclusive at the time of informed consent
- •2. Subjects must have non-malignant chronic pain treated with opioids
- •3. Subjects must be treated with a stable opioid regimen at a total daily dose on average of = 30 mg equivalents of oral morphine sulfate
- •4. Subjects must not be currently using laxatives or must be willing to discontinue laxative use at Screening and must be willing to use only the rescue laxatives provided throughout the study duration
- •5. Subjects must meet criteria based on the Bowel Movement and Constipation Assessment (BMCA) Diary
- •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 250
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 290
排除标准
- •1. Evidence of significant structural abnormalities of the gastrointestinal tract (GI)
- •2. Evidence of active medical diseases affecting bowel transit
- •3. History or presence of pelvic disorders that may be a cause of constipation
- •4. Surgery (except for minor procedures) within 60 days of Screening
- •5. History of chronic constipation prior to starting analgesic medication or any potential non-opioid cause of bowel dysfunction that may be a major contributor to the constipation (e.g., mechanical gastrointestinal obstruction)
- •6. Subjects who have never taken laxatives for the treatment of OIC
- •7. History of active treatment for cancer within the last 2 years (except for basal cell or squamous cell carcinoma of the skin that have been successfully resected) or tamoxifen [Nolvadex®] and raloxifene [Evista®] when being used for prevention of breast cancer
研究者
相似试验
进行中（未招募）
1 期
Evaluation of Dupilumab in Children with Uncontrolled Asthma (Liberty Asthma Voyage)MedDRA version: 20.0Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersAsthmaEUCTR2016-001607-23-HUSanofi-Aventis Recherche & Développement785
进行中（未招募）
1 期
Effect of Efpeglenatide on Cardiovascular OutcomesType 2 diabetes mellitusMedDRA version: 21.1Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersEUCTR2017-002954-35-FIsanofi-aventis recherche & développement5,000
进行中（未招募）
1 期
A Clinical Study to Assess the Efficacy and Safety of JNJ-63733657, an Anti-tau Monoclonal Antibody, in Participants with Early Alzheimer’s DiseaseEarly Alzheimer’s DiseaseMedDRA version: 20.0Level: LLTClassification code 10001896Term: Alzheimer's diseaseSystem Organ Class: 100000004852EUCTR2020-000116-30-SEJanssen-Cilag International NV420
进行中（未招募）
1 期
Effect of Sotagliflozin on Cardiovascular and Renal Events in Patients with Type 2 Diabetes and Moderate Renal Impairment Who Are at Cardiovascular RiskType 2 diabetes mellitusChronic kidney diseaseMedDRA version: 20.0Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersMedDRA version: 20.0Level: PTClassification code 10064848Term: Chronic kidney diseaseSystem Organ Class: 10038359 - Renal and urinary disordersEUCTR2017-002644-32-NOSANOFI-AVENTIS RECHERCHE ET DEVELOPPEMENT16,154
进行中（未招募）
1 期
GRAVITI - A Phase 3 Study to Evaluate the Efficacy and Safety of Guselkumab Subcutaneous Induction Therapy in Participants with Moderately to Severely Active Crohn’s DiseaseModerately to Severely Active Crohn's DiseaseMedDRA version: 20.0Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disordersEUCTR2020-006165-11-PLJanssen-Cilag International NV350