Pseudomembranous ColitisPhase 2NCT00382304
A Study of the Absorption of GT267-004 in Patients With Clostridium Difficile-Associated Diarrhea
A Phase 2 study testing tolevamer potassium-sodium (GT267-004) in people with Pseudomembranous Colitis and Clostridium Difficile Diarrhea, run by Genzyme, a Sanofi Company at 8 sites in Canada.
Trial summary
Approximately 24 patients will be entered into this study taking place in Canada. The aim of this study is to determine if an investigational drug is absorbed (taken up) 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
- Pseudomembranous Colitis, Clostridium Difficile Diarrhea, Antibiotic-Associated Diarrhea
- What is being tested?
- tolevamer potassium-sodium (GT267-004)
- How many people
- 24 participants
- Where
- 8 sitesCanada
- Study dates
- Sep 2006to Sep 2007
- 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
- 18 years of age or older
- The presence of CDAD at the time of enrollment with no other likely etiology for the diarrhea
Who cannot join
- > 72 hours of treatment with metronidazole, vancomycin, or other antibacterial therapy specifically targeting the current acute episode of CDAD
- Patient not considered sufficiently stable clinically to complete the study period
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Canada8 sites
Study site
Edmonton, Alberta, T6G 2B7
Study site
Montreal, Quebec, H3T 1E2
Study site
Nanaimo, British Columbia, V9S 2B7
Study site
Ottowa, Ontario, K1H 8L6
Study site
Richmond Hill, Ontario, L4C 4Z3
Study site
Rimouski, Quebec, G5L 5T1
Study site
Sherbrooke, Quebec, J1H 5N4
Study site
Vancouver, British Columbia, V3Z 1M9
About this study
Official title: A Study of the Pharmacokinetics of GT267-004 in Patients With Clostridium Difficile-Associated Diarrhea
Approximately 24 patients will be entered into this study taking place in Canada. The aim of this study is to determine if an investigational drug is absorbed (taken up) in patients with C. difficile-associated diarrhea (CDAD). The investigational drug will be given in addition to current standard antibiotic treatment so that 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 7 days.
- Being tested
- tolevamer potassium-sodium (GT267-004)
- Keywords
- Clostridium difficile-associated diarrhea, C. difficile, CDAD, Clostridium difficile, Clostridium difficile Disease, Clostridium Enterocolitis, Antibiotic-Associated Colitis, Infectious diarrhea
- 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.
tolevamer potassium-sodium (GT267-004)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
The extent of GT267-004 absorption as measured in the blood and urine by pharmacokinetic analysis
Secondary outcomes (1)
Safety as measured by physical examinations (including vital signs), adverse events and changes in safety laboratory values
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2006 (estimated)
- Study startSep 2006
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pseudomembranous ColitisStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 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
- NCT00382304
- Sponsor's protocol ID
- TOL26700606
- Status last verified
- Mar 2015
- First submitted
- 27 Sep 2006
- 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
- A Study of the Pharmacokinetics of GT267-004 in Patients With Clostridium Difficile-Associated Diarrhea
- ClinicalTrials.gov ID
- NCT00382304
- Acronym / sponsor ID
- TOL26700606
- Keywords
- Clostridium difficile-associated diarrhea, C. difficile, CDAD, Clostridium difficile, Clostridium difficile Disease, Clostridium Enterocolitis, Antibiotic-Associated Colitis, Infectious diarrhea
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Study completion
- Sep 2007 (actual)
- First posted
- 29 Sep 2006 (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 24 patients will be entered into this study taking place in Canada. The aim of this study is to determine if an investigational drug is absorbed (taken up) in patients with C. difficile-associated diarrhea (CDAD). The investigational drug will be given in addition to current standard antibiotic treatment so that 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 7 days.
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)
- 18 years of age or older
- The presence of CDAD at the time of enrollment with no other likely etiology for the diarrhea
Key exclusion criteria (2 listed)
- > 72 hours of treatment with metronidazole, vancomycin, or other antibacterial therapy specifically targeting the current acute episode of CDAD
- Patient not considered sufficiently stable clinically to complete the study period
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 |
|---|---|---|
| tolevamer potassium-sodium (GT267-004) | Drug | – |
Primary outcome
The extent of GT267-004 absorption as measured in the blood and urine by pharmacokinetic analysis
1 secondary outcome
Safety as measured by physical examinations (including vital signs), adverse events and changes in safety laboratory values
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 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
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing tolevamer potassium-sodium (GT267-004) in people with Pseudomembranous Colitis and Clostridium Difficile Diarrhea, run by Genzyme, a Sanofi Company at 8 sites in Canada.
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 2 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 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 8 sites in Canada. 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.
What does the primary outcome measure?
The extent of GT267-004 absorption as measured in the blood and urine by pharmacokinetic analysis. 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.