Modified release metronidazole for the treatment of pouchitis after colectomy with ileo-anal pouch anastomosis for ulcerative colitis: a pharmacokinetic study

FORMAC Pharmaceuticals NV0 个研究点开始时间: 2009年10月12日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•1. Males or females aged > 18 years.
•2. Subjects with IPAA (ileo-anal pouch anastomosis) who have a functioning pouch without
•ileostomy for at least 6 months.
•3. Subjects with a PDAI score of >7 (Appendix 3).
•4. Subjects with acute active pouchitis or chronic active pouchitis diagnosed by endoscopy with biopsy
•5. Subjects willing and able to give written informed consent to participate in the study.
•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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•1. Evidence of ongoing or recent (within 14 days) gastrointestinal infection or positive stool culture for enteric pathogens or C. difficile toxin positivity
•2. Subjects with a pouch related fistula or stenosis of pouch outlet
•3. Female subjects who are pregnant or lactating, or are of childbearing potential and not practicing a medically acceptable method for birth control
•4. Subjects with documented hypersensitivity to nitro-imidazol antibiotics
•5. Subjects who have taken antibiotics within 3 days of the study
•6. Subjects who participated to the trial in the previous 14 days
•7. Subjects who have received metronidazole in the previous 14 days.

发起方