NCT00097422

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Nov 2004

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

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

November 1, 2004

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

November 23, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 24, 2004

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
Last Updated

March 27, 2017

Status Verified

March 1, 2017

Enrollment Period

5 months

First QC Date

November 23, 2004

Last Update Submit

March 23, 2017

Conditions

Diarrhea

Keywords

CDAD, diarrheaClostridium difficile-Associated Diarrhea

Outcome Measures

Primary Outcomes (1)

  • Relief of symptoms of CDAD

Secondary Outcomes (1)

  • Recurrence Rate.

Interventions

OPT-80DRUG

Eligibility Criteria

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

You may qualify if:

  • Patients with CDAD

You may not qualify if:

  • Patients with severe CDAD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Advanced Biologics

New Hope, Pennsylvania, 18938, United States

Location

Related Publications (1)

  • Louie T, Miller M, Donskey C, Mullane K, Goldstein EJ. Clinical outcomes, safety, and pharmacokinetics of OPT-80 in a phase 2 trial with patients with Clostridium difficile infection. Antimicrob Agents Chemother. 2009 Jan;53(1):223-8. doi: 10.1128/AAC.01442-07. Epub 2008 Oct 27.

    PMID: 18955525RESULT

MeSH Terms

Conditions

Diarrhea

Interventions

OPT 80

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2004

First Posted

November 24, 2004

Study Start

November 1, 2004

Primary Completion

April 1, 2005

Study Completion

April 1, 2005

Last Updated

March 27, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will share

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\_Updated%20July\_9\_2014.pdf http://engagezone.msd.com/ds\_documentation.php

Locations

US(1)