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Clostridium EnterocolitisPhase 3NCT00196794

A Study of GT267-004 Versus Vancomycin and GT267-004 Versus Metronidazole in Patients With C. Difficile-Associated Diarrhea

A Phase 3 study testing Tolevamer potassium-sodium (GT267-004) in people with Clostridium Enterocolitis and Diarrhea, run by Genzyme, a Sanofi Company at 138 sites in 14 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Clostridium Enterocolitis, Diarrhea
What is being tested?
Tolevamer potassium-sodium (GT267-004)
How many people
520 participants
Where
138 sitesin 14 countries
Study dates
Apr 2005to 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

  • 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.

Who cannot join

None listed.

Trial locations and contacts

138 sites in 14 countries.

138 sites in 14 countries

Spain21 sites

  • Study site

    Alcalá de Henares, 28805

  • Study site

    Badalona, 8911

  • Study site

    Badalona, 8915

  • Study site

    Barcelona, 08035

  • Study site

    Barcelona, 08036

  • Study site

    Barcelona, 8025

  • Study site

    Córdoba, 14004

  • Study site

    Donostia / San Sebastian, 20014

  • Study site

    El Palmar-Murcia, 30120

  • Study site

    Guadalajara, 19002

  • Study site

    Leganés, 28911

  • Study site

    Lleida, 25198

  • Study site

    Madrid, 28007

  • Study site

    Madrid, 28035

  • Study site

    Madrid, 28040

  • Study site

    Madrid, 28041

  • Study site

    Santander, 39008

  • Study site

    Seville, 41013

  • Study site

    Seville, 41014

  • Study site

    Seville, 41071

  • Study site

    Terrassa, 8221

Other trials in Spain

United Kingdom19 sites

  • Study site

    Abergavenny, NP7 7EG

  • Study site

    Birmingham, B15 2TT

  • Study site

    Bristol, BS16 1LE

  • Study site

    Bury, BL9 7TD

  • Study site

    Cardiff, CF14 4XW

  • Study site

    Cardiff, CF64 2XX

  • Study site

    Edinburgh, EH4 2XU

  • Study site

    Gwent, NP20 2UB

  • Study site

    Ipswich, IP4 5PD

  • Study site

    Keighley, BD20 6TD

  • Study site

    Leeds, LS1 3EX

  • Study site

    Liverpool, L7 8XP

  • Study site

    London, SE13 6LH

  • Study site

    London, W1M 3TT

  • Study site

    Salford, M6 8HD

  • Study site

    Sheffield, S10 2JF

  • Study site

    Stockport, SK2 7JE

  • Study site

    Sunderland, SR4 7TP

  • Study site

    Winchester, SO22 5DG

Other trials in United Kingdom

Australia18 sites

  • Study site

    Adelaide, 5000

  • Study site

    Bedford Park, 5042

  • Study site

    Cairns, 4870

  • Study site

    Concord, 2139

  • Study site

    Darlinghurst, 2010

  • Study site

    Five Dock, 2046

  • Study site

    Footscray, 3011

  • Study site

    Herston, 4032

  • Study site

    Hobart, 7000

  • Study site

    Kogarah, 2217

  • Study site

    Nambour, 4560

  • Study site

    Nedlands, 6009

  • Study site

    Parkville, 3050

  • Study site

    Perth, 6000

  • Study site

    Randwick, 2031

  • Study site

    South Brisbane, 4101

  • Study site

    Southport, 4215

  • Study site

    Woolloongabba, 4102

Other trials in Australia

France14 sites

  • Study site

    Amiens, 80054

  • Study site

    Annecy, 74000

  • Study site

    Clichy, 92110

  • Study site

    Créteil, 94010

  • Study site

    Dijon, 21000

  • Study site

    Garches, 92380

  • Study site

    Nice, 06200

  • Study site

    Paris, 75010

  • Study site

    Paris, 75018

  • Study site

    Paris, 75020

  • Study site

    Paris, 75679

  • Study site

    Saint-Etienne, 42055

  • Study site

    Tourcoing, 59200

  • Study site

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Germany13 sites

  • Study site

    Augsburg, 86156

  • Study site

    Berlin, 12200

  • Study site

    Cologne, 50937

  • Study site

    Düsseldorf, 40472

  • Study site

    Frankfurt, 60487

  • Study site

    Frankfurt, 60590

  • Study site

    Greifswald, 17491

  • Study site

    Hanover, 30625

  • Study site

    Hofheim, 65719

  • Study site

    Leipzig, 4157

  • Study site

    Lübeck, 23538

  • Study site

    Regensburg, 93053

  • Study site

    Wilhelmshaven, 26384

Other trials in Germany

