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)
| Verified date | June 2013 |
| Source | Dr. Reddy's Laboratories Limited |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | India: Drugs Controller General of India |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 60 |
| Est. completion date | March 2013 |
| Est. primary completion date | February 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| India | Dr. B.R. Ambedkar Medical College | Bangalore | Karnataka |
| India | St. John's Medical College and Hospital | Bangalore | Karnataka |
| India | S.P. Medical College and Hospital | Bikaner | Rajasthan |
| India | Apex Medicical College | Jaipur | Rajasthan |
| India | Heritage Hospital | Lanka | Varanasi |
| India | Meenakshi Mission Hospital and Research Center | Madurai | Tamil Nadu |
| India | B.Y.L. Nair Hospital | Mumbai | Maharashtra |
| India | Chopda Research and Medical Center Pvt | Nashik | Maharashtra |
| India | Deenanath Mangeshkar Hospital | Pune | Maharastra |
| India | Ruby Hall Clinic | Pune | Maharashtra |
| India | SKS Hospital India Pvt. Ltd. | Salem | Tamil Nadu |
| India | PRS Hospitals | Trivandrum | Kerala |
| Lead Sponsor | Collaborator |
|---|---|
| Dr. Reddy's Laboratories Limited | Reliance Clinical Research Services (Navi Mumbai, India) |
India,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Tolerability | Tolerability as assessed by physical examination, ECG, clinical laboratory tests and adverse events | 44 Days | Yes |
| Primary | Pharmacokinetics | Systemic pharmacokinetics of metronidazole on Days 1 and 14. Intraluminal colonic concentration of metronidazole as reflected in excreted stool on Days 1 and 14. | 14 Days | Yes |
| Secondary | Clinical Cure | Response rate to treatment 2 days after completion of 14 days of metronidazole treatment with no recurrence 30 days after 14 days of metronidazole treatment (Day 44). | 44 Days | No |
| Secondary | Recurrence Rate | Recurrence defined as re-establishment of diarrhea after clinical cure. | 44 Days | No |
| Secondary | 30-Day Cure Rate | Clinical cure with no recurrence and no retreatment for 30 days after 14 days of metronidazole treatment (Day 44). | 44 Days | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Withdrawn |
NCT01596153 -
Probiotics in Hospitalized Patients Study
|
N/A |