EUCTR2013-002952-34-NL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
Atlantic Pharmaceuticals Limited0 个研究点目标入组 138 人开始时间: 2015年11月19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
- 性别
- All
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 2 weeks before the Screening Visit. As a minimum the antibiotic regime will comprise ciprofloxacin 1g/day, or metronidazole 15 – 20 mg/kg/day. Patients must have been in active disease for a minimum of 4 weeks at the point of randomisation.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •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 hydroxymethylcellulose, methyl or propylparabens.
- •4. Strong analgesia, such as opioid containing compounds is not permissible; must be stopped at the Screening Visit.
- •5. History of regular NSAID use.
- •6. Oral 5-aminosalicylate (5-ASA) compounds; exclude patients 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 patients 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 patients 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 Visit.
- •12. Previous use of alicaforsen is permitted: treatment course must have completed at least 12 weeks prior to the Screening Visit. (Alicaforsen pre-treated patients may not contribute to the primary efficacy analysis.)
- •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. History of faecal transplantation
- •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
- •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 received nasogastric/nasoenteric Bottle feeding, an elemental diet, or total parenteral nutrition within the 2 weeks prior to Day 1
- •26. Subjects with a history of clinically significant and/or persistent illness; which in the investigators opinion, would exclude entry into the trial
- •27. Subjects with any laboratory tests considered clinically significant at screening
- •28. Subjects who may be unavailable for the duration of the trial, likely to be noncompliant with the protocol, or who are felt to be unsuitable by the Investigator for any other reason including, for example, inability to retain an enema formulation
- •29. Pelvic sepsis should be excluded as a differential diagnosis, for example by MRI within 12 months of randomization.
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