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

Conditions: Pouchitis
MedDRA version: 12.0Level: LLTClassification code 10036463Term: Pouchitis

Registration Number: EUCTR2009-015136-14-BE

Lead Sponsor: FORMAC Pharmaceuticals NV

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

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.