Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Metronidazole · 1 trial · 1 indication
Tolerability as assessed by physical examination, ECG, clinical laboratory tests and adverse events
Systemic pharmacokinetics of metronidazole on Days 1 and 14. Intraluminal colonic concentration of metronidazole as reflected in excreted stool on Days 1 and 14.
| Arm | Type | Description |
|---|---|---|
| Metronidazole | ACTIVE_COMPARATOR | Immediate release metronidazole |
| Metronidazole-DRF1 | EXPERIMENTAL | Modified release metronidazole (DRF1) |
| Metronidazole-DRF2 | EXPERIMENTAL | Modified release metronidazole (DRF2) |
| Name | Type | Description |
|---|---|---|
| Metronidazole | DRUG | Immediate release metronidazole 500 mg orally three times a day for 14 days |
| Metronidazole-DRF1 | DRUG | Modified release metronidazole (DRF1) 500 mg orally three times a day for 14 days. |
| Metronidazole-DRF2 | DRUG | Modified release metronidazole (DRF2) 500 mg orally three times a day for 14 days. |
Inclusion Criteria: 1. Male and female patients 18 years of age or older 2. Mild to moderate C.difficile associated diarrhea (CDAD) with a positive stool C.difficile toxin (by ELISA). 3. Either a first episode of CDAD or a first recurrence (patients with more than 1 recurrence are not eligible) 4. ...