NCT00466635

Brief 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). All study related care is provided including doctor visits, physical exams, laboratory tests and study medication. Total length of participation is 6 weeks.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2007

Shorter than P25 for phase_3

Geographic Reach
1 country

13 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

April 25, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 27, 2007

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

March 19, 2015

Status Verified

March 1, 2015

First QC Date

April 25, 2007

Last Update Submit

March 17, 2015

Conditions

Enterocolitis, PseudomembranousDiarrheaClostridium Difficile

Keywords

Clostridium difficile DiseaseInfectious diarrheaC. difficileCDADClostridium difficile-associated diarrheaClostridium difficile diarrheaAntibiotic-Associated ColitisClostridium EnterocolitisAntibiotic-Associated DiarrheaPseudomembranous ColitisClostridium difficile

Outcome Measures

Primary Outcomes (2)

  • Clinical Success

  • Safety

Secondary Outcomes (1)

  • The extent of tolevamer absorption

Interventions

GT267-004 (tolevamer potassium sodium)DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The presence of CDAD at the time of enrollment
  • Negative serum pregnancy test (HCG) for women of childbearing potential.

You may not qualify if:

  • Any contraindication to oral / enteral therapy including fulminant C. difficile disease.
  • Any acutely life-threatening medical conditions.
  • Acute or chronic diarrhea of other cause.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Unknown Facility

Modesto, California, United States

Location

Unknown Facility

Honolulu, Hawaii, United States

Location

Unknown Facility

Maywood, Illinois, United States

Location

Unknown Facility

Baltimore, Maryland, United States

Location

Unknown Facility

Worcester, Massachusetts, United States

Location

Unknown Facility

West Bloomfield, Michigan, United States

Location

Unknown Facility

Butte, Montana, United States

Location

Unknown Facility

Cedar Knolls, New Jersey, United States

Location

Unknown Facility

Neptune City, New Jersey, United States

Location

Unknown Facility

Syracuse, New York, United States

Location

Unknown Facility

Greenville, North Carolina, United States

Location

Unknown Facility

Toledo, Ohio, United States

Location

Unknown Facility

Lancaster, Pennsylvania, United States

Location

MeSH Terms

Conditions

Enterocolitis, PseudomembranousDiarrheaDysentery

Condition Hierarchy (Ancestors)

Clostridium InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsEnterocolitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Medical Monitor

    Genzyme, a Sanofi Company

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 25, 2007

First Posted

April 27, 2007

Study Start

April 1, 2007

Study Completion

August 1, 2007

Last Updated

March 19, 2015

Record last verified: 2015-03

Locations

US(13)