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Completed

NCT Number: NCT00097422

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

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

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Key information

Conditions

Diarrhea Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Advanced Biologics

New Hope, Pennsylvania, 18938, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with CDAD

Exclusion criteria

  • Patients with severe CDAD

Treatment and study plan

OPT-80

Drug

Primary outcomes

  1. Relief of symptoms of CDAD

Secondary outcomes

  1. Recurrence Rate.

Sponsors and collaborators

Lead sponsor

Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Industry

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Nov 24, 2004
Registry last updated
Mar 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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