NCT01559545 - A Safety, Tolerability and Pharmacokinetic Study of Two Formulations of Metronidazole Versus Immediate Release Metronidazole in Patient With C. Difficile Colitis | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

March 31, 2012

Primary Completion Date

February 28, 2013

Study Completion Date

March 31, 2013

Conditions

Clostridium Difficile Associated Diarrhea

Interventions

DRUG

Metronidazole

Immediate release metronidazole 500 mg orally three times a day for 14 days

DRUG

Metronidazole-DRF1

Modified release metronidazole (DRF1) 500 mg orally three times a day for 14 days.

DRUG

Metronidazole-DRF2

Modified release metronidazole (DRF2) 500 mg orally three times a day for 14 days.

Trial Locations (12)

Dr. B.R. Ambedkar Medical College, Bangalore

St. John's Medical College and Hospital, Bangalore

PRS Hospitals, Trivandrum

B.Y.L. Nair Hospital, Mumbai

Chopda Research and Medical Center Pvt, Nashik

Deenanath Mangeshkar Hospital, Pune

Ruby Hall Clinic, Pune

S.P. Medical College and Hospital, Bikaner

Apex Medicical College, Jaipur

Meenakshi Mission Hospital and Research Center, Madurai

SKS Hospital India Pvt. Ltd., Salem

Heritage Hospital, Lanka