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TerminatedNCT00466635Updated Mar 19, 2015

A Study to Assess the Safety, Tolerability, Effectiveness and Absorption of Exodif™ Tablets in Clostridium Difficile-associated Diarrhea

A Phase 3 interventional study of GT267-004 (tolevamer potassium sodium) in Enterocolitis, Pseudomembranous, Diarrhea and Clostridium Difficile, sponsored by Genzyme, a Sanofi Company. Terminated at 13 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-03-19.

Sponsored by Genzyme, a Sanofi Company · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
65
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Enterocolitis, Pseudomembranous
  • Diarrhea
  • Clostridium Difficile

Keywords

  • Clostridium difficile Disease
  • Infectious diarrhea
  • C. difficile
  • CDAD
  • Clostridium difficile-associated diarrhea
  • Clostridium difficile diarrhea
  • Antibiotic-Associated Colitis
  • Clostridium Enterocolitis
  • Antibiotic-Associated Diarrhea
  • Pseudomembranous Colitis
  • Clostridium difficile
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Any contraindication to oral / enteral therapy including fulminant C. difficile disease.
  • Any acutely life-threatening medical conditions.
  • Acute or chronic diarrhea of other cause.
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
65 participants (estimated)

Interventions

  • DrugGT267-004 (tolevamer potassium sodium)
05

What researchers measure

Primary outcomes

  1. Clinical Success

  2. Safety

Secondary outcomes

  1. The extent of tolevamer absorption

06

Study locations

13 sites
  • Modesto, California, United States
  • Honolulu, Hawaii, United States
  • Maywood, Illinois, United States
  • Baltimore, Maryland, United States
  • Worcester, Massachusetts, United States
  • West Bloomfield, Michigan, United States
  • Butte, Montana, United States
  • Cedar Knolls, New Jersey, United States
  • Neptune, New Jersey, United States
  • Syracuse, New York, United States
  • Greenville, North Carolina, United States
  • Toledo, Ohio, United States
  • Lancaster, Pennsylvania, United States
07

Registry details

Key details

Study ID
NCT00466635
Lead sponsor
Genzyme, a Sanofi Company
First posted
Apr 27, 2007
Start date
Apr 2007
Completion
Aug 2007
Last update
Mar 19, 2015

Study contacts

Medical Monitor
study director · Genzyme, a Sanofi Company
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

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