A Study of GT160-246 Versus Vancomycin in Patients With Clostridium Difficile-Associated Diarrhea

March 4, 2015 updated by: Genzyme, a Sanofi Company

A Randomized, Double-Blind Study of GT160-246 Versus Vancomycin in Patients With C. Difficile-Associated Diarrhea

Approximately 300 patients will be entered into this study taking place throughout the United States, Canada and the United Kingdom. This study aims to determine if an investigational drug is safe and effective for treating the symptoms of C. difficile-associated diarrhea and lowering the risk of repeat episodes of diarrhea. The investigational drug will be evaluated in comparison to current standard antibiotic treatment, so all patients will receive active medication.

All study-related care is provided including doctor visits, physical exams, laboratory tests and study medication. Total length of participation is approximately 10 weeks.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

300

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada, G1R 2J6 and G1L 3L5
    • Alberta
      • Calgary, Alberta, Canada, T2N 1T9
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
      • Vancouver, British Columbia, Canada, V5Z 3J5
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1R9
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1C 6Z8
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
      • Windsor, Ontario, Canada, N9A 1C9
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 5H6
      • Montreal, Quebec, Canada, H1T 2M4
      • Montreal, Quebec, Canada, H3T 1E2
      • Montreal, Quebec, Canada, H2L 4M1
      • Trois-Rivieres, Quebec, Canada, G9A 1Y1
  • Puerto Rico
      • Hato Rey, Puerto Rico, 00918
  • United Kingdom
      • Birmingham, United Kingdom, B95SS
      • Birmingham, United Kingdom, B18 7QH
      • Cambridge, United Kingdom, CB2 2QQ
      • Edinburgh, United Kingdom, EH4 2XU
      • Glasgow, United Kingdom, G21 3UR
      • Hull, United Kingdom, HU3 2JZ
      • Leeds, United Kingdom, LS1 3EX
      • Leicester, United Kingdom, LE1 5WW
      • London, United Kingdom, SW17 0QT
      • London, United Kingdom, N19 5LW
      • London, United Kingdom, W1N 8AA
      • Newport, United Kingdom, NP20 2UB
      • Nottingham, United Kingdom, NG7 2UH
      • Shrewsbury, United Kingdom, SY3 8XQ
      • Taunton, United Kingdom, TA1 5DA
      • Wolverhampton, United Kingdom, WV10 0QP
    • Cardiff
      • Heath Park, Cardiff, United Kingdom, CF4 4XW
      • Penlan Rd, Cardiff, United Kingdom, CF64 2XX
    • Keighley
      • Steeton, Keighley, United Kingdom, BD20 6TD
    • Lancashire
      • Bury, Lancashire, United Kingdom, BL9 7TD
    • London
      • Chelsea, London, United Kingdom, SW10 9NH
      • South Kensington, London, United Kingdom, SW7 2AZ
    • Newcastle-upon-Tyne
      • High Heaton, Newcastle-upon-Tyne, United Kingdom, NE7 7DN
    • Northampton
      • Cliftonville, Northampton, United Kingdom, NN1 5BD
    • Preston
      • Fulwood, Preston, United Kingdom, PR7 1PP
    • Stirling
      • Livilands, Stirling, United Kingdom, FK8 2AU
    • Swansea
      • Morriston, Swansea, United Kingdom, SA6 6NL
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36617
    • Arizona
      • Phoenix, Arizona, United States, 85006
      • Tucson, Arizona, United States, 85724
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
    • California
      • Sacramento, California, United States, 95816
    • Delaware
      • Newark, Delaware, United States, 19718
    • Florida
      • Bay Pines, Florida, United States, 33744
      • Brandon, Florida, United States, 33511
      • Hollywood, Florida, United States, 33021
      • Naples, Florida, United States, 34102
      • Orlando, Florida, United States, 32806
    • Georgia
      • Austell, Georgia, United States, 30106
      • Columbus, Georgia, United States, 31902
    • Illinois
      • Chicago, Illinois, United States, 60611
      • Maywood, Illinois, United States, 60153
      • North Chicago, Illinois, United States, 60064
    • Indiana
      • Columbus, Indiana, United States, 47203
    • Iowa
      • Des Moines, Iowa, United States, 50309
      • Des Moines, Iowa, United States, 50314
    • Kansas
      • Wichita, Kansas, United States, 67214
    • Kentucky
      • Lexington, Kentucky, United States, 40536-0084
      • Louisville, Kentucky, United States, 40202
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
    • Maryland
      • Baltimore, Maryland, United States, 21215
      • Chevy Chase, Maryland, United States, 20815
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
      • Braintree, Massachusetts, United States, 02185
      • West Roxbury, Massachusetts, United States, 02132
    • Missouri
      • Springfield, Missouri, United States, 65807
      • St. Louis, Missouri, United States, 63110
    • New Jersey
      • Stratford, New Jersey, United States, 08084
    • New York
      • Buffalo, New York, United States, 14215
      • Jamaica, New York, United States, 11432
      • Manhasset, New York, United States, 11030
      • New York, New York, United States, 10032
      • New York, New York, United States, 10010
      • Syracuse, New York, United States, 13210
    • North Carolina
      • Asheville, North Carolina, United States, 28801
      • Charlotte, North Carolina, United States, 28203
    • North Dakota
      • Fargo, North Dakota, United States, 58122
    • Ohio
      • Columbus, Ohio, United States, 43215
      • Toledo, Ohio, United States, 43608
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18105
      • Hershey, Pennsylvania, United States, 17033
      • Philadelphia, Pennsylvania, United States, 19140
      • Philadelphia, Pennsylvania, United States, 19102
      • Philadelphia, Pennsylvania, United States, 19129
      • Pittsburgh, Pennsylvania, United States, 15261
      • Upland, Pennsylvania, United States, 19013
    • South Carolina
      • Charleston, South Carolina, United States, 29425
    • Tennessee
      • Clarksville, Tennessee, United States, 37043
      • Memphis, Tennessee, United States, 38104
    • Texas
      • Temple, Texas, United States, 76508
    • Virginia
      • Falls Church, Virginia, United States, 22042
      • Richmond, Virginia, United States, 23249
      • Richmond, Virginia, United States, 23294
    • Washington
      • Seattle, Washington, United States, 98104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Be at least 18 years old.
  • Have active mild to moderate C. difficile- Associated Diarrhea (CDAD).
  • Be able to tolerate oral medication.
  • Not be pregnant or breast-feeding.
  • Sign and date an informed consent form.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genzyme, a Sanofi Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2002

Study Completion (Actual)

July 1, 2003

Study Registration Dates

First Submitted

April 24, 2002

First Submitted That Met QC Criteria

April 24, 2002

First Posted (Estimate)

April 25, 2002

Study Record Updates

Last Update Posted (Estimate)

March 5, 2015

Last Update Submitted That Met QC Criteria

March 4, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GTC-80-203
  • GT1105

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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