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

Primary Purpose

Clostridium Difficile-Associated Diarrhea, Clostridium Enterocolitis, Clostridium Difficile Diarrhea

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
GT160-246
Sponsored by
Genzyme, a Sanofi Company
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Clostridium Difficile-Associated Diarrhea focused on measuring C. difficile-associated diarrhea, CDAD, Clostridium difficile-Associated Diarrhea, Clostridium enterocolitis, antibiotic-associated diarrhea, clostridium difficile colitis, infectious diarrhea, chronic diarrhea, antibiotic-associated colitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 24, 2002
Last Updated
March 4, 2015
Sponsor
Genzyme, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT00034294
Brief Title
A Study of GT160-246 Versus Vancomycin in Patients With Clostridium Difficile-Associated Diarrhea
Official Title
A Randomized, Double-Blind Study of GT160-246 Versus Vancomycin in Patients With C. Difficile-Associated Diarrhea
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
February 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genzyme, a Sanofi Company

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clostridium Difficile-Associated Diarrhea, Clostridium Enterocolitis, Clostridium Difficile Diarrhea, Antibiotic-associated Colitis, Antibiotic-associated Diarrhea
Keywords
C. difficile-associated diarrhea, CDAD, Clostridium difficile-Associated Diarrhea, Clostridium enterocolitis, antibiotic-associated diarrhea, clostridium difficile colitis, infectious diarrhea, chronic diarrhea, antibiotic-associated colitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
300 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
GT160-246

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Genzyme, a Sanofi Company
Official's Role
Study Director
Facility Information:
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36617
Country
United States
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
City
Newark
State/Province
Delaware
ZIP/Postal Code
19718
Country
United States
City
Bay Pines
State/Province
Florida
ZIP/Postal Code
33744
Country
United States
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
City
Austell
State/Province
Georgia
ZIP/Postal Code
30106
Country
United States
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31902
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
City
North Chicago
State/Province
Illinois
ZIP/Postal Code
60064
Country
United States
City
Columbus
State/Province
Indiana
ZIP/Postal Code
47203
Country
United States
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536-0084
Country
United States
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
City
Braintree
State/Province
Massachusetts
ZIP/Postal Code
02185
Country
United States
City
West Roxbury
State/Province
Massachusetts
ZIP/Postal Code
02132
Country
United States
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
City
Stratford
State/Province
New Jersey
ZIP/Postal Code
08084
Country
United States
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
City
Jamaica
State/Province
New York
ZIP/Postal Code
11432
Country
United States
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10010
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43608
Country
United States
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18105
Country
United States
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19129
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15261
Country
United States
City
Upland
State/Province
Pennsylvania
ZIP/Postal Code
19013
Country
United States
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
City
Clarksville
State/Province
Tennessee
ZIP/Postal Code
37043
Country
United States
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 1T9
Country
Canada
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 3J5
Country
Canada
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1R9
Country
Canada
City
Moncton
State/Province
New Brunswick
ZIP/Postal Code
E1C 6Z8
Country
Canada
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N9A 1C9
Country
Canada
City
Chicoutimi
State/Province
Quebec
ZIP/Postal Code
G7H 5H6
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
City
Trois-Rivieres
State/Province
Quebec
ZIP/Postal Code
G9A 1Y1
Country
Canada
City
Quebec
ZIP/Postal Code
G1R 2J6 and G1L 3L5
Country
Canada
City
Hato Rey
ZIP/Postal Code
00918
Country
Puerto Rico
City
Heath Park
State/Province
Cardiff
ZIP/Postal Code
CF4 4XW
Country
United Kingdom
City
Penlan Rd
State/Province
Cardiff
ZIP/Postal Code
CF64 2XX
Country
United Kingdom
City
Steeton
State/Province
Keighley
ZIP/Postal Code
BD20 6TD
Country
United Kingdom
City
Bury
State/Province
Lancashire
ZIP/Postal Code
BL9 7TD
Country
United Kingdom
City
Chelsea
State/Province
London
ZIP/Postal Code
SW10 9NH
Country
United Kingdom
City
South Kensington
State/Province
London
ZIP/Postal Code
SW7 2AZ
Country
United Kingdom
City
High Heaton
State/Province
Newcastle-upon-Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
City
Cliftonville
State/Province
Northampton
ZIP/Postal Code
NN1 5BD
Country
United Kingdom
City
Fulwood
State/Province
Preston
ZIP/Postal Code
PR7 1PP
Country
United Kingdom
City
Livilands
State/Province
Stirling
ZIP/Postal Code
FK8 2AU
Country
United Kingdom
City
Morriston
State/Province
Swansea
ZIP/Postal Code
SA6 6NL
Country
United Kingdom
City
Birmingham
ZIP/Postal Code
B18 7QH
Country
United Kingdom
City
Birmingham
ZIP/Postal Code
B95SS
Country
United Kingdom
City
Cambridge
ZIP/Postal Code
CB2 2QQ
Country
United Kingdom
City
Edinburgh
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
City
Glasgow
ZIP/Postal Code
G21 3UR
Country
United Kingdom
City
Hull
ZIP/Postal Code
HU3 2JZ
Country
United Kingdom
City
Leeds
ZIP/Postal Code
LS1 3EX
Country
United Kingdom
City
Leicester
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
City
London
ZIP/Postal Code
N19 5LW
Country
United Kingdom
City
London
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
City
London
ZIP/Postal Code
W1N 8AA
Country
United Kingdom
City
Newport
ZIP/Postal Code
NP20 2UB
Country
United Kingdom
City
Nottingham
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
City
Shrewsbury
ZIP/Postal Code
SY3 8XQ
Country
United Kingdom
City
Taunton
ZIP/Postal Code
TA1 5DA
Country
United Kingdom
City
Wolverhampton
ZIP/Postal Code
WV10 0QP
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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