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Label indication VANDAZOLE ® is indicated in the treatment of bacterial vaginosis (formerly referred to as Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, Corynebacterium vaginitis, or anaerobic vaginosis) in post-menarchal females. VANDAZOLE is a nitroimidazole antimicrobial indicated for the treatment of bacterial vaginosis in post-menarchal females. ( 1 ) FDA label
Also known as Flagyl®, Metronidazole-DRF1, Metronidazole-DRF2
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. ...
Metronidazole is being studied for the treatment of Clostridium difficile associated diarrhea, an infectious disease of the gut. Dr. Reddy's Laboratories Ltd is developing this small molecule formulation for that indication. The program is in Phase 2 clinical development, so it is investigational rather than an approved product for this use.
Dr. Reddy's Laboratories Ltd, which trades under the ticker RDY, is the developer of this Metronidazole program for Clostridium difficile associated diarrhea. The company sponsored the Phase 2 study of two Metronidazole formulations compared with immediate release Metronidazole in patients with C. difficile colitis.
Metronidazole is in Phase 2 development for Clostridium difficile associated diarrhea. One Phase 2 trial has been completed, and no trials in this program are currently active. Because the program is still in clinical development, this Metronidazole formulation is investigational and has not been established as an approved treatment for this indication.
The program includes one completed Phase 2 trial, NCT01559545, titled a safety, tolerability and pharmacokinetic study of two formulations of Metronidazole versus immediate release Metronidazole in patients with C. difficile colitis. It enrolled 60 patients aged 18 years and older in India, was randomized and active controlled, and did not use a double blind design.
NCT01559545 was an active controlled, randomized Phase 2 study that compared two Metronidazole formulations against immediate release Metronidazole in patients with C. difficile colitis. It enrolled 60 patients, was not double blinded, and did not select patients by biomarker. The study is complete and took place in India.