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

NCT01559545 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2013-06-07

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Reliance Clinical Research Services (Navi Mumbai, India)

    collaborator UNKNOWN

  • Dr. Reddy's Laboratories Limited

    lead INDUSTRY

Principal Investigators

  • Dilip Pawar, MD · Dr. Reddy's Laboratories Limited

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2013-02-28
Completion
2013-03-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01559545 on ClinicalTrials.gov