NCT00382304

Brief 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). 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2006

Shorter than P25 for phase_2

Geographic Reach
1 country

8 active sites

Status
completed

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

September 1, 2006

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

September 27, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 29, 2006

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

March 19, 2015

Status Verified

March 1, 2015

First QC Date

September 27, 2006

Last Update Submit

March 17, 2015

Conditions

Pseudomembranous ColitisClostridium Difficile DiarrheaAntibiotic-Associated Diarrhea

Keywords

Clostridium difficile-associated diarrheaC. difficileCDADClostridium difficileClostridium difficile DiseaseClostridium EnterocolitisAntibiotic-Associated ColitisInfectious diarrhea

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

tolevamer potassium-sodium (GT267-004)DRUG

Eligibility Criteria

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

You may qualify if:

  • years of age or older
  • The presence of CDAD at the time of enrollment with no other likely etiology for the diarrhea

You may not qualify if:

  • \> 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Unknown Facility

Edmonton, Alberta, T6G 2B7, Canada

Location

Unknown Facility

Nanaimo, British Columbia, V9S 2B7, Canada

Location

Unknown Facility

Vancouver, British Columbia, V3Z 1M9, Canada

Location

Unknown Facility

Ottowa, Ontario, K1H 8L6, Canada

Location

Unknown Facility

Richmond Hill, Ontario, L4C 4Z3, Canada

Location

Unknown Facility

Montreal, Quebec, H3T 1E2, Canada

Location

Unknown Facility

Rimouski, Quebec, G5L 5T1, Canada

Location

Unknown Facility

Sherbrooke, Quebec, J1H 5N4, Canada

Location

MeSH Terms

Conditions

Enterocolitis, PseudomembranousDysentery

Condition Hierarchy (Ancestors)

Clostridium InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsEnterocolitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Medical Monitor

    Genzyme, a Sanofi Company

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 27, 2006

First Posted

September 29, 2006

Study Start

September 1, 2006

Study Completion

September 1, 2007

Last Updated

March 19, 2015

Record last verified: 2015-03

Locations

CA(8)