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NCT00677365 · ClinicalTrials.gov registry record · Phase 2

Safety, Tolerability and Efficacy of MP-376 Given for 28 Days to Cystic Fibrosis (CF) Patients

A Phase 2 study of Cystic Fibrosis (CF), sponsored by Amgen.

Completed
Registry status
Phase 2
Development phase
151
Enrollment target
20
Study locations

NCT00677365 is a Phase 2 study of Cystic Fibrosis (CF) that has completed, run by Amgen. The registered enrollment target is 151 participants, above the 130-participant average among 14 other Cystic Fibrosis (CF) trials with a reported enrollment target (16% higher). The trial reports 20 study locations across 10 states.

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The verdict

NCT00677365, a Phase 2 study of Cystic Fibrosis (CF), has completed, sponsored by Amgen.

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

Study Summary

Patients with cystic fibrosis (CF) suffer from chronic infections of the lower respiratory tract that can be caused by one or multiple bacteria, including Pseudomonas aeruginosa, which has been particularly problematic to eradicate and been implicated as the major cause of morbidity and mortality in CF patients. Aerosol delivery of antibiotics directly to the lung increases the local concentrations of antibiotic at the site of infection resulting in improved antimicrobial effects compared to systemic administration. Bacterial resistance to current aerosol antibiotic treatments indicate a need for improved therapies to treat CF patients with pulmonary infections caused by multi-drug resistant Pseudomonas aeruginosa and other bacteria. High concentrations of MP-376 delivered directly to the lung are projected to have antimicrobial effects on even the most resistant organisms.

Conditions Studied

Cystic Fibrosis (CF)

Interventions

  • DRUG Placebo
  • DRUG MP-376

Study Locations (20)

California

  • Childrens Hospital - Los Angeles
  • - Los Angeles
  • - Oakland
  • - Orange
  • - Palo Alto
  • - Sacramento
  • - San Diego

Illinois

  • - Chicago
  • - Oak Lawn
  • - Park Ridge

Arizona

  • - Phoenix
  • - Tucson

Florida

  • - Miami
  • - Orlando

Alabama

  • - Mobile

Arkansas

  • - Little Rock

Iowa

  • - Iowa City

Kentucky

  • - Louisville

Trial Details

FieldValue
Enrollment Target 151 participants
Start Date 2008-06
Est. Completion 2009-06
Phase Phase 2

Sponsor

Amgen

558 total trials

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What the Registry Record Tells You About NCT00677365

The ClinicalTrials.gov registry entry for NCT00677365 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 151 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 130-participant average among 14 other Cystic Fibrosis (CF) trials with a reported enrollment target (16% higher). The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Cystic Fibrosis (CF) appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT00677365 reports 20 study locations spanning 10 distinct geographic areas - top geographies include California, Illinois, Arizona.

Frequently Asked Questions

What is clinical trial NCT00677365 about?

NCT00677365 is a clinical study titled "Safety, Tolerability and Efficacy of MP-376 Given for 28 Days to Cystic Fibrosis (CF) Patients". Patients with cystic fibrosis (CF) suffer from chronic infections of the lower respiratory tract that can be caused by one or multiple bacteria, including Pseudomonas aeruginosa, which has been particularly problematic to eradicate and been implicated as the major cause of morbidity and mortality in...

What is the current status of trial NCT00677365?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 151 participants. The study started on 2008-06. Estimated completion is 2009-06.

What conditions does trial NCT00677365 study?

This clinical trial studies the following conditions: Cystic Fibrosis (CF).

What interventions are being tested in trial NCT00677365?

The interventions under investigation include: Placebo (DRUG), MP-376 (DRUG).

Who is sponsoring clinical trial NCT00677365?

This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00677365 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.