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

Information source: Genzyme
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Clostridium Enterocolitis; Pseudomembranous Colitis

Intervention: tolevamer potassium-sodium (GT267-004) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Genzyme

Summary

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.

Clinical Details

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

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Resolution of diarrhea

Secondary outcome:

Time to resolution of diarrhea

Recurrence rate

Number of stools

Average stool consistency

Treatment success

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

San Juan 00935, Puerto Rico

Calgary, Alberta T2N 2T9, Canada

Edmonton, Alberta T5H 3V9, Canada

Phoenix, Arizona 85006, United States

Phoenix, Arizona 85012, United States

Rogers, Arkansas 72756, United States

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

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

Winnipeg, Manitoba R3A 1R9, Canada

Winnipeg, Manitoba R3C 0N2, Canada

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

Moncton, New Brunswick E1C 6Z8, Canada

Saint John, New Brunswick E2K 4L2, Canada

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

Halifax, Nova Scotia B3H 2Y9, Canada

Akron, Ohio 44304, United States

Toledo, Ohio 43608, United States

Centerville, Ohio 45459, United States

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

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

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

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

Additional Information

Starting date: March 2005
Last updated: April 29, 2007

Page last updated: June 20, 2008

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