Enterocolitis, PseudomembranousPhase 3NCT00466635
A Study to Assess the Safety, Tolerability, Effectiveness and Absorption of Exodif™ Tablets in Clostridium Difficile-associated Diarrhea
A Phase 3 study testing GT267-004 (tolevamer potassium sodium) in people with Enterocolitis, Pseudomembranous and Diarrhea, run by Genzyme, a Sanofi Company at 13 sites in United States.
Trial summary
Approximately 65 patients will be entered into this study taking place in North America. The aim of this study is to evaluate the safety, efficacy and absorption of an investigational drug in patients with C. difficile-associated diarrhea (CDAD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Enterocolitis, Pseudomembranous, Diarrhea, Clostridium Difficile
- What is being tested?
- GT267-004 (tolevamer potassium sodium)
- How many people
- 65 participants
- Where
- 13 sitesUnited States
- Study dates
- Apr 2007to Aug 2007
- Phase
- Phase 3
- 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
- The presence of CDAD at the time of enrollment
- Negative serum pregnancy test (HCG) for women of childbearing potential.
Who cannot join
- Any contraindication to oral / enteral therapy including fulminant C. difficile disease.
- Any acutely life-threatening medical conditions.
- Acute or chronic diarrhea of other cause.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Study site
Baltimore, Maryland
Study site
Butte, Montana
Study site
Cedar Knolls, New Jersey
Study site
Greenville, North Carolina
Study site
Honolulu, Hawaii
Study site
Lancaster, Pennsylvania
Study site
Maywood, Illinois
Study site
Modesto, California
Study site
Neptune City, New Jersey
Study site
Syracuse, New York
Study site
Toledo, Ohio
Study site
West Bloomfield, Michigan
Study site
Worcester, Massachusetts
About this study
Official title: An Open-label Study to Assess the Safety, Efficacy and Absorption of Exodif™ (Tolevamer Potassium Sodium) Tablets in Patients With Clostridium Difficile-Associated Diarrhea
Approximately 65 patients will be entered into this study taking place in North America. The aim of this study is to evaluate the safety, efficacy and absorption of an investigational drug in patients with C. difficile-associated diarrhea (CDAD). All study related care is provided including doctor visits, physical exams, laboratory tests and study medication. Total length of participation is 6 weeks.
- Being tested
- GT267-004 (tolevamer potassium sodium)
- Keywords
- Clostridium difficile Disease, Infectious diarrhea, C. difficile, CDAD, Clostridium difficile-associated diarrhea, Clostridium difficile diarrhea, Antibiotic-Associated Colitis, Clostridium Enterocolitis, Antibiotic-Associated Diarrhea, Pseudomembranous Colitis, Clostridium difficile
- Medical subject headings
- Enterocolitis, Pseudomembranous, Diarrhea, Dysentery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GT267-004 (tolevamer potassium sodium)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Success
Safety
Secondary outcomes (1)
The extent of tolevamer absorption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2007 (estimated)
- Study startApr 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enterocolitis, PseudomembranousStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genzyme, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, Study director, Genzyme, a Sanofi Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00466635
- Sponsor's protocol ID
- TOL26700706
- Status last verified
- Mar 2015
- First submitted
- 25 Apr 2007
- Last updated
- 19 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Study to Assess the Safety, Efficacy and Absorption of Exodif™ (Tolevamer Potassium Sodium) Tablets in Patients With Clostridium Difficile-Associated Diarrhea
- ClinicalTrials.gov ID
- NCT00466635
- Acronym / sponsor ID
- TOL26700706
- Keywords
- Clostridium difficile Disease, Infectious diarrhea, C. difficile, CDAD, Clostridium difficile-associated diarrhea, Clostridium difficile diarrhea, Antibiotic-Associated Colitis, Clostridium Enterocolitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- Study completion
- Aug 2007 (actual)
- First posted
- 27 Apr 2007 (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 65 patients will be entered into this study taking place in North America. The aim of this study is to evaluate the safety, efficacy and absorption of an investigational drug in patients with C. difficile-associated diarrhea (CDAD). All study related care is provided including doctor visits, physical exams, laboratory tests and study medication. Total length of participation is 6 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- The presence of CDAD at the time of enrollment
- Negative serum pregnancy test (HCG) for women of childbearing potential.
Key exclusion criteria (3 listed)
- Any contraindication to oral / enteral therapy including fulminant C. difficile disease.
- Any acutely life-threatening medical conditions.
- Acute or chronic diarrhea of other cause.
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 |
|---|---|---|
| GT267-004 (tolevamer potassium sodium) | Drug | – |
Primary outcome
Clinical Success
Safety
1 secondary outcome
The extent of tolevamer absorption
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2015.
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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
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GT267-004 (tolevamer potassium sodium) in people with Enterocolitis, Pseudomembranous and Diarrhea, run by Genzyme, a Sanofi Company at 13 sites in United States.
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 2 inclusion and 3 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: stopped early, as of the sponsor's last update on 19 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 13 sites in United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early. Results are not available in the source record.
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.
What does the primary outcome measure?
Clinical Success. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 19 Mar 2015; AzTrials last refreshed its copy on 26 Oct 2026.