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NCT01222702 · ClinicalTrials.gov registry record · Phase 2

Efficacy, Safety and Tolerability of Cadazolid in Subjects With Clostridium Difficile Associated Diarrhea (CDAD)

A Phase 2 study of Clostridium Difficile Infection, sponsored by Actelion.

Completed
Registry status
Phase 2
Development phase
84
Enrollment target
20
Study locations

NCT01222702 is a Phase 2 study of Clostridium Difficile Infection that has completed, run by Actelion. The registered enrollment target is 84 participants, below the 12,059-participant average among 13 other Clostridium Difficile Infection trials with a reported enrollment target (99% lower). The trial reports 20 study locations across 12 states.

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The verdict

NCT01222702, a Phase 2 study of Clostridium Difficile Infection, has completed, sponsored by Actelion.

COMPLETED
Registry status
Phase 2
Development phase
84 participants
Enrollment target
20
Study locations

Study Summary

Cadazolid is a new antibiotic developed for the treatment of Clostridiun difficile associated diarrhea (CDAD), also known as Clostridium Difficile Infection (CDI). The purpose of the study was to evaluate the efficacy and safety of different doses of cadazolid in order to find the dose of cadazolid to be used for further clinical development of the compound in subjects with CDAD.

Conditions Studied

Clostridium Difficile Infection

Interventions

  • DRUG Vancomycin
  • DRUG Cadazolid
  • DRUG Placebo-matching cadazolid
  • DRUG Placebo-matching vancomycin

Study Locations (20)

Other

  • Clinical Ivestigative Site 6602 - Calgary
  • Clinical Investigative Site 6632 - Cologne
  • Clinical Investigative Site 6633 - Regensburg
  • Clinical Investigative Site 6634 - Ulm
  • Clinical Investigative Site 6734 - Busto Arsizio
  • Clinical Investigative Site 6735 - Modena

Florida

  • Clinical Investigative Site 6919 - Jacksonville
  • Clinical Investigative Site 6938 - Orlando

Georgia

  • Clinical Investigative Site 6930 - Decatur
  • Clinical Investigative Site 6935 - Marietta

Quebec

  • Clinical Investigative Site 6601 - Montreal
  • Clinical Investigative Site 6606 - Sherbrooke

Delaware

  • Clinical Investigative Site 6902 - Newark

Idaho

  • Clinical Investigative Site 6915 - Idaho Falls

Illinois

  • Clinical Investigative Site 6906 - Chicago

Massachusetts

  • Clinical Investigative Site 6917 - Boston

Trial Details

FieldValue
Enrollment Target 84 participants
Start Date 2011-01-25
Est. Completion 2012-11-12
Phase Phase 2

Sponsor

Actelion

63 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01222702

The ClinicalTrials.gov registry entry for NCT01222702 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 84 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 12,059-participant average among 13 other Clostridium Difficile Infection trials with a reported enrollment target (99% lower). The listed sponsor is Actelion, which has 63 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Clostridium Difficile Infection appearing as the primary indexed condition, and to 4 interventions - of which Vancomycin is the first listed.

NCT01222702 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Other, Florida, Georgia.

Frequently Asked Questions

What is clinical trial NCT01222702 about?

NCT01222702 is a clinical study titled "Efficacy, Safety and Tolerability of Cadazolid in Subjects With Clostridium Difficile Associated Diarrhea (CDAD)". Cadazolid is a new antibiotic developed for the treatment of Clostridiun difficile associated diarrhea (CDAD), also known as Clostridium Difficile Infection (CDI). The purpose of the study was to evaluate the efficacy and safety of different doses of cadazolid in order to find the dose of cadazolid ...

What is the current status of trial NCT01222702?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 84 participants. The study started on 2011-01-25. Estimated completion is 2012-11-12.

What conditions does trial NCT01222702 study?

This clinical trial studies the following conditions: Clostridium Difficile Infection.

What interventions are being tested in trial NCT01222702?

The interventions under investigation include: Vancomycin (DRUG), Cadazolid (DRUG), Placebo-matching cadazolid (DRUG), Placebo-matching vancomycin (DRUG).

Who is sponsoring clinical trial NCT01222702?

This trial is sponsored by Actelion, which has 63 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01222702 being conducted?

This trial has 20 study locations across Delaware, Florida, Georgia, Idaho, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.