Back to resultsA Study of GT267-004 Versus Vancomycin and GT267-004 Versus Metronidazole in Patients With C. Difficile-Associated Diarrhea
Primary Purpose
Clostridium Enterocolitis, Diarrhea
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Tolevamer potassium-sodium (GT267-004)
Sponsored by
About this trial
This is an interventional treatment trial for Clostridium Enterocolitis focused on measuring Pseudomembranous Colitis, Clostridium difficile-associated diarrhea, C. difficile, CDAD
Eligibility Criteria
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.
Sites / Locations
Outcomes
Primary Outcome Measures
Resolution of diarrhea
Secondary Outcome Measures
Time to resolution of diarrhea
Recurrence rate
Number of stools
Average stool consistency
Treatment success
Full Information
NCT ID
NCT00196794
First Posted
September 13, 2005
Last Updated
March 17, 2014
Sponsor
Genzyme, a Sanofi Company
1. Study Identification
Unique Protocol Identification Number
NCT00196794
Brief Title
A Study of GT267-004 Versus Vancomycin and GT267-004 Versus Metronidazole in Patients With C. Difficile-Associated Diarrhea
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 Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Genzyme, a Sanofi Company
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clostridium Enterocolitis, Diarrhea
Keywords
Pseudomembranous Colitis, Clostridium difficile-associated diarrhea, C. difficile, CDAD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
520 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Tolevamer potassium-sodium (GT267-004)
Primary Outcome Measure Information:
Title
Resolution of diarrhea
Secondary Outcome Measure Information:
Title
Time to resolution of diarrhea
Title
Recurrence rate
Title
Number of stools
Title
Average stool consistency
Title
Treatment success
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
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
Adelaide
ZIP/Postal Code
5000
Country
Australia
City
Bedford Park
ZIP/Postal Code
5042
Country
Australia
City
Cairns
ZIP/Postal Code
4870
Country
Australia
City
Concord
ZIP/Postal Code
2139
Country
Australia
City
Darlinghurst
ZIP/Postal Code
2010
Country
Australia
City
Five Dock
ZIP/Postal Code
2046
Country
Australia
City
Footscray
ZIP/Postal Code
3011
Country
Australia
City
Herston
ZIP/Postal Code
4032
Country
Australia
City
Hobart
ZIP/Postal Code
7000
Country
Australia
City
Kogarah
ZIP/Postal Code
2217
Country
Australia
City
Nambour
ZIP/Postal Code
4560
Country
Australia
City
Nedlands
ZIP/Postal Code
6009
Country
Australia
City
Parkville
ZIP/Postal Code
3050
Country
Australia
City
Perth
ZIP/Postal Code
6000
Country
Australia
City
Randwick
ZIP/Postal Code
2031
Country
Australia
City
South Brisbane
ZIP/Postal Code
4101
Country
Australia
City
Southport
ZIP/Postal Code
4215
Country
Australia
City
Woolloongabba
ZIP/Postal Code
4102
Country
Australia
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
City
Linz
ZIP/Postal Code
4010
Country
Austria
City
Linz
ZIP/Postal Code
4020
Country
Austria
City
Oberndorf
ZIP/Postal Code
5110
Country
Austria
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
City
Braine L'Alleud
ZIP/Postal Code
1420
Country
Belgium
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
City
Gent
ZIP/Postal Code
B-9000
Country
Belgium
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
City
Yvoir
ZIP/Postal Code
B-5330
Country
Belgium
City
Brno
ZIP/Postal Code
62500
Country
Czech Republic
City
Hradec Kralove
ZIP/Postal Code
50005
Country
Czech Republic
City
Melnik
ZIP/Postal Code
276 01
Country
Czech Republic
City
Ostrava
ZIP/Postal Code
708 52
Country
Czech Republic
City
Praha
ZIP/Postal Code
128 20
Country
Czech Republic
City
Praha
ZIP/Postal Code
180 81
Country
Czech Republic
City
Copenhagen
ZIP/Postal Code
DK-2200
Country
Denmark
City
Copenhagen
ZIP/Postal Code
DK-2400
Country
Denmark
City
Herlev
ZIP/Postal Code
DK-2730
Country
Denmark
City
Hvidovre
ZIP/Postal Code
DK-2650
Country
Denmark
City
Amiens
ZIP/Postal Code
80054
Country
France
City
Annecy
ZIP/Postal Code
74000
Country
France
City
Clichy
ZIP/Postal Code
92110
Country
France
City
Creteil
ZIP/Postal Code
94010
Country
France
City
Dijon
ZIP/Postal Code
21000
Country
France
City
Garches
ZIP/Postal Code
92380
Country
France
City
Nice
ZIP/Postal Code
06200
Country
France
City
Paris
ZIP/Postal Code
75010
Country
France
City
Paris
ZIP/Postal Code
75018
Country
France
City
Paris
ZIP/Postal Code
75020
Country
France
City
Paris
ZIP/Postal Code
75679
Country
France
City
Saint Etienne
ZIP/Postal Code
42055
Country
France
City
Tourcoing
ZIP/Postal Code
59200
Country
France
City
Vandoeuvre-les-Nancy
ZIP/Postal Code
54511
Country
France
City
Augsburg
ZIP/Postal Code
86156
Country
Germany
City
Berlin
ZIP/Postal Code
12200
Country
Germany
City
Düsseldorf
ZIP/Postal Code
