EUCTR2013-002952-34-GB进行中（未招募）1 期
A Randomised, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of Topical Alicaforsen Enema in Subjects with Active, Chronic, Antibiotic Refractory Primary Idiopathic Pouchitis - Study to compare Alicaforsen with placebo in patients with Pouchitis
Atlantic Pharmaceuticals Limited0 个研究点目标入组 138 人开始时间: 2015年10月5日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 138
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. Written informed consent;
- •2. Male or female subjects, = 18 years of age who have undergone an IPAA for UC
- •3. History of pouchitis
- •Documented evidence of active pouchitis, based on endoscopy, symptoms and histopathology, as follows:
- •4. Endoscopic score =2 on the endoscopic component of a modified MAYO score (where friability is scored as =2)
- •Note: the area within 1 cm of the pouch staple, or pouch suture line, is not considered evaluable
- •5. Symptomatic disease (stool frequency): Subjects must demonstrate increased stool frequency compared to what is considered normal” after their IPAA operation (baseline”). Stool frequency must be an absolute value of = 6 stools per day, and = 3 stools per day above the post-IPAA baseline”.
- •Note: The measurement of stool frequency will be a 7-day average rounded to the nearest integer. The most recent 7 days of data will be used to calculate the average.
- •6. Histology: evidence of disease (Score =2 on PDAI)
- •7. Overall PDAI score > 7
- •8. Must have Chronic Antibiotic Refractory Pouchitis
- •Chronic Antibiotic Refractory Pouchitis is defined as remaining in active disease despite antibiotic therapy for at least 2 continuous weeks. There is no requirement for antibiotic use to be current, or within a defined time-window. Antibiotics must be stopped 4 weeks before the Randomisation Visit which is effectively 4 weeks before the Randomisation Visit which is effectively 2 weeks before the Screening Visit. As a minimum the antibiotic regime will comprise ciprofloxacin 1g/day, or metronidazole 15 – 20 mg/kg/day. Subjects must have been in active disease for a minimum of 4 weeks at the point of randomisation.
- •OPEN LABEL ACCESS INCLUSION CRITERIA
- •1.Written informed consent;
- •2.Previous participation to Week 26 of double blind phase
- •3.Demonstrated compliance with previous alicaforsen/blinded treatment
- •4.Current evidence of active disease, based on clinical symptoms
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 69
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 69
排除标准
- •1. Lack of effective contraception
- •2. Women who are pregnant or breastfeeding;
- •3. History of allergy or adverse event to oligonucleotides including
- •alicaforsen hydroxymethylcellulose, methyl or propylparabens.
- •4. Changes in dose to strong analgesia, such as opioid containing
- •compounds within 4 weeks of the Screening Visit.
- •5. History of regular NSAID use.
- •6. Oral 5-aminosalicylate (5-ASA) compounds; exclude subjects who
- •have discontinued or changed doses of oral 5-ASA within 4 weeks of the
- •Screening Visit.
- •7. Oral budesonide > 6.0 mg / day is not permitted; exclude subjects
- •who have received budesonide for < 6 weeks, or who have changed
- •doses of budesonide within 4 weeks of the Screening Visit.
- •8. Oral steroids other than budesonide; exclude subjects who exceed a
- •daily dose of 15 mg prednisolone or equivalent, who have received oral
- •steroids for < 6 weeks, or who have changed dose within 4 weeks of the
- •Screening Visit.
- •9. Use of rectal compounds is not permitted; these agents must be
- •discontinued at the Screening Visit.
- •10. Immunosuppressant therapy (azathioprine, 6-mercaptopurine,
- •methotrexate, cyclosporin); exclude subjects who have received
- •treatment for < 12 weeks, or who have changed doses within 8 weeks of
- •the Screening Visit.
- •11. Biological agents: Anti-tumour necrosis factor (anti – TNF) therapy
- •and / or vedolizumab; are not permitted within 8 weeks of the Screening
- •12. Previous use of alicaforsen is permitted: treatment course must have
- •completed at least 12 weeks prior to the Screening Visit. (Alicaforsen
- •pre-treated subjects may not contribute to the primary efficacy
- •13. All other agents targeted to pouchitis, including experimental agents,
- •must have been discontinued at least 8 weeks prior to the Screening
- •Visit, or for a period equivalent to 5 half-lives (t½) of the agent
- •(whichever is longer)
- •14. Anastomotic stricture
- •15. Unable to undertake endoscopic evaluation
- •16. Faecal incontinence due to anal sphincter dysfunction
- •17. Infections to cytomegalovirus or Clostridium Difficile
- •18.Faecal transplantation within 12 weeks of screening
- •19. Intestinal malabsorption
- •20. Pancreatic maldigestion
- •21. Suspected irritable pouch syndrome
- •22. Cuffitis (inflammation of the anal mucosa). Subjects with active
- •antibiotic refractory pouchitis as the predominant condition, but who also have cuffitis, may be enrolled
- •23. Crohn's disease of the pouch: defined as either: a) complex perianal
- •or pouch fistula and/or b) extensive pre-pouch ileitis with deep
- •24. Subjects with a history of neoplastic disease except for basal cell
- •carcinoma or non-metastatic squamous cell carcinoma of the skin
- •25. Subjects who are receiving or have r
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Evaluation of the Safety and Efficacy of Alicaforsen Enema compared to placebo in patients with Active, Chronic, Primary Idiopathic Pouchitis which cannot be treated efficiently with antibioticsActive, Chronic, Antibiotic Refractory Primary Idiopathic PouchitisMedDRA version: 18.1Level: PTClassification code 10036463Term: PouchitisSystem Organ Class: 10017947 - Gastrointestinal disordersEUCTR2013-002952-34-NLAtlantic Pharmaceuticals Limited138