NCT01559545

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

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Dr. Reddy's Laboratories Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Clostridium Difficile Associated Diarrhea

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2012-03-01
• Primary completion: 2013-02-01
• Completion: 2013-03-01
• First posted: 2012-03-21
• Last updated: 2013-06-07

Locations

12 sites across 1 country: India