Belgium9 sites

  • Study site

    Aalst, 9300

  • Study site

    Braine-l'Alleud, 1420

  • Study site

    Brussels, 1000

  • Study site

    Brussels, 1070

  • Study site

    Brussels, 1200

  • Study site

    Ghent, B-9000

  • Study site

    Hasselt, 3500

  • Study site

    Leuven, 3000

  • Study site

    Yvoir, B-5330

Other trials in Belgium

Sweden9 sites

  • Study site

    Gothenburg, SE-416 85

  • Study site

    Jönköping, SE-551 85

  • Study site

    Kalmar, SE-391 85

  • Study site

    Karlskrona, SE-371 85

  • Study site

    Kristianstad, SE-291 85

  • Study site

    Lund, SE-221 85

  • Study site

    Malmö, SE-205 85

  • Study site

    Örebro, SE-701 85

  • Study site

    Skövde, SE-541 85

Other trials in Sweden

Norway8 sites

  • Study site

    Bergen, N-5009

  • Study site

    Bergen, N-5021

  • Study site

    Bodø, N-8005

  • Study site

    Oslo, N-0407

  • Study site

    Stavanger, N-4068

  • Study site

    Tønsberg, 3103

  • Study site

    Tromsø, 9038

  • Study site

    Trondheim, 7006

Other trials in Norway

Czechia6 sites

  • Study site

    Brno, 62500

  • Study site

    Hradec Králové, 50005

  • Study site

    Mělník, 276 01

  • Study site

    Ostrava, 708 52

  • Study site

    Prague, 128 20

  • Study site

    Prague, 180 81

Other trials in Czechia

Austria5 sites

  • Study site

    Innsbruck, 6020

  • Study site

    Linz, 4010

  • Study site

    Linz, 4020

  • Study site

    Oberndorf, 5110

  • Study site

    Salzburg, 5020

Other trials in Austria

Switzerland5 sites

  • Study site

    Baden, 5404

  • Study site

    Basel, 4031

  • Study site

    Bellinzona, 6500

  • Study site

    Geneva, 1211

  • Study site

    Lugano, 6903

Other trials in Switzerland

Denmark4 sites

  • Study site

    Copenhagen, DK-2200

  • Study site

    Copenhagen, DK-2400

  • Study site

    Herlev, DK-2730

  • Study site

    Hvidovre, DK-2650

Other trials in Denmark

Portugal4 sites

  • Study site

    Carnaxide, 2790-134

  • Study site

    Coimbra, 3000-075

  • Study site

    Matosinhos Municipality, 4450

  • Study site

    Porto, 4099-001

Other trials in Portugal

Ireland3 sites

  • Study site

    Castlebar

  • Study site

    Cork

  • Study site

    Dublin

Other trials in Ireland

About this study

Official title: A Randomized, Double-Blind Study of GT267-004 Versus Vancomycin, and GT267-004 Versus Metronidazole in Patients With C. Difficile-Associated Diarrhea

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.

Being tested
Tolevamer potassium-sodium (GT267-004)
Keywords
Pseudomembranous Colitis, Clostridium difficile-associated diarrhea, C. difficile, CDAD
Medical subject headings
Enterocolitis, Pseudomembranous, Diarrhea

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.

  1. Resolution of diarrhea

Secondary outcomes (5)

  1. Time to resolution of diarrhea

  2. Recurrence rate

  3. Number of stools

  4. Average stool consistency

  5. Treatment success

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Sep 2005 (estimated)
  2. Study startApr 2005
  3. Study completionAug 2007

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
520 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00196794
Sponsor's protocol ID
GD3-170-302
Status last verified
Mar 2014
First submitted
13 Sep 2005
Last updated
19 Mar 2014
Results posted
No

Publications

  • 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.

    PubMed 24799326

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tolevamer potassium-sodium (GT267-004) in people with Clostridium Enterocolitis and Diarrhea, run by Genzyme, a Sanofi Company at 138 sites in 14 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 19 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 138 sites in Spain, United Kingdom, Australia, France, Germany and 9 more countries. 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 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?

Resolution of diarrhea. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00196794, which also lists 1 linked publication.

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 2014.

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