EUCTR2009-014870-16-HU进行中（未招募）不适用
A phase II, multicentre, randomised, double-blind, placebo-controlled study comparing the efficacy and safety of Clonidine Lauriad™ 50 µg and 100 µg mucoadhesive buccal tablet (MBT) applied once daily to those of placebo in the prevention and treatment of chemoradiation therapy induced oral mucositis in patients with head and neck cancer
BioAlliance Pharma0 个研究点目标入组 183 人开始时间: 2012年7月23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
- 183
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.Male or female
- •2.Aged >18 years
- •3.Suffering from a newly diagnosed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx histologically-confirmed and having undergone resective surgery
- •4.Prior neoadjuvant chemotherapy allowed provided that, the patient did not experience a WHO grade > 2 oral mucositis during the neoadjuvant therapy.
- •5.Patient eligible to receive concurrent chemo-radiation defined as :
- •a.A continuous course of conventional external beam irradiation (IMRT eligible) with a minimum cumulative radiation dose of 50 Gy and a maximum of 70 Gy, based on a daily dosing between 1.8 and 2.2 Gy combined with platinum based chemotherapy on a weekly or tri-weekly cycles
- •b.Planned radiation treatment fields must include at least two oral tissue sites (among right or left buccal mucosa, floor of the mouth, tongue, right or left soft palate) with each site receiving a total of 50 Gy or a maximum of 70 Gy. The radiation treatment plan will be reviewed by a designated radiation oncologist.
- •6.ECOG performance status = 2
- •7.Screening laboratory tests
- •a.Haemoglobin = 10g/dL (100 g/L)
- •b.Absolute neutrophil counts = 1500 cells/mm3 (1.5 109 cells/L)
- •c.Platelets = 100.000/mm3 (100 109/L)
- •d.Conjugated bilirubin = 2 times Upper Limit of Normal (ULN)
- •e.Serum AST and ALT = 3 ULN
- •f.Negative serum pregnancy test
- •8.Women of child bearing potential must have effective contraception method (oral or device)
- •9.Signed written informed consent
- •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 160
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 23
排除标准
- •1.Tumours of the lips, sinuses, salivary glands
- •2.Prior radiation of the head and neck area
- •3.Curative surgery less than 2 weeks or more than 15 weeks prior to the initiation of RT-CT
- •4.Presence of active infectious disease
- •5.Presence of active oral infectious disease, including oropharyngeal candidiasis and/or orofacial herpes
- •6.Presence of oral mucositis
- •7.Known or suspected chronic viral diseases including HIV
- •8.Systolic blood pressure <100 mmHg and/or diastolic blood pressure <50 mmHg
- •9.Recent stroke within the last 6 months
- •10.Bradyarrhythmia (< 60 b/min), including sinus node dysfunction or AV nodal conduction block 2nd or 3rd degree.
- •11.Subjects with orthostatic hypotension, defined by a decrease of systolic BP and/or diastolic BP above 20 mmHg when the patient stands up
- •12.Renal insufficiency defined as creatinine blood level > 1.5ULN
- •13.Ongoing heavy alcohol consumption (>100g alcohol/day)
- •14.Administration of any concomitant treatment likely to interfere with clonidine (see section 6.4)
- •15.Known hypersensitivity to clonidine, history of allergy or intolerance to milk proteins or any other component of the product
- •16.Presence of severe or uncontrolled depression
- •17.Pregnant or breast-feeding women
- •18.Inability to give informed consent or comply with study requirements
- •19.Unable or unwilling to comply with follow-up visits
- •20.Participation to a clinical trial within 30 days prior to randomization and during the entire duration of the study
研究者
相似试验
进行中（未招募）
不适用
A study to assess safety and effectiveness of the study drug MT-1303 at different dosage strengthsEUCTR2012-002470-31-BEMitsubishi Tanabe Pharma Corporation (MTPC)400
进行中（未招募）
不适用
A study to assess safety and effectiveness of the study drug MT-1303 at different dosage strengthsEUCTR2012-002470-31-ESMitsubishi Tanabe Pharma Corporation (MTPC)400
进行中（未招募）
不适用
A study to assess safety and effectiveness of the study drug MT-1303 at different dosage strengthsEUCTR2012-002470-31-ITMITSUBISHI PHARMA CORPORATIO400
进行中（未招募）
不适用
A study to assess safety and effectiveness of the study drug MT-1303 at different dosage strengthsRelapsing-Remitting Multiple SclerosisMedDRA version: 14.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersEUCTR2012-002470-31-HUMitsubishi Tanabe Pharma Corporation (MTPC)400
进行中（未招募）
1 期
A clinical study to evaluate the efficacy of a drug (CHF 5993) comparing the results obtained with two different pharmaceutical forms and the effects produced by another drug (CHF 1535), in patients with chronic obstructive pulmonary diseasechronic obstructive pulmonary disease (COPD)MedDRA version: 20.0Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 100000004855EUCTR2017-004405-41-PLChiesi Farmaceutici S.p.A.366