Health Condition 1: null- C. difficile associated diarrhea (CDAD)
Conditions
Interventions
Intervention1: 2nd Intervention arm : Metronidazole DRF2: Each tablet contains Metronidazole USP 500mg
Therapeutic class: Antiprotozoal and Antibacterial agent.
Intervention agent.
Dose: Single dose
Sponsors
Dr Reddys Laboratories Ltd
Dr Reddys Laboratories Ltd
Reliance Clinical Research Services a division of Reliance Life Sciences Pvt Ltd
Eligibility
Inclusion criteria
Inclusion 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 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
Exclusion criteria: 1. Known prior history of hypersensitivity to metronidazole or other nitroimidazole derivatives 2. Life expectancy 3. Sepsis, severe sepsis, or septic shock 4. Signs or symptoms of peritonitis, megacolon or ileus 5. History of ulcerative colitis or Crohnâ??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 noninfectious disease of 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is to assess safety and tolerability which will be assessed by Physical Examination for GI signs and symptoms and vital signs will be doneTimepoint: Physical examination & vital signs â??Day 2, Day 7, Day 14, Day 15, Day 28 and Day 44 ECG- Day 15 Lab evaluation-Day 2, Day 15, Day 28 and Day 44 AE- each visit | — |
Secondary
| Measure | Time frame |
|---|---|
| 30-Day Clinical Cure rate to treatment with the three formulations. 30-Day Cure Rate as defined as patients achieving a Clinical Cure with no Recurrence and no retreatment with CDAD anti-infective therapy for 30 days (Study Day 44) after initiation of treatment for the primary episode of CDAD.Timepoint: Study day 44;Recurrence Rate to treatment with the three formulations. Recurrence Rate as defined by re-establishment of diarrhea after Clinical Cure to an extent that is greater than that noted on the last day of study medication and that, in the Investigatorâ??s opinion, requires retreatment with CDAD anti-infective therapyTimepoint: Event based;Response rate to treatment with the three formulations as measured by Clinical Cure. The Response Rate to each formulation as measured by Clinical Cure defined as patients whoTimepoint: Event based | — |
Countries
India
Contacts
Public ContactDr Dilip Pawar
Dr Reddys Laboratories Ltd Proprietary Products R&D
Outcome results
None listed