NCT00867438已完成2 期
Efficacy and Tolerability of a New Oral Extended-Release Formulation Containing Parnaparin Sodium (CB-01-05-MMX™), Administered as Add-on Therapy to Oral Mesalazine or Other 5-ASA Derivatives, in Patients With Active, Left-Sided, Mild to Moderate Ulcerative Colitis. A Multicentre Randomized, Double-Blind, Comparative Study Versus Placebo.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 133
- 主要终点
- The number of patients achieving clinical remission (CAI <4).
研究概览
简要总结
The objective of this study is to evaluate the efficacy and the tolerability of oral parnaparin sodium (210mg), administered in extended-release tablets identified as CB-01-05-MMX™.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients, between 18 and 70 years of age.
- •Patients with a confirmed diagnosis of ulcerative colitis in treatment with fixed-dose of oral mesalazine or other 5-ASA derivatives for at least 4 weeks with a high clinical suspicion of active disease, confirmed by sigmoidoscopy at enrolment in the study .
- •Presence of ulcerative colitis located at left side of the colon, from splenic flexure of the colon to the rectum (up to 15 cm proximal to the anus).
- •Patients with mild to moderate active ulcerative colitis, as defined by the DAI ≥ 4 and ≤ 10, and CAI ≥ 5 and ≤
- •Women with negative serum test for pregnancy.
- •Women of childbearing potential provided they use adequate contraceptive precautions during the treatment period. Adequate contraceptive methods are defined as those with a failure rate <1% per year when correctly used, and include implants, injectables, combined oral pills, some IUDs or a vasectomised partner in a stable relationship.
- •Ability to understand and willing to sign the Informed Consent Form, and other documents required to be read or signed by the subject.
排除标准
- •Presence of other clinically significant medical condition as determined by the Investigator.
- •History of hypersensitivity or idiosyncratic reaction to heparins.
- •History of hemorrhages, excluding intestinal bleeding due to ulcerative colitis, hemocoagulative disorders, or platelet dysfunction.
- •Presence of arterial hypertension (SAP ≥ 160 mm Hg; DAP ≥ 95 mm Hg).
- •Receipt of any investigational agent within 90 days of starting treatment.
- •Use of rectal 5-ASAs or rectal corticosteroids within 2 weeks before the starting the study.
- •Use of anti-TNF agents or immunosuppressive drugs such as azothioprine, 6-mercaptopurine or cyclosporine A in the last 3 months.
- •Patients with ulcerative colitis of severe entity (DAI > 10 or CAI > 12), or with limited distal ulcerative proctitis, or with infectious colitis confirmed by microbiological assessment in stool.
- •Patients with severe intestinal bleeding, or with Hb < 9 g/dL.
- •Presence of significant hepatic impairment (AST, ALT > 2 ULN).
- •Presence of significant renal impairment (creatinine > 2 ULN).
- •Women who are pregnant or who are breast feeding.
- •Intestinal obstruction.
- •Presence of type 1 or type 2 diabetes.
- •Concomitant oral antibiotic treatment, within 2 weeks before starting the study.
结局指标
主要结局
The number of patients achieving clinical remission (CAI <4).
时间窗: 8 weeks
次要结局
- Endoscopic Index, Histologic Score of mucosal bioptic specimens, AEs, laboratory parameters, vital signs.(8 weeks)
研究者
相似试验
进行中（未招募）
不适用
Efficacy and tolerability of a new oral extended-release formulation containing Low Molecular Weight Heparin (CB-01-05-MMX), administered as add-on therapy to oral mesalazine or other 5-ASA derivatives, in patients with active, left-sided, mild to moderate ulcerative colitis. A multicentre randomized, double-blind, comparative study versus placebo.Active left-sided, mild to moderate ulcerative colitisMedDRA version: 8.1Level: LLTClassification code 10045365Term: Ulcerative colitisEUCTR2006-001782-42-HUCosmo Technologies Ltd120
进行中（未招募）
1 期
Efficacy and tolerability of a new oral extended-release formulation containing Low Molecular Weight Heparin (CB-01-05-MMX), administered as add-on therapy to oral mesalazine or other 5-ASA derivatives, in patients with active, left-sided, mild to moderate ulcerative colitis. A multicentre randomized, double-blind, comparative study versus placebo.EUCTR2006-001782-42-GBCosmo Technologies Ltd120
进行中（未招募）
不适用
Efficacy and tolerability of a new oral extended-release formulation containing Low Molecular Weight Heparin CB-01-05-MMXTM , administered as add-on therapy to oral mesalazine or other 5-ASA derivatives, in patients with active, left-sided, mild to moderate ulcerative colitis. A multicentre randomized, double-blind, comparative study versus placebo. - NDEUCTR2006-001782-42-ITCOSMO TECHNOLOGIES LTD120
已完成
1 期
A First In Human Study Of PF-00184562 In Healthy VolunteersSchizophreniaNCT00150215Pfizer18
终止
不适用
Oral Propionate to Treat and Prevent DiabetesDiabetes MellitusNCT01692002Imperial College London6