EUCTR2008-004610-27-SK进行中（未招募）1 期
A double-blind, randomised, placebo and mesalazine controlled phase II study to explore the safety and activity of dersalazine in patients with mild to moderate active colitis
Palau Pharma S.A.0 个研究点目标入组 90 人开始时间: 2009年2月9日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 90
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. Aged 18 to 65 years inclusive.
- •2. Patient is male or, if the patient is female, she is eligible to enter the study if she is of:
- •- Non-childbearing potential (i.e. physiologically incapable of becoming pregnant, including any female who has undergone sterilization or is post menopausal [1 year without menstruation])
- •Child-bearing potential with the following restrictions:
- •- All females of child-bearing potential must have a negative serum pregnancy test immediately prior to enrolment
- •- All females of child-bearing potential, if heterosexually active, must be using an accepted form of contraception throughout the entire study period and for 1 monthly cycle following completion of the study. Accepted forms of contraception are defined as any hormonal contraception (for at least 2 monthly cycles prior to the start of the study), use of an intra-uterine device or male sterilisation plus usage by at least one of hte partners of an additional spermicidal-containing barrier method of contraception (condom or occlusive cap (diaphragm or cervical/vault caps)). The use of one contraception method alone or abstinence during the study period is not considered adequate.
- •3. A confirmed diagnosis of UC by endoscopy evaluation 3 months prior to entry into the study.
- •4. Disease extends at least 20 cm from the rectum on screening sigmoidoscopy.
- •5. Active UC as defined by a score between 5 and 10 inclusive in the Mayo score.
- •6. An endoscopy (flexible sigmoidoscopy) sub-score of at least 2 on the Mayo score determined within 10 days or less prior to first dosing.
- •7. Able to communicate well with the investigator and research staff and to comply with the requirements of the entire study.
- •8. Provision of written informed consent to participate in the study as shown by a signature on the patient consent form.
- •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
- •1. Patient has a significant medical condition, including psychiatric, which in the opinion of the investigator precludes participation in the study.
- •2. Patient has a history of allergy or intolerance to aspirin, mesalazine or other salicylates.
- •3. Patient has a faecal culture indicating the presence of pathogenic infection.
- •4. Patient has received immunosuppressive therapy (e.g. azathioprine, cyclosporine or mercaptopurine) within the last 90 days prior to screening.
- •5. Patient has received methotrexate within the last 90 days prior to screening.
- •6. Patient has received oral or i.v. corticosteroids within the last 30 days prior to screening (inhaled steroids are permitted).
- •7. Patient has been treated with biological therapy (e.g. infliximab, adalimumab, or natalizumab) within the last 90 days prior to screening.
- •8. Patient has received intra-rectal aminosalicilates or corticosteroirds within the last 14 days prior to screening.
- •9. Patient has received repeated treatment (more than 3 days) with non-steroidal anti-inflammatory drugs within the last 7 days prior to screening.
- •10. Patient has received antibiotics within the previous 14 days prior to screening.
- •11. Patient has participated in any investigational drug or device study within the 90 days prior to study screening.
- •12. Patient is pregnant, at risk of pregnancy, or is lactating.
- •13. Patient shows evidence of current excessive alcohol consumption or drug dependence in the opinion of the investigator.
- •14. Patient is unable to give his/her informed consent.
- •15. Patient is known to be positive for human immunodeficiency virus, hepatitis B virus, or hepatitis C virus.
- •16. Patient has other infectious, ischemic or immunologic disease.
- •17. Patient has values that are 2x ULN or greater for any of the following parameters: alanine aminotransferase (ALT/GOT), gamma glutamyl transferase (GGT), aspartate aminotransferase (AST/GPT), alkaline phosphatase (ALP) or total bilirubin (except isolated elevation or unconjugated bilirubin).
- •18. Patient has uncontrolled, clinically significant renal disease manifested by values that are 2x ULN or greater of serum creatinine or blood urea nitrogen (BUN) levels.
- •19. Patient has unstable cardiovascular disease (NYHA class III & IV coagulopathy or hypercoagulable state pulmonary disease - see protocol Appendix C for details).
- •20. Patient has any condition or circumstance that would, in the opinion of the investigator, prevent completion of the study or interfere with analysis of study results, including history of non-compliance with treatments or visits.
研究者
相似试验
进行中（未招募）
不适用
A double-blind, randomised, placebo and mesalazine controlled phase II study to explore the safety and activity of dersalazine in patients with mild to moderate active colitisMild to moderate active ulcerative colitisMedDRA version: 9.1Level: LLTClassification code 10045365Term: Ulcerative colitisEUCTR2008-004610-27-BEPalau Pharma S.A.90
进行中（未招募）
不适用
A double-blind, randomised, placebo and mesalazine controlled phase II study to explore the safety and activity of dersalazine in patients with mild to moderate active colitisMild to moderate active ulcerative colitisMedDRA version: 9.1Level: LLTClassification code 10045365Term: Ulcerative colitisEUCTR2008-004610-27-HUPalau Pharma S.A.90
进行中（未招募）
1 期
A randomised, double-blind, placebo- and olanzapine- controlled, parallel-group study to evaluate the efficacy and safety of 3 fixed doses of S 33138 in treatment of patients with an acute episode of Schizophrenia. A phase IIb, international, multicentre, 8-week studyMedDRA version: 10.0Level: LLTClassification code 10039626Term: <Manually entered code. Term in E.1.1>SchizophreniaEUCTR2006-006184-23-SKInstitut de Recherches Internationales Servier
尚未招募
2 期
An investigation into the tolerability of Manuka Cyclopower (trademark)ACTRN12613000766718Manuka Health NZ Ltd64
已完成
不适用
DRIVE - Desmopressin for procedures or radiological interventionsISRCTN12845429HS Blood and Transplant40