A Study of GT267-004 Versus Vancomycin and GT267-004 Versus Metronidazole in Patients With C. Difficile-Associated Diarrhea

March 17, 2014 updated by: Genzyme, a Sanofi Company

A Randomized, Double-Blind Study of GT267-004 Versus Vancomycin, and GT267-004 Versus Metronidazole in Patients With C. Difficile-Associated Diarrhea

Approximately 520 patients will be entered into this study taking place throughout Australia and Europe. This study aims to determine if an investigational drug is safe and effective for treating symptoms of C. difficile-associated diarrhea (CDAD) and lowering the risk of repeat episodes of CDAD. 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. The total length of participation is approximately 6 weeks.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

520

Phase

  • Phase 3

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

  • Australia
      • Adelaide, Australia, 5000
      • Bedford Park, Australia, 5042
      • Cairns, Australia, 4870
      • Concord, Australia, 2139
      • Darlinghurst, Australia, 2010
      • Five Dock, Australia, 2046
      • Footscray, Australia, 3011
      • Herston, Australia, 4032
      • Hobart, Australia, 7000
      • Kogarah, Australia, 2217
      • Nambour, Australia, 4560
      • Nedlands, Australia, 6009
      • Parkville, Australia, 3050
      • Perth, Australia, 6000
      • Randwick, Australia, 2031
      • South Brisbane, Australia, 4101
      • Southport, Australia, 4215
      • Woolloongabba, Australia, 4102
  • Austria
      • Innsbruck, Austria, 6020
      • Linz, Austria, 4020
      • Linz, Austria, 4010
      • Oberndorf, Austria, 5110
      • Salzburg, Austria, 5020
  • Belgium
      • Aalst, Belgium, 9300
      • Braine L'Alleud, Belgium, 1420
      • Brussels, Belgium, 1000
      • Brussels, Belgium, 1200
      • Brussels, Belgium, 1070
      • Gent, Belgium, B-9000
      • Hasselt, Belgium, 3500
      • Leuven, Belgium, 3000
      • Yvoir, Belgium, B-5330
  • Czech Republic
      • Brno, Czech Republic, 62500
      • Hradec Kralove, Czech Republic, 50005
      • Melnik, Czech Republic, 276 01
      • Ostrava, Czech Republic, 708 52
      • Praha, Czech Republic, 180 81
      • Praha, Czech Republic, 128 20
  • Denmark
      • Copenhagen, Denmark, DK-2400
      • Copenhagen, Denmark, DK-2200
      • Herlev, Denmark, DK-2730
      • Hvidovre, Denmark, DK-2650
  • France
      • Amiens, France, 80054
      • Annecy, France, 74000
      • Clichy, France, 92110
      • Creteil, France, 94010
      • Dijon, France, 21000
      • Garches, France, 92380
      • Nice, France, 06200
      • Paris, France, 75018
      • Paris, France, 75010
      • Paris, France, 75679
      • Paris, France, 75020
      • Saint Etienne, France, 42055
      • Tourcoing, France, 59200
      • Vandoeuvre-les-Nancy, France, 54511
  • Germany
      • Augsburg, Germany, 86156
      • Berlin, Germany, 12200
      • Düsseldorf, Germany, 40472
      • Frankfurt, Germany, 60590
      • Frankfurt, Germany, 60487
      • Greifswald, Germany, 17491
      • Hannover, Germany, 30625
      • Hofheim, Germany, 65719
      • Köln, Germany, 50937
      • Leipzig, Germany, 4157
      • Lübeck, Germany, 23538
      • Regensburg, Germany, 93053
      • Wilhelmshaven, Germany, 26384
  • Ireland
      • Castlebar, Ireland
      • Cork, Ireland
      • Dublin, Ireland
  • Norway
      • Bergen, Norway, N-5021
      • Bergen, Norway, N-5009
      • Bodo, Norway, N-8005
      • Oslo, Norway, N-0407
      • Stavanger, Norway, N-4068
      • Tonsberg, Norway, 3103
