Approximately 520 patients will be entered into this study taking place throughout the US and Canada. 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...
Date First Received: March 25, 2005
Last Updated: April 29, 2007
Verified by: Genzyme, April 2007
Clinical Trial Phase: Phase 3 | Start Date: March 2005
Overall Status: Completed
Estimated Enrollment: 520
Brief Summary
Official Title: “A Randomized, Double-Blind Study of GT267-004 Versus Vancomycin, and GT267-004 Versus Metronidazole, in Patients With C.Difficile - Associated Diarrhea”
Condition Keyword(s):
Intervention(s):
Approximately 520 patients will be entered into this study taking place throughout the US and Canada. 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. Total length of participation is approximately 6 weeks.
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Outcome Measures for this Clinical Trial
Primary:
- Resolution of diarrhea
Secondary:
- Time to resolution of diarrhea
- Recurrence rate
- Number of stools
- Average stool consistency
- Treatment success
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- 18 years of age
- 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 a 6 week study period
Clinical Trials Locations, Contact Details, and Sponsors
Lead Sponsor: Genzyme
Phoenix Arizona 85006 United States
Phoenix Arizona 85012 United States
Rogers Arkansas 72756 United States
Burbank California 91505 United States
Newport Beach California 92663 United States
Los Angeles California 90073 United States
Los Angeles California 90089 United States
Modesto California 95350 United States
Sacramento California 95817 United States
San Diego California 92103 United States
Los Angeles California 90095 United States
Denver Colorado 80218-1191 United States
Denver Colorado 80210 United States
Denver Colorado 80262 United States
Denver Colorado 80204 United States
Newark Delaware 19718 United States
Bay Pines Florida 33744 United States
Jacksonville Florida 32207 United States
Zephyrhills Florida 33542 United States
Tampa Florida 33607 United States
Brooksville Florida 34613 United States
Brandon Florida 33511 United States
Atlanta Georgia 30309 United States
Ft. Gordon Georgia 30905 United States
Savannah Georgia 31405 United States
Honolulu Hawaii 96813 United States
Honolulu Hawaii 96813 United States
Maywood Illinois 60153 United States
Chicago Illinois 60634 United States
North Chicago Illinois 60064 United States
Hines Illinois 60141 United States
Decatur Illinois 62526 United States
Lafayette Indiana 47904 United States
Muncie Indiana 47303 United States
Anderson Indiana 46011 United States
Indianapolis Indiana 46202 United States
Des Moines Iowa 50302 United States
Clive Iowa 50325 United States
Des Moines Iowa 50309 United States
Dubuque Iowa 52002 United States
Iowa City Iowa 52242 United States
Louisville Kentucky 40202 United States
Louisville Kentucky 40206-1499 United States
Bowling Green Kentucky 42101 United States
New Orleans Louisiana 70115 United States
New Orleans Louisiana 70121 United States
Hagerstown Maryland 21740 United States
Baltimore Maryland 21201 United States
Worcester Massachusetts 01608-1320 United States
Boston Massachusetts 02114 United States
Boston Massachusetts 02115 United States
Worcester Massachusetts 01655 United States
Muskegon Michigan 49444 United States
Detroit Michigan 48202 United States
Detroit Michigan 48201 United States
Rochester Minnesota 55905 United States
Ocean Springs Mississippi 39564 United States
Everton Missouri 65646 United States
Kansas City Missouri 64111 United States
St. Louis Missouri 63110 United States
Butte Montana 59701 United States
Missoula Montana 59802 United States
Lebanon New Hampshire 03756 United States
Trenton New Jersey 08629 United States
Cedar Knolls New Jersey 07927 United States
Neptune New Jersey 07753 United States
Newark New Jersey 07103 United States
New Hyde Park New York 11040 United States
Albany New York 12208 United States
Syracuse New York 13210 United States
New York New York 10016 United States
Greenville North Carolina 27834 United States
Raleigh North Carolina 27612 United States
Asheville North Carolina 28801 United States
Fargo North Dakota 58122 United States
Akron Ohio 44304 United States
Toledo Ohio 43608 United States
Centerville Ohio 45459 United States
Philadelphia Pennsylvania 19141 United States
Lancaster Pennsylvania 17602 United States
Allentown Pennsylvania 18102 United States
Philadelphia Pennsylvania 19140 United States
Pittsburgh Pennsylvania 15261 United States
Pittsburgh Pennsylvania 15212 United States
Doylestown Pennsylvania 18901 United States
Charleston South Carolina 29401 United States
Greenville South Carolina 29605 United States
Rapid City South Dakota 57701 United States
Hermitage Tennessee 37076 United States
Tyler Texas 75702 United States
Houston Texas 77030 United States
Burlington Vermont 05403 United States
Richmond Virginia 23298 United States
Danville Virginia 24541 United States
Richmond Virginia 23249 United States
Winchester Virginia 22601 United States
Tacoma Washington 98431 United States
Marshfield Wisconsin 54449 United States
Milwaukee Wisconsin 53226 United States
Eau Claire Wisconsin 54710 United States
Calgary Alberta T2N 2T9 Canada
Edmonton Alberta T5H 3V9 Canada
Vancouver British Columbia V5Z 3J5 Canada
Kelowna British Columbia V1V 1Y5 Canada
Kelowna British Columbia V1Y 1T2 & V1Y3G8 Canada
Victoria British Columbia V8R 1J8 Canada
Winnipeg Manitoba R3A 1R9 Canada
Winnipeg Manitoba R3C 0N2 Canada
Moncton New Brunswick E1C 6Z8 Canada
Saint John New Brunswick E2K 4L2 Canada
Halifax Nova Scotia B3H 2Y9 Canada
Windsor Ontario N8X 3V6 Canada
Ottawa Ontario K1H 8L6 Canada
Toronto Ontario M3N 2V6 Canada
Scarborough Ontario M1E 4B9 Canada
Thunder Bay Ontario P7B 6V1 Canada
Toronto Ontario M2K 1E1 Canada
Ajax Ontario L1S 2J5 Canada
London Ontario N6A 4G5 Canada
Toronto Ontario M4N 3M5 Canada
Peterborough Ontario K9J 7B3 Canada
Windsor Ontario N9A 1E1 Canada
Toronto Ontario M5G 2M9 & M5G 1X5 Canada
Toronto Ontario M5G 1X5 Canada
Hamilton Ontario L8N 4A6 Canada
Guelph Ontario N1E 4J4 Canada
Kingston Ontario K7L 3N6 Canada
Chicoutimi Quebec G7H 5H6 Canada
Trois Rivieres Quebec G9A 1Y1 Canada
Sainte Foy Quebec G1V 4G2 Canada
Levis Quebec G6V 3Z1 Canada
Quebec City Quebec G1L 3L5 Canada
Montreal Quebec H3G 1A4 Canada
Montreal Quebec H1T 2M4 Canada
St-Hyacinthe Quebec J2S 4Y8 Canada
St. Charles Borromee Quebec J6E 2C3 Canada
Green Field Park Quebec J4V 2H1 Canada
Montreal Quebec H3A 1A1 Canada
Quebec City Quebec G1R 2J6 Canada
Saskatoon Saskatchewan S7K 1J5 Canada
San Juan 00935 Puerto Rico
Additional Information
Information obtained from ClinicalTrials.gov on July 23, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00106509
Study ID Number: GD3-170-301
ClinicalTrials.gov Identifier: NCT00106509
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