40472
Country
Germany
City
Frankfurt
ZIP/Postal Code
60487
Country
Germany
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
City
Greifswald
ZIP/Postal Code
17491
Country
Germany
City
Hannover
ZIP/Postal Code
30625
Country
Germany
City
Hofheim
ZIP/Postal Code
65719
Country
Germany
City
Köln
ZIP/Postal Code
50937
Country
Germany
City
Leipzig
ZIP/Postal Code
4157
Country
Germany
City
Lübeck
ZIP/Postal Code
23538
Country
Germany
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
City
Wilhelmshaven
ZIP/Postal Code
26384
Country
Germany
City
Castlebar
Country
Ireland
City
Cork
Country
Ireland
City
Dublin
Country
Ireland
City
Bergen
ZIP/Postal Code
N-5009
Country
Norway
City
Bergen
ZIP/Postal Code
N-5021
Country
Norway
City
Bodo
ZIP/Postal Code
N-8005
Country
Norway
City
Oslo
ZIP/Postal Code
N-0407
Country
Norway
City
Stavanger
ZIP/Postal Code
N-4068
Country
Norway
City
Tonsberg
ZIP/Postal Code
3103
Country
Norway
City
Tromso
ZIP/Postal Code
9038
Country
Norway
City
Trondheim
ZIP/Postal Code
7006
Country
Norway
City
Carnaxide
ZIP/Postal Code
2790-134
Country
Portugal
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
City
Matosinhos
ZIP/Postal Code
4450
Country
Portugal
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
City
Alcala de Henares
ZIP/Postal Code
28805
Country
Spain
City
Badalona
ZIP/Postal Code
8911
Country
Spain
City
Badalona
ZIP/Postal Code
8915
Country
Spain
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
City
Barcelona
ZIP/Postal Code
8025
Country
Spain
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
City
El Palmar-Murcia
ZIP/Postal Code
30120
Country
Spain
City
Guadalajara
ZIP/Postal Code
19002
Country
Spain
City
Leganes
ZIP/Postal Code
28911
Country
Spain
City
Lleida
ZIP/Postal Code
25198
Country
Spain
City
Madrid
ZIP/Postal Code
28007
Country
Spain
City
Madrid
ZIP/Postal Code
28035
Country
Spain
City
Madrid
ZIP/Postal Code
28040
Country
Spain
City
Madrid
ZIP/Postal Code
28041
Country
Spain
City
San Sebastian
ZIP/Postal Code
20014
Country
Spain
City
Santander
ZIP/Postal Code
39008
Country
Spain
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
City
Sevilla
ZIP/Postal Code
41071
Country
Spain
City
Terrassa
ZIP/Postal Code
8221
Country
Spain
City
Goteborg
ZIP/Postal Code
SE-416 85
Country
Sweden
City
Joenkoeping
ZIP/Postal Code
SE-551 85
Country
Sweden
City
Kalmar
ZIP/Postal Code
SE-391 85
Country
Sweden
City
Karlskrona
ZIP/Postal Code
SE-371 85
Country
Sweden
City
Kristianstad
ZIP/Postal Code
SE-291 85
Country
Sweden
City
Lund
ZIP/Postal Code
SE-221 85
Country
Sweden
City
Malmö
ZIP/Postal Code
SE-205 85
Country
Sweden
City
Oerebro
ZIP/Postal Code
SE-701 85
Country
Sweden
City
Skoevde
ZIP/Postal Code
SE-541 85
Country
Sweden
City
Baden
ZIP/Postal Code
5404
Country
Switzerland
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
City
Bellinzona
ZIP/Postal Code
6500
Country
Switzerland
City
Geneva
ZIP/Postal Code
1211
Country
Switzerland
City
Lugano
ZIP/Postal Code
6903
Country
Switzerland
City
Abergavenny
ZIP/Postal Code
NP7 7EG
Country
United Kingdom
City
Birmingham
ZIP/Postal Code
B15 2TT
Country
United Kingdom
City
Bristol
ZIP/Postal Code
BS16 1LE
Country
United Kingdom
City
Bury
ZIP/Postal Code
BL9 7TD
Country
United Kingdom
City
Cardiff
ZIP/Postal Code
CF14 4XW
Country
United Kingdom
City
Cardiff
ZIP/Postal Code
CF64 2XX
Country
United Kingdom
City
Edinburgh
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
City
Gwent
ZIP/Postal Code
NP20 2UB
Country
United Kingdom
City
Ipswich
ZIP/Postal Code
IP4 5PD
Country
United Kingdom
City
Keighley
ZIP/Postal Code
BD20 6TD
Country
United Kingdom
City
Leeds
ZIP/Postal Code
LS1 3EX
Country
United Kingdom
City
Liverpool
ZIP/Postal Code
L7 8XP
Country
United Kingdom
City
London
ZIP/Postal Code
SE13 6LH
Country
United Kingdom
City
London
ZIP/Postal Code
W1M 3TT
Country
United Kingdom
City
Salford
ZIP/Postal Code
M6 8HD
Country
United Kingdom
City
Sheffield
ZIP/Postal Code
S10 2JF
Country
United Kingdom
City
Stockport
ZIP/Postal Code
SK2 7JE
Country
United Kingdom
City
Sunderland
ZIP/Postal Code
SR4 7TP
Country
United Kingdom
City
Winchester
ZIP/Postal Code
SO22 5DG
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
24799326
Citation
Johnson S, Louie TJ, Gerding DN, Cornely OA, Chasan-Taber S, Fitts D, Gelone SP, Broom C, Davidson DM; Polymer Alternative for CDI Treatment (PACT) investigators. Vancomycin, metronidazole, or tolevamer for Clostridium difficile infection: results from two multinational, randomized, controlled trials. Clin Infect Dis. 2014 Aug 1;59(3):345-54. doi: 10.1093/cid/ciu313. Epub 2014 May 5.
Results Reference
derived
Learn more about this trial
A Study of GT267-004 Versus Vancomycin and GT267-004 Versus Metronidazole in Patients With C. Difficile-Associated Diarrhea
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