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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: Completed Phase 2 study of Cystic Fibrosis (CF), sponsored by Amgen.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Patients were required to cough deeply and then spit sputum into a sterile container. The bacteria contained in the sputum sample was incubated in a laboratory and the number of P. aeruginosa colony forming units per gram of sputum (CFU/g) was determined. The difference in CFUs/g were then compared from baseline to the conclusion of the 28 day treatment period
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 151 participants |
| Start Date | 2008-06 |
| Est. Completion | 2009-06 |
| Phase | Phase 2 |
What the finished NCT00677365 record still lists
NCT00677365 is an interventional study that assigns participants to a tested intervention. The registered 151 participants enrollment target is mid-sized for trials with a published cap, above the 130-participant average among 14 other Cystic Fibrosis (CF) trials with a reported enrollment target (16% higher).
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 names 20 study sites across 10 states, led by 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.
Learn More About Clinical Trials
Similar trials for Cystic Fibrosis (CF)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00677365's enrollment target sits among peer trials
151 5th of 14 higher than 10 of 14 other Cystic Fibrosis (CF) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cystic Fibrosis (CF) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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