NL-OMON30314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 patients - Lanreotide for ileus based on peritonitis carcinomatosa
Ipsen Pharmaceuticals0 个研究点目标入组 6 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Patient having given written (personally signed and dated) 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 origin.
- •- Patient having a peritoneal carcinomatosis confirmed by a CT Scan within the previous 3 months
- •- Patient having an obstruction with at least two vomiting episodes per day or the presence of a nasogastric suction tube
- •- Patient for whom surgery is inappropriate, either documented in the medical records or confirmed by a surgical advice within the previous 72 hours
- •- Patients being treated by intra-venous corticoids since at least 5 days and intravenous proton pump inhibitors
- •- Patients having an estimated survival of more than one month
- •- Patients accepting to comply fully with the protocol.
排除标准
- •- Patient having an operable obstruction
- •- Patient having a colic obstruction (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 blockers
- •- Patient having a bowel obstruction which could be explained by a non malignant cause (e.g. 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 contraindication to intra-muscular injections
- •- Patient having a known hypersensitivity to any of the test materials or related compounds
- •- Patient having previously entered this study
- •- Patient having been included in another clinical study within the previous 30 days.
研究者
相似试验
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 patientsPatient having a high digestive obstruction of malignant origin i.e. located on the upper part of the gastro-intestinal tract (stomach, duodenum, small bowel) for whom surgery is inappropriate.EUCTR2005-002349-38-NLBeaufour Ipsen Pharma-Ipsen Biotech Department80
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