Clostridium Difficile Associated Diarrhea Clinical Trial
Official title:
A Randomized, Open Label, Active Control, Safety, Tolerability and Pharmacokinetics Study of Two Dr. Reddy's Formulations of Metronidazole Versus Immediate Release Metronidazole (Flagyl) in Patients With Mild to Moderate C. Difficile Associated Diarrhea (CDAD)
Clostridium difficile bacteria can be a cause of significant diarrheal disease, particularly
in people who have taken potent antibiotics. When C. difficile multiplies within the colon,
it produces two toxins that cause inflammation and resultant abdominal pain, fever and
diarrhea. Current treatment of mild to moderate disease is with immediate release
metronidazole, an antibiotic that kills C. difficile. Dr. Reddy's Laboratories has developed
a delayed release form of metronidazole to release just before the colon to increase the
concentration of antibiotic in the colon to improve the effectiveness of metronidazole
treatment and potentially to allow less whole body exposure to the antibiotic.
This study will measure the amount of metronidazole in the blood and stool of patients with
C. difficile associated diarrhea (CDAD) to confirm that the new formulations are releasing
the antibiotic as designed, immediately before the colon.
n/a
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
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Withdrawn |
NCT01596153 -
Probiotics in Hospitalized Patients Study
|
N/A |