Pouchitis MedDRA version: 12.0 Level: LLT Classification code 10036463 Term: Pouchitis
Conditions
Interventions
Product Name: Metronidazole capsule 50 mg
Product Code: FP-110
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Metronidazole
CAS Number: 44-348-1
Current Sponsor code: Fp-110
Concentration uni
Sponsors
FORMAC Pharmaceuticals NV
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the pharmacokinetics of two dosages of a modified release formulation of metronidazole in subjects with active acute or chronic pouchitis and compare it to the current standard immediate release formulation of metronidazole (Flagyl 500 mg). ;Secondary Objective: Exploratory, safety and efficacy of the treatment will also be evaluated to see whether change in systemic exposure reduces side effects and whether the modified release formulation shows clinical benefit to the subjects.;Primary end point(s): Pharmacokinetics of the formulations: The AUC of the modified release formulations, calculated on equivalent dose, must be significantly lower compared to the immediate release formulation of metronidazole | — |
Countries
Belgium
Outcome results
None listed