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Clostridium EnterocolitisPhase 3NCT00106509

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 Pseudomembranous Colitis, run by Genzyme, a Sanofi Company at 140 sites in 3 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 the US and Canada. 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
What is being tested?
tolevamer potassium-sodium (GT267-004)
How many people
520 participants
Where
140 sitesin 3 countries
Study dates
Mar 2005to Feb 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
  • 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 a 6 week study period

Who cannot join

None listed.

Trial locations and contacts

140 sites in 3 countries.

140 sites in 3 countries

United States99 sites

  • Study site

    Akron, Ohio, 44304

  • Study site

    Albany, New York, 12208

  • Study site

    Allentown, Pennsylvania, 18102

  • Study site

    Anderson, Indiana, 46011

  • Study site

    Asheville, North Carolina, 28801

  • Study site

    Atlanta, Georgia, 30309

  • Study site

    Baltimore, Maryland, 21201

  • Study site

    Bay Pines, Florida, 33744

  • Study site

    Boston, Massachusetts, 02114

  • Study site

    Boston, Massachusetts, 02115

  • Study site

    Bowling Green, Kentucky, 42101

  • Study site

    Brandon, Florida, 33511

  • Study site

    Brooksville, Florida, 34613

  • Study site

    Burbank, California, 91505

  • Study site

    Burlington, Vermont, 05403

  • Study site

    Butte, Montana, 59701

  • Study site

    Cedar Knolls, New Jersey, 07927

  • Study site

    Centerville, Ohio, 45459

  • Study site

    Charleston, South Carolina, 29401

  • Study site

    Chicago, Illinois, 60634

  • Study site

    Clive, Iowa, 50325

  • Study site

    Danville, Virginia, 24541

  • Study site

    Decatur, Illinois, 62526

  • Study site

    Denver, Colorado, 80204

  • Study site

    Denver, Colorado, 80210

  • Study site

    Denver, Colorado, 80218-1191

  • Study site

    Denver, Colorado, 80262

  • Study site

    Des Moines, Iowa, 50302

  • Study site

    Des Moines, Iowa, 50309

  • Study site

    Detroit, Michigan, 48201

  • Study site

    Detroit, Michigan, 48202

  • Study site

    Doylestown, Pennsylvania, 18901

  • Study site

    Dubuque, Iowa, 52002

  • Study site

    Eau Claire, Wisconsin, 54710

  • Study site

    Everton, Missouri, 65646

  • Study site

    Fargo, North Dakota, 58122

  • Study site

    Fort Eisenhower, Georgia, 30905

  • Study site

    Greenville, North Carolina, 27834

  • Study site

    Greenville, South Carolina, 29605

  • Study site

    Hagerstown, Maryland, 21740

  • Study site

    Hermitage, Tennessee, 37076

  • Study site

    Hines, Illinois, 60141

  • Study site

    Honolulu, Hawaii, 96813

  • Study site

    Houston, Texas, 77030

  • Study site

    Indianapolis, Indiana, 46202

  • Study site

    Iowa City, Iowa, 52242

  • Study site

    Jacksonville, Florida, 32207

  • Study site

    Kansas City, Missouri, 64111

  • Study site

    Lafayette, Indiana, 47904

  • Study site

    Lancaster, Pennsylvania, 17602

  • Study site

    Lebanon, New Hampshire, 03756

  • Study site

    Los Angeles, California, 90073

  • Study site

    Los Angeles, California, 90089

  • Study site

    Los Angeles, California, 90095

  • Study site

    Louisville, Kentucky, 40202

  • Study site

    Louisville, Kentucky, 40206-1499

  • Study site

    Marshfield, Wisconsin, 54449

  • Study site

    Maywood, Illinois, 60153

  • Study site

    Milwaukee, Wisconsin, 53226

  • Study site

    Missoula, Montana, 59802

  • Study site

    Modesto, California, 95350

  • Study site

    Muncie, Indiana, 47303

  • Study site

    Muskegon, Michigan, 49444

  • Study site

    Neptune City, New Jersey, 07753

  • Study site

    New Hyde Park, New York, 11040

  • Study site

    New Orleans, Louisiana, 70115

  • Study site

    New Orleans, Louisiana, 70121

  • Study site

    New York, New York, 10016

  • Study site

    Newark, Delaware, 19718

  • Study site

    Newark, New Jersey, 07103

  • Study site

    Newport Beach, California, 92663

  • Study site

    North Chicago, Illinois, 60064

  • Study site

    Ocean Springs, Mississippi, 39564

  • Study site

    Philadelphia, Pennsylvania, 19140

  • Study site

    Philadelphia, Pennsylvania, 19141

