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NCT02437487 · ClinicalTrials.gov registry record · Phase 2

SER-109 Versus Placebo to Prevent Recurrent Clostridium Difficile Infection (RCDI)

A Phase 2 study of Clostridium Difficile, sponsored by Seres Therapeutics.

Completed
Registry status
Phase 2
Development phase
89
Enrollment target
20
Study locations

NCT02437487: Completed Phase 2 study of Clostridium Difficile, sponsored by Seres Therapeutics.

NCT02437487 is a Phase 2 study of Clostridium Difficile that has completed, run by Seres Therapeutics. The registered enrollment target is 89 participants, below the 447-participant average among 6 other Clostridium Difficile trials with a reported enrollment target (80% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02437487, a Phase 2 study of Clostridium Difficile, has completed, sponsored by Seres Therapeutics.

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

Study Summary

The study will involve administering the study drug as a single dose of study drug or placebo. This study is designed to demonstrate the superiority of the experimental drug versus placebo in adult patients with recurrent CDI.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG SER-109

Study Locations (20)

Florida

  • ZASA Clinical Research - Atlantis
  • Omega Research Consultants LLC - DeBary
  • Borland-Groover Clinic - Jacksonville
  • Gastroenterology Group of Naples - Naples
  • Advanced Medical Research Center - Port Orange

California

  • North County Gastroenterology - Oceanside
  • University Of California Davis - Sacramento
  • Ventura Clinical Trials - Ventura

Maryland

  • Anne Arundel Health System Research Institute - Annapolis
  • Johns Hopkins Bayview Medical - Baltimore
  • Metropolitan Gastroenterolgy Group Pc - Chevy Chase

Massachusetts

  • Massachusetts General Hospital - Boston
  • Beth Israel Deaconess Med Cntr - Boston

Georgia

  • Emory University - Atlanta

Idaho

  • Idaho Falls Infection Diseases - Idaho Falls

Louisiana

  • Ochsner Clinic Foundation - New Orleans

Michigan

  • William Beaumont Hospital - Royal Oak

Trial Details

FieldValue
Enrollment Target 89 participants
Start Date 2015-05
Est. Completion 2016-10
Phase Phase 2
Seres Therapeutics

7 total trials

What the finished NCT02437487 record still lists

NCT02437487 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 89 participants, a relatively small participant target, below the 447-participant average among 6 other Clostridium Difficile trials with a reported enrollment target (80% lower).

The record links to 1 condition, with Clostridium Difficile appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT02437487 names 20 study sites across 11 states, led by Florida, California, Maryland.

Frequently Asked Questions

What is clinical trial NCT02437487 about?

NCT02437487 is a clinical study titled "SER-109 Versus Placebo to Prevent Recurrent Clostridium Difficile Infection (RCDI)". The study will involve administering the study drug as a single dose of study drug or placebo. This study is designed to demonstrate the superiority of the experimental drug versus placebo in adult patients with recurrent CDI.

What is the current status of trial NCT02437487?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 89 participants. The study started on 2015-05. Estimated completion is 2016-10.

What conditions does trial NCT02437487 study?

This clinical trial studies the following conditions: Clostridium Difficile.

What interventions are being tested in trial NCT02437487?

The interventions under investigation include: Placebo (DRUG), SER-109 (DRUG).

Who is sponsoring clinical trial NCT02437487?

This trial is sponsored by Seres Therapeutics, which has 7 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02437487 being conducted?

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

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Source: ClinicalTrials.gov NCT02437487, the US trial registry maintained by the National Library of Medicine. NCT02437487 (small enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.