NL-OMON44753招募中3 期
A Phase 3, Multicenter, Randomized, Double-blind Study to Determine the Safety and Efficacy of MMX Mesalamine/Mesalazine in Pediatric Subjects with Mild to Moderate Ulcerative Colitis, in both Acute and Maintenance Phases - Study of MMX® Mesalamine/Mesalazine in Paediatric Ulcerative Colitis
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 16
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 17（—）
入选标准
- •1. Ability to voluntarily provide written, signed, and dated (personally or via a legally authorized representative [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.
- •Doubleblind Acute Phase:
- •8. Partial UCDAI
- •score >=2 (a combined rectal bleeding and stool frequency score >=1 and PGA=1 or 2) at the Baseline Visit (Visit 2), for which 5ASA would be used as part of normal treatment.
- •9. If the subject is on 5ASA treatment prior to study entry, then the dose must be stable. Stable therapy is defined as no change in dose, or no initiation of 5ASA, from the onset of the current acute flare through discontinuation of therapy (required at the Baseline Visit [Visit 2]). Please see exclusion criterion 29 for an additional 5ASA dose related requirement.
- •Doubleblind Maintenance Phase:
- •10. Partial UCDAI <=1 (rectal bleeding=0, stool frequency <=1 and PGA=0) at the Baseline Visit (Visit 2).
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 (6mercaptopurine, azathioprine) use within 6 weeks prior to the Screening
- •Visit (Visit 1).
- •13. History of biologic (e.g., antitumor necrosis factor agents, integrin receptor antagonists) use at
- •14. Antibiotic use within 7 days prior to the Screening Visit (Visit 1).
- •15. Any anti-inflammatory drugs, not including 5ASA treatment but including non-steroidal
- •anti-inflammatory drugs such as aspirin, COX2 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
- •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 antidiarrheals and/or antispasmodics 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 effect 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, 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].)
- •25. Known or suspected intolerance or hypersensitivity to the investigational product(s) (aminosalicylates [5 ASA]), closely related compounds (including but not limited to salicylates), or any of the stated ingredients.
- •26. Known history of alcohol
研究者
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