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Clostridium Difficile Associated DiarrheaPhase 2NCT01559545

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

A Phase 2 study testing Metronidazole, Metronidazole-DRF1 and Metronidazole-DRF2 in people with Clostridium Difficile Associated Diarrhea, run by Dr. Reddy's Laboratories Limited at 12 sites in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Metronidazole, Metronidazole-DRF1 and Metronidazole-DRF2
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
12 sitesIndia
Study dates
Mar 2012to Mar 2013
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male and female patients 18 years of age or older
  • Mild to moderate C.difficile associated diarrhea (CDAD) with a positive stool C.difficile toxin (by ELISA).
  • Either a first episode of CDAD or a first recurrence (patients with more than 1 recurrence are not eligible)
  • Greater than 3 watery or unformed bowel movements in the prior 24 hours
  • Females of child bearing potential having a negative pregnancy test and taking adequate birth control measures.
  • 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).
  • Able to comprehend and give informed consent for the study and able to adhere to study schedules and protocol requirements.

Who cannot join

  • Known prior history of hypersensitivity to metronidazole or other nitroimidazole derivatives
  • Life expectancy ≤ 60 days
  • Sepsis, severe sepsis, or septic shock
  • Signs or symptoms of peritonitis, megacolon or ileus
  • History of ulcerative colitis or Crohn's disease
  • 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
Show all 13Show fewer
  • Recent history of significant drug or alcohol abuse within 1 year
  • 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
  • Patients with history of blood dyscrasias, porphyria and active non-infectious disease of the central nervous system
  • Patients with history of rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
  • Pregnant or lactating female patients
  • 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
  • Unable to participate in the study for any reason in the opinion of the Principal Investigator

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

India12 sites

  • Dr. B.R. Ambedkar Medical College

    Bangalore, Karnataka

  • St. John's Medical College and Hospital

    Bangalore, Karnataka

  • S.P. Medical College and Hospital

    Bikaner, Rajasthan

  • Apex Medicical College

    Jaipur, Rajasthan

  • Heritage Hospital

    Lanka, Varanasi

  • Meenakshi Mission Hospital and Research Center

    Madurai, Tamil Nadu

  • B.Y.L. Nair Hospital

    Mumbai, Maharashtra

  • Chopda Research and Medical Center Pvt

    Nashik, Maharashtra

  • Deenanath Mangeshkar Hospital

    Pune, Maharashtra

  • Ruby Hall Clinic

    Pune, Maharashtra

  • SKS Hospital India Pvt. Ltd.

    Salem, Tamil Nadu

  • PRS Hospitals

    Trivandrum, Kerala

Other trials in India

About this study

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)

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.

Being tested
Metronidazole, Metronidazole-DRF1, Metronidazole-DRF2
Keywords
Clostridium difficile associated diarrhea, Metronidazole, CDAD

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MetronidazoleDrug

    Also called Flagyl®

    Immediate release metronidazole 500 mg orally three times a day for 14 days

  • Metronidazole-DRF1Drug

    Also called Metronidazole

    Modified release metronidazole (DRF1) 500 mg orally three times a day for 14 days.

  • Metronidazole-DRF2Drug

    Also called Metronidazole

    Modified release metronidazole (DRF2) 500 mg orally three times a day for 14 days.

Study groups in NCT01559545
Study groupRoleWhat they receive
MetronidazoleActive comparatorImmediate release metronidazole
Receives: Drug: Metronidazole
Metronidazole-DRF1ExperimentalModified release metronidazole (DRF1)
Receives: Drug: Metronidazole-DRF1
Metronidazole-DRF2ExperimentalModified release metronidazole (DRF2)
Receives: Drug: Metronidazole-DRF2

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tolerability

    Tolerability as assessed by physical examination, ECG, clinical laboratory tests and adverse events

    Measured: 44 Days

  2. 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.

    Measured: 14 Days

Secondary outcomes (3)

  1. 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).

    Measured: 44 Days

  2. Recurrence Rate

    Recurrence defined as re-establishment of diarrhea after clinical cure.

    Measured: 44 Days

  3. 30-Day Cure Rate

    Clinical cure with no recurrence and no retreatment for 30 days after 14 days of metronidazole treatment (Day 44).

    Measured: 44 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Mar 2012 (estimated)
  2. Study startMar 2012
  3. Primary completionFeb 2013
  4. Study completionMar 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01559545
Sponsor's protocol ID
DFA-03-CD-002
Status last verified
Jun 2013
First submitted
19 Mar 2012
Last updated
7 Jun 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Metronidazole, Metronidazole-DRF1 and Metronidazole-DRF2 in people with Clostridium Difficile Associated Diarrhea, run by Dr. Reddy's Laboratories Limited at 12 sites in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tolerability (time frame: 44 Days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01559545.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2013.

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