A Safety, Tolerability and Pharmacokinetic Study of Two Formulations of Metronidazole Versus Immediate Release Metronidazole in Patient With C. Difficile Colitis
Information source: Dr. Reddy's Laboratories Limited
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Clostridium Difficile Associated Diarrhea
Intervention: Metronidazole (Drug); Metronidazole-DRF1 (Drug); Metronidazole-DRF2 (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Dr. Reddy's Laboratories Limited Official(s) and/or principal investigator(s): Dilip Pawar, MD, Study Director, Affiliation: Dr Reddy's Laboratories Ltd.
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.
Clinical Details
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)
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: TolerabilityPharmacokinetics
Secondary outcome: Clinical CureRecurrence Rate 30-Day Cure Rate
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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. Greater than 3 watery or unformed bowel movements in the prior 24 hours
5. Females of child bearing potential having a negative pregnancy test and taking
adequate birth control measures.
6. Patients should not consume alcohol at least 12 hours prior to dosing (i. e. in-house
monitoring) and until 48 hours after the last dose of drug administration (until Day
14).
7. Able to comprehend and give informed consent for the study and able to adhere to
study schedules and protocol requirements.
Exclusion Criteria:
1. Known prior history of hypersensitivity to metronidazole or other nitroimidazole
derivatives
2. Life expectancy ≤ 60 days
3. Sepsis, severe sepsis, or septic shock
4. Signs or symptoms of peritonitis, megacolon or ileus
5. History of ulcerative colitis or Crohn's disease
6. Oral or parenteral antibiotic therapy with metronidazole or vancomycin or other drugs
effective in treating DCAD (e. g., bacitracin, fusidic acid) within the 1 week prior
to enrollment
7. Recent history of significant drug or alcohol abuse within 1 year
8. Any findings on physical examination, medical history, 12-lead ECG or clinical
laboratory tests which, in the judgment of the Principal Investigator, would exclude
patients from participating in the study
9. Patients with history of blood dyscrasias, porphyria and active non-infectious
disease of the central nervous system
10. Patients with history of rare hereditary problems of galactose intolerance, the Lapp
lactase deficiency or glucose-galactose malabsorption
11. Pregnant or lactating female patients
12. Participation within 30 days before the start of this study in any experimental drug
or device study, or currently participating in a study in which the administration of
investigational drug or device within 60 days is anticipated
13. Unable to participate in the study for any reason in the opinion of the Principal
Investigator
Locations and Contacts
Dr. B.R. Ambedkar Medical College, Bangalore, Karnataka, India
St. John's Medical College and Hospital, Bangalore, Karnataka, India
PRS Hospitals, Trivandrum, Kerala, India
B.Y.L. Nair Hospital, Mumbai, Maharashtra, India
Chopda Research and Medical Center Pvt, Nashik, Maharashtra, India
Ruby Hall Clinic, Pune, Maharashtra, India
Deenanath Mangeshkar Hospital, Pune, Maharastra, India
S.P. Medical College and Hospital, Bikaner, Rajasthan, India
Apex Medicical College, Jaipur, Rajasthan, India
Meenakshi Mission Hospital and Research Center, Madurai, Tamil Nadu, India
SKS Hospital India Pvt. Ltd., Salem, Tamil Nadu, India
Heritage Hospital, Lanka, Varanasi, India
Additional Information
Starting date: March 2012
Last updated: June 6, 2013
|