      • Tromso, Norway, 9038
      • Trondheim, Norway, 7006
  • Portugal
      • Carnaxide, Portugal, 2790-134
      • Coimbra, Portugal, 3000-075
      • Matosinhos, Portugal, 4450
      • Porto, Portugal, 4099-001
  • Spain
      • Alcala de Henares, Spain, 28805
      • Badalona, Spain, 8911
      • Badalona, Spain, 8915
      • Barcelona, Spain, 08036
      • Barcelona, Spain, 08035
      • Barcelona, Spain, 8025
      • Cordoba, Spain, 14004
      • El Palmar-Murcia, Spain, 30120
      • Guadalajara, Spain, 19002
      • Leganes, Spain, 28911
      • Lleida, Spain, 25198
      • Madrid, Spain, 28040
      • Madrid, Spain, 28041
      • Madrid, Spain, 28007
      • Madrid, Spain, 28035
      • San Sebastian, Spain, 20014
      • Santander, Spain, 39008
      • Sevilla, Spain, 41014
      • Sevilla, Spain, 41013
      • Sevilla, Spain, 41071
      • Terrassa, Spain, 8221
  • Sweden
      • Goteborg, Sweden, SE-416 85
      • Joenkoeping, Sweden, SE-551 85
      • Kalmar, Sweden, SE-391 85
      • Karlskrona, Sweden, SE-371 85
      • Kristianstad, Sweden, SE-291 85
      • Lund, Sweden, SE-221 85
      • Malmö, Sweden, SE-205 85
      • Oerebro, Sweden, SE-701 85
      • Skoevde, Sweden, SE-541 85
  • Switzerland
      • Baden, Switzerland, 5404
      • Basel, Switzerland, 4031
      • Bellinzona, Switzerland, 6500
      • Geneva, Switzerland, 1211
      • Lugano, Switzerland, 6903
  • United Kingdom
      • Abergavenny, United Kingdom, NP7 7EG
      • Birmingham, United Kingdom, B15 2TT
      • Bristol, United Kingdom, BS16 1LE
      • Bury, United Kingdom, BL9 7TD
      • Cardiff, United Kingdom, CF14 4XW
      • Cardiff, United Kingdom, CF64 2XX
      • Edinburgh, United Kingdom, EH4 2XU
      • Gwent, United Kingdom, NP20 2UB
      • Ipswich, United Kingdom, IP4 5PD
      • Keighley, United Kingdom, BD20 6TD
      • Leeds, United Kingdom, LS1 3EX
      • Liverpool, United Kingdom, L7 8XP
      • London, United Kingdom, SE13 6LH
      • London, United Kingdom, W1M 3TT
      • Salford, United Kingdom, M6 8HD
      • Sheffield, United Kingdom, S10 2JF
      • Stockport, United Kingdom, SK2 7JE
      • Sunderland, United Kingdom, SR4 7TP
      • Winchester, United Kingdom, SO22 5DG

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:

  • 18 years of age and above
  • The presence of CDAD at the time of enrollment with no other likely etiology for the diarrhea
  • Less than or equal to 48 hours of treatment with metronidazole, vancomycin or other antibacterial therapy specific for CDAD
  • Baseline serum potassium > 3.0 mmol (meq)/L
  • Patient considered sufficiently stable clinically to likely complete 6 week study period.

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
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Resolution of diarrhea

Secondary Outcome Measures

Outcome Measure
Time to resolution of diarrhea
Recurrence rate
Number of stools
Average stool consistency
Treatment success

Collaborators and Investigators

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

Sponsor

Genzyme, a Sanofi Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

April 1, 2005

Study Completion (ACTUAL)

August 1, 2007

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (ESTIMATE)

September 20, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

March 19, 2014

Last Update Submitted That Met QC Criteria

March 17, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GD3-170-302

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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