EUCTR2013-001744-65-HU进行中（未招募）1 期
A Phase 3, Multicenter, Randomized, Double-blind Study to Determine the Safety and Efficacy of MMX Mesalamine/Mesalazine in Paediatric Subjects with Mild to Moderate Ulcerative Colitis, in both Acute and Maintenance Phases
Shire Devlopment LLC0 个研究点目标入组 107 人开始时间: 2014年7月15日最近更新:
适应症
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
- 107
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. Ability to voluntarily provide written, signed, and dated (personally or via a LAR) informed consent or assent as applicable to participate in the study.
- •2. Subject’s parent/LAR demonstrates an understanding, ability, and willingness to fully comply with study procedures and restrictions.
- •3. Male and female children and adolescents aged 5-17 years, inclusive, at the Baseline Visit (Visit 2).
- •4. Body weight 18-90 kg at the Screening Visit (Visit 1) and the Baseline Visit (Visit 2).
- •5. Male, or non-pregnant, non-lactating female who agrees to comply with any applicable contraceptive requirements of the protocol or females of non-childbearing potential.
- •6. Diagnosed with mild to moderate UC, established by sigmoidoscopy or colonoscopy with compatible histology. Screened subjects may also have an unconfirmed diagnosis of mild to moderate UC; however the diagnosis of mild to moderate UC must have been established by sigmoidoscopy or colonoscopy with compatible histology prior to the Baseline Visit (Visit 2).
- •7. Subject is able to swallow the investigational product whole.
- •Double-blind Acute Phase:
- •8. Partial UC-DAI score =2 (a combined rectal bleeding and stool frequency score =1 and PGA=1 or 2) at the Baseline Visit (Visit 2), for which 5-ASA would be used as part of normal treatment.
- •9. If the subject is on 5-ASA treatment prior to study entry, then the dose must be stable. Stable therapy is defined as no change in dose, or no initiation of 5-ASA, from the onset of the current acute flare through discontinuation of therapy (required at the Baseline Visit; Visit 2). See exclusion criterion 29 for an additional 5-ASA dose-related requirement.
- •Double-blind Maintenance Phase:
- •10. Partial UC-DAI =1 (rectal bleeding=0, stool frequency =1, and PGA=0) at the Baseline Visit (Visit 2).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 128
- •F.1.2 Adults (18-64 years) no
- •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. Severe UC (defined by PGA=3) at the Baseline Visit (Visit 2).
- •2. Crohn’s disease, bleeding disorders, active peptic ulcer disease, or UC known to be confined to the rectum (isolated rectal proctitis).
- •3. Asthma, only if known to be 5-ASA sensitive.
- •4. Positive stool culture for enteric pathogens (including Salmonella, Shigella, Yersina, Aeromonas, Plesiomonas, or Campylobacter). Clostridium difficile toxin, ova, or parasites present.
- •5. Previous colonic surgery.
- •6. Any history of hepatic impairment, in the opinion of the investigator.
- •7. Moderate to severe renal impairment, in the opinion of the investigator
- •8. Immediate or significant risk of toxic megacolon, in the opinion of the investigator.
- •9. History of pancreatitis.
- •10. History of Reyes syndrome.
- •11. Systemic or rectal corticosteroid use within 4 weeks prior to the Screening Visit (Visit 1). Topical, intranasal, or inhaled use is not exclusionary.
- •12. Immunomodulator (eg, 6-mercaptopurine, azathioprine) use within 6 weeks prior to the Screening Visit (Visit 1).
- •13. History of biologic (eg, anti-tumor necrosis factor agents, integrin receptor antagonists) within 1 year prior to the Screening Visit (Visit 1).
- •14. Antibiotic use within 7 days prior to the Screening Visit (Visit 1).
- •15. Any anti-inflammatory drugs, not including 5-ASA treatment but including non-steroidal anti-inflammatory drugs such as aspirin, COX-2 inhibitors or ibuprofen, within 7 days prior to the Screening Visit (Visit 1) unless used at over the counter levels for <3 days. However, prophylactic use of a stable dose of aspirin up to 325 mg/day for cardiac disease is permitted.
- •16. Oral anticoagulant use (with the exception of subjects who have been on a stable dose of Vitamin K antagonists such as warfarin for at least 90 days prior to the Screening Visit [Visit 1] and who are medically stable).
- •17. Treatment with anti-diarrheals and/or anti-spasmodics within 3 days prior to the Screening Visit (Visit 1).
- •18. Vaccination/immunization within 14 days prior to the Screening Visit (Visit 1).
- •19. Predisposed to the development of myo- or pericarditis.
- •20. Previously screened or randomized into this study and withdrawn. Exception may be made and subject may be re-screened if principal investigator or central endoscopy reader determines that bowel preparation for the eligibility endoscopy is inadequate to assign a mucosal healing score and a repeat endoscopy could not be performed during the period of the Screening Visit.
- •21. Current or recurrent disease that could affect the action, absorption, or disposition of the investigational product, or could affect clinical or laboratory assessments.
- •22. Current or relevant history of physical or psychiatric illness, any medical disorder that may require treatment, including surgery, or make the subject unlikely to fully complete the study, or any condition that presents undue risk from the investigational product or procedures.
- •23. Current use of any medication (including over the counter, herbal, or homeopathic preparations) that could affect (improve or worsen) the condition being studied, or could affect the action, absorption, or disposition of the investigational product(s), or clinical or laboratory assessment. (Current use is defined as use within 14 days of the Screening Visit [Visit 1].) See Section 5 (Prior and Concomitant Treatment) for a list of prohibited and restricted medications.
- •24. Known or suspected intolerance or hypersensitivity to the investigational
研究者
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