EUCTR2005-002349-38-NL进行中（未招募）不适用
Phase III multicentre, Randomised, Double Blind, Comparative study to assess the efficacy and safety of lanreotide 30mg versus placebo as a palliative treatment of clinical symptoms associated with intestinal obstruction due to peritoneal carcinomatosis in inoperable patients
Beaufour Ipsen Pharma-Ipsen Biotech Department0 个研究点目标入组 80 人开始时间: 2006年12月22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
- 入组人数
- 80
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
- •Patient having given a written informed consent before completing any study-related procedure,
- •Patient being over 18 years of age,
- •Patient having a high digestive obstruction i.e. located on the upper part of the gastro-intestinal tract (stomach, duodenum, small bowel) ,
- •Patient having a digestive obstruction of malignant origin1,
- •Patient having peritoneal carcinomatosis confirmed by a CT Scan within the previous 3 months1,
- •Patient having an obstruction with at least two vomiting episodes per day or the presence of a nasogastric suction tube1,
- •Patient for whom surgery is inappropriate, either documented in the medical records or confirmed by a surgical advice within the previous 72 hours1,
- •Patient being treated by intra-venous corticoids since at least 5 days and intra-venous proton pump inhibitors,
- •Patient having an estimated survival of more than one month,
- •Patient accepting to comply fully with the protocol.
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patient having an operable obstruction1,
- •Patient having a colic obstruction1 (must be documented by an abdominal X-Ray within the previous 3 days),
- •Patient having received any specific anticancer therapy within the previous 15 days,
- •Patient receiving any antiH2 receptor blockers1,
- •Patient having a bowel obstruction which could be explained by a non malignant cause (hypokaliaemia, drug side-effects, renal insufficiency,..),
- •Patient having signs of bowel perforation,
- •Patient having received somatostatin or any analogue as treatment of the bowel obstruction,
- •Patient having a contra-indication to intra-muscular injections,
研究者
相似试验
尚未招募
3 期
Phase III multicentre, Randomised, Double Blind, Comparative study to assess the efficacy and safety of lanreotide 30mg versus placebo as a palliative treatment of clinical symptoms associated with intestinal obstruction due to peritoneal carcinomatosis in inoperable patientsperitoneal carcinomatosis1001800810017991intestinal obstructionNL-OMON30314Ipsen Pharmaceuticals6
招募中
1 期
A Phase 3, Multicentre, Randomised, Double-blind, Vehicle-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Tirbanibulin 10 mg/g Ointment Applied to a Treatment Field Larger Than 25 cm2 and up to 100 cm2 in Adult Patients With Actinic KeratosisActinic Keratosis on the Face or ScalpMedDRA version: 20.0Level: PTClassification code: 10000614Term: Actinic keratosis Class: 100000004858CTIS2023-505487-11-00Almirall S.A.270
进行中（未招募）
1 期
A study to compare the effet of HLX02 and Herceptin® in Breast CancerPreviously Untreated Overexpressing metastasic breast cancerMedDRA version: 20.0Level: PTClassification code 10065430Term: HER-2 positive breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2016-000206-10-PLShanghai Henlius Biotech Inc.608
进行中（未招募）
1 期
A Phase 3, Randomised, Double-blind, Multicentre, Parallel-group, Placebo- and Active-reference, Dose-optimisation Efficacy and Safety Study of Extended-release Guanfacine Hydrochloride in Children and Adolescents aged 6 17 years with Attention-Deficit/Hyperactivity DisorderEstudio de fase 3, multicéntrico, aleatorizado, doble ciego, en grupos paralelos, con referencia activa y placebo, de la eficacia y seguridad de la optimización de dosis de clorhidrato de guanfacina de liberación prolongada en niños y adolescentes de 6 a 17 años con Trastorno por Déficit de Atención con HiperactividadAttention-Deficit/Hyperactivity Disorder (ADHD)Trastorno por déficit de atención con hiperactividadMedDRA version: 12.1Level: LLTClassification code 10068451Term: ADHD, combined typeMedDRA version: 12.1Level: LLTClassification code 10068452Term: ADHD, predominantly hyperactive-impulsive typeMedDRA version: 12.1Level: LLTClassification code 10068453Term: ADHD, predominantly inattentive typeMedDRA version: 12.1Level: LLTClassification code 10064104Term: ADHDEUCTR2010-018579-12-ESShire Pharmaceutical Development Ltd338
进行中（未招募）
不适用
Study to assess the safety and efficacy of Guanfacine-Hydrochloride in Children and Adolescents aged 6-17 years old, with Attention-Deficit/Hyperactivity DisorderAttention-Deficit/Hyperactivity Disorder (ADHD)MedDRA version: 15.0Level: LLTClassification code 10068451Term: ADHD, combined typeSystem Organ Class: 10037175 - Psychiatric disordersMedDRA version: 15.0Level: LLTClassification code 10068453Term: ADHD, predominantly inattentive typeSystem Organ Class: 10037175 - Psychiatric disordersMedDRA version: 15.0Level: LLTClassification code 10068452Term: ADHD, predominantly hyperactive-impulsive typeSystem Organ Class: 10037175 - Psychiatric disordersMedDRA version: 15.0Level: LLTClassification code 10064104Term: ADHDSystem Organ Class: 10037175 - Psychiatric disordersEUCTR2010-018579-12-ATShire Pharmaceutical Development Ltd333