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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01559545
Other study ID # DFA-03-CD-002
Secondary ID
Status Completed
Phase Phase 2
First received March 19, 2012
Last updated June 6, 2013
Start date March 2012
Est. completion date March 2013

Study information

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

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms

  • Clostridium Difficile Associated Diarrhea
  • Diarrhea

Intervention

Drug:
Metronidazole
Immediate release metronidazole 500 mg orally three times a day for 14 days
Metronidazole-DRF1
Modified release metronidazole (DRF1) 500 mg orally three times a day for 14 days.
Metronidazole-DRF2
Modified release metronidazole (DRF2) 500 mg orally three times a day for 14 days.

Locations

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

Sponsors (2)

Lead Sponsor Collaborator
Dr. Reddy's Laboratories Limited Reliance Clinical Research Services (Navi Mumbai, India)

Country where clinical trial is conducted

India, 

Outcome

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
See also
  Status Clinical Trial Phase
Withdrawn NCT01596153 - Probiotics in Hospitalized Patients Study N/A