EUCTR2013-001744-65-NL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8月7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
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 18-90kg 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.
- •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)
- •use at any time.
- •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 325mg/day for
- •cardiac disease is permitted.
- •16. Prebiotic/probiotic use within 7 days prior to the Screening Visit (Visit 1). Yogurt
- •products are permitted.
- •17. 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).
- •18. Treatment with anti-diarrheals and/or anti-spasmodics within 3 days prior to the
- •Screening Visit (Visit 1).
- •19. Vaccination/immunization within 14 days prior to the Screening Visit (Visit 1).
- •20. Predisposed to the development of myo- or pericarditis.
- •21. Previously been screened or randomized into this study and withdrawn.
- •22. Current or recurrent disease that could affect the action, absorption, or disposition of the
- •investigational product, or could affect clinical or laboratory assessments.
- •23. 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.
- •24. Current use of any medication (including over the counter, herbal, o
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