OPT-80 in Clostridium Difficile-Associated Diarrhea (CDAD)

An Open-Label, Dose Ranging, Randomized Clinical Evaluation of OPT-80 in Patients With Clostridium Difficile-Associated Diarrhea (CDAD)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00097422

Enrollment

Unknown

Registered

2004-11-24

Start date

2004-11-01

Completion date

2005-04-01

Last updated

2017-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diarrhea

Keywords

CDAD, diarrhea, Clostridium difficile-Associated Diarrhea

Brief summary

The purpose of this study is to investigate the safety and perform preliminary clinical evaluation in patients with mild to moderate CDAD.

Detailed description

This is a dose-finding study to select a safe and efficacious dose of OPT-80. Patients will be evaluated for safety and efficacy and pharmacokinetic parameters will be investigated.

Interventions

DRUGOPT-80

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients with CDAD

Exclusion criteria

* Patients with severe CDAD

Design outcomes

Primary

Measure	Time frame
Relief of symptoms of CDAD	—

Secondary

Measure	Time frame
Recurrence Rate.	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026