Clostridium Difficile-Associated DiarrheaPhase 2NCT00034294
A Study of GT160-246 Versus Vancomycin in Patients With Clostridium Difficile-Associated Diarrhea
A Phase 2 study testing GT160-246 in people with Clostridium Difficile-Associated Diarrhea and Clostridium Enterocolitis, run by Genzyme, a Sanofi Company at 99 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clostridium Difficile-Associated Diarrhea, Clostridium Enterocolitis, Clostridium Difficile Diarrhea
- What is being tested?
- GT160-246
- How many people
- 300 participants
- Where
- 99 sitesin 4 countries
- Study dates
- Feb 2002to Jul 2003
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
99 sites in 4 countries.
99 sites in 4 countries
United States58 sites
Study site
Allentown, Pennsylvania, 18105
Study site
Asheville, North Carolina, 28801
Study site
Austell, Georgia, 30106
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Baltimore, Maryland, 21215
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Bay Pines, Florida, 33744
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Boston, Massachusetts, 02111
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Braintree, Massachusetts, 02185
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Brandon, Florida, 33511
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Buffalo, New York, 14215
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Charleston, South Carolina, 29425
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Charlotte, North Carolina, 28203
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Chevy Chase, Maryland, 20815
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Chicago, Illinois, 60611
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Clarksville, Tennessee, 37043
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Columbus, Georgia, 31902
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Columbus, Indiana, 47203
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Columbus, Ohio, 43215
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Des Moines, Iowa, 50309
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Des Moines, Iowa, 50314
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Falls Church, Virginia, 22042
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Fargo, North Dakota, 58122
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Hershey, Pennsylvania, 17033
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Hollywood, Florida, 33021
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Jamaica, New York, 11432
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Lexington, Kentucky, 40536-0084
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Little Rock, Arkansas, 72205
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Louisville, Kentucky, 40202
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Manhasset, New York, 11030
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Maywood, Illinois, 60153
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Memphis, Tennessee, 38104
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Mobile, Alabama, 36617
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Naples, Florida, 34102
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New Orleans, Louisiana, 70112
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New York, New York, 10010
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New York, New York, 10032
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Newark, Delaware, 19718
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North Chicago, Illinois, 60064
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Oklahoma City, Oklahoma, 73104
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Orlando, Florida, 32806
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Philadelphia, Pennsylvania, 19102
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Philadelphia, Pennsylvania, 19129
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Philadelphia, Pennsylvania, 19140
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Phoenix, Arizona, 85006
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Pittsburgh, Pennsylvania, 15261
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Richmond, Virginia, 23249
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Richmond, Virginia, 23294
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Sacramento, California, 95816
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Seattle, Washington, 98104
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Springfield, Missouri, 65807
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St Louis, Missouri, 63110
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Stratford, New Jersey, 08084
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Syracuse, New York, 13210
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Temple, Texas, 76508
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Toledo, Ohio, 43608
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Tucson, Arizona, 85724
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Upland, Pennsylvania, 19013
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West Roxbury, Massachusetts, 02132
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Wichita, Kansas, 67214
United Kingdom27 sites
Study site
Birmingham, B18 7QH
Study site
Birmingham, B95SS
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Bury, Lancashire, BL9 7TD
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Cambridge, CB2 2QQ
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Chelsea, London, SW10 9NH
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Cliftonville, Northampton, NN1 5BD
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Edinburgh, EH4 2XU
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Fulwood, Preston, PR7 1PP
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Glasgow, G21 3UR
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Heathpark, Cardiff, CF4 4XW
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High Heaton, Newcastle-upon-Tyne, NE7 7DN
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Hull, HU3 2JZ
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Leeds, LS1 3EX
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Leicester, LE1 5WW
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Livilands, Stirling, FK8 2AU
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London, N19 5LW
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London, SW17 0QT
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London, W1N 8AA
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Morriston, Swansea, SA6 6NL
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Newport, NP20 2UB
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Nottingham, NG7 2UH
Study site
Penlan Rd, Cardiff, CF64 2XX
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Shrewsbury, SY3 8XQ
Study site
South Kensington, London, SW7 2AZ
Study site
Steeton, Keighley, BD20 6TD
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Taunton, TA1 5DA
Study site
Wolverhampton, WV10 0QP
Canada13 sites
Study site
Calgary, Alberta, T2N 1T9
Study site
Chicoutimi, Quebec, G7H 5H6
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Moncton, New Brunswick, E1C 6Z8
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Montreal, Quebec, H1T 2M4
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Montreal, Quebec, H2L 4M1
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Montreal, Quebec, H3T 1E2
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Ottawa, Ontario, K1H 8L6
Study site
Québec, Quebec, G1R 2J6 and G1L 3L5
Study site
Trois-Rivières, Quebec, G9A 1Y1
Study site
Vancouver, British Columbia, V5Z 3J5
Study site
Vancouver, British Columbia, V6Z 1Y6
Study site
Windsor, Ontario, N9A 1C9
Study site
Winnipeg, Manitoba, R3A 1R9
About this study
Official title: A Randomized, Double-Blind Study of GT160-246 Versus Vancomycin in Patients With C. Difficile-Associated Diarrhea
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.
- Conditions
- Clostridium Difficile-Associated Diarrhea, Clostridium Enterocolitis, Clostridium Difficile Diarrhea, Antibiotic-associated Colitis, Antibiotic-associated Diarrhea
- Being tested
- GT160-246
- 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
- Medical subject headings
- Enterocolitis, Pseudomembranous, Dysentery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GT160-246Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2002 (estimated)
- Study startFeb 2002
- Study completionJul 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clostridium Difficile-Associated DiarrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- Genzyme, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Genzyme, a Sanofi Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00034294
- Sponsor's protocol ID
- GTC-80-203
- Other IDs
- GT1105
- Status last verified
- Mar 2015
- First submitted
- 24 Apr 2002
- Last updated
- 5 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind Study of GT160-246 Versus Vancomycin in Patients With C. Difficile-Associated Diarrhea
- ClinicalTrials.gov ID
- NCT00034294
- Acronym / sponsor ID
- GTC-80-203
- Conditions
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Feb 2002
- Study completion
- Jul 2003 (actual)
- First posted
- 25 Apr 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GT160-246 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2015.
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RecruitingObservational study
Rescue Fecal Microbiota Transplantation for National Refractory Intestinal Infections
Intestinal Infection, Clostridioides Difficile Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor study director
Genzyme, a Sanofi Company
99 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GT160-246 in people with Clostridium Difficile-Associated Diarrhea and Clostridium Enterocolitis, run by Genzyme, a Sanofi Company at 99 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 99 sites in United States, United Kingdom, Canada, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2015; AzTrials last refreshed its copy on 7 Nov 2026.