  • Study site

    Phoenix, Arizona, 85006

  • Study site

    Phoenix, Arizona, 85012

  • Study site

    Pittsburgh, Pennsylvania, 15212

  • Study site

    Pittsburgh, Pennsylvania, 15261

  • Study site

    Raleigh, North Carolina, 27612

  • Study site

    Rapid City, South Dakota, 57701

  • Study site

    Richmond, Virginia, 23249

  • Study site

    Richmond, Virginia, 23298

  • Study site

    Rochester, Minnesota, 55905

  • Study site

    Rogers, Arkansas, 72756

  • Study site

    Sacramento, California, 95817

  • Study site

    San Diego, California, 92103

  • Study site

    Savannah, Georgia, 31405

  • Study site

    St Louis, Missouri, 63110

  • Study site

    Syracuse, New York, 13210

  • Study site

    Tacoma, Washington, 98431

  • Study site

    Tampa, Florida, 33607

  • Study site

    Toledo, Ohio, 43608

  • Study site

    Trenton, New Jersey, 08629

  • Study site

    Tyler, Texas, 75702

  • Study site

    Winchester, Virginia, 22601

  • Study site

    Worcester, Massachusetts, 01608-1320

  • Study site

    Worcester, Massachusetts, 01655

  • Study site

    Zephyrhills, Florida, 33542

Other trials in United States

Canada40 sites

  • Study site

    Ajax, Ontario, L1S 2J5

  • Study site

    Calgary, Alberta, T2N 2T9

  • Study site

    Chicoutimi, Quebec, G7H 5H6

  • Study site

    Edmonton, Alberta, T5H 3V9

  • Study site

    Green Field Park, Quebec, J4V 2H1

  • Study site

    Guelph, Ontario, N1E 4J4

  • Study site

    Halifax, Nova Scotia, B3H 2Y9

  • Study site

    Hamilton, Ontario, L8N 4A6

  • Study site

    Kelowna, British Columbia, V1V 1Y5

  • Study site

    Kelowna, British Columbia, V1Y 1T2 & V1Y3G8

  • Study site

    Kingston, Ontario, K7L 3N6

  • Study site

    Lévis, Quebec, G6V 3Z1

  • Study site

    London, Ontario, N6A 4G5

  • Study site

    Moncton, New Brunswick, E1C 6Z8

  • Study site

    Montreal, Quebec, H1T 2M4

  • Study site

    Montreal, Quebec, H3A 1A1

  • Study site

    Montreal, Quebec, H3G 1A4

  • Study site

    Ottawa, Ontario, K1H 8L6

  • Study site

    Peterborough, Ontario, K9J 7B3

  • Study site

    Québec, Quebec, G1L 3L5

  • Study site

    Québec, Quebec, G1R 2J6

  • Study site

    Saint John, New Brunswick, E2K 4L2

  • Study site

    Saint-Charles-Borromée, Quebec, J6E 2C3

  • Study site

    Saint-Hyacinthe, Quebec, J2S 4Y8

  • Study site

    Sainte-Foy, Quebec, G1V 4G2

  • Study site

    Saskatoon, Saskatchewan, S7K 1J5

  • Study site

    Scarborough Village, Ontario, M1E 4B9

  • Study site

    Thunder Bay, Ontario, P7B 6V1

  • Study site

    Toronto, Ontario, M2K 1E1

  • Study site

    Toronto, Ontario, M3N 2V6

  • Study site

    Toronto, Ontario, M4N 3M5

  • Study site

    Toronto, Ontario, M5G 1X5

  • Study site

    Toronto, Ontario, M5G 2M9 & M5G 1X5

  • Study site

    Trois-Rivières, Quebec, G9A 1Y1

  • Study site

    Vancouver, British Columbia, V5Z 3J5

  • Study site

    Victoria, British Columbia, V8R 1J8

  • Study site

    Windsor, Ontario, N8X 3V6

  • Study site

    Windsor, Ontario, N9A 1E1

  • Study site

    Winnipeg, Manitoba, R3A 1R9

  • Study site

    Winnipeg, Manitoba, R3C 0N2

Other trials in Canada

Puerto Rico1 site

  • Study site

    San Juan, 00935

Other trials in Puerto Rico

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 the US and Canada. 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. Total length of participation is approximately 6 weeks.

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

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 posted28 Mar 2005 (estimated)
  2. Study startMar 2005
  3. Study completionFeb 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
IDs, dates and publications
ClinicalTrials.gov ID
NCT00106509
Sponsor's protocol ID
GD3-170-301
Status last verified
Mar 2015
First submitted
25 Mar 2005
Last updated
5 Mar 2015
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 Pseudomembranous Colitis, run by Genzyme, a Sanofi Company at 140 sites in 3 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 140 sites in United States, 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 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 NCT00106509, 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 5 Mar 2015.

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