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Safety Study of Inhaled 552-02 in Cystic Fibrosis Patients
NCT00274313 · View on ClinicalTrials.gov ↗
Study Summary
The purpose of this study is to evaluate the safety and tolerability of a new inhaled sodium-channel blocker called 552-02 in teens and adults with cystic fibrosis. 552-02 will be inhaled once a day for 14 days using a nebulizer. A small subgroup of patients will donate blood samples for pharmacokinetic analysis to see how 552-02 is absorbed into the blood and eliminated after 14 days of treatment.
Conditions Studied
Interventions
- DRUG 552-02
Study Locations (15)
Pennsylvania
- Hershey Medical Center — Hershey
- Children's Hospital of Philadelphia — Philadelphia
- University of Pittsburgh — Pittsburgh
California
- University of California at San Diego — San Diego
- University of California at San Francisco Medical Center — San Francisco
Florida
- Nemours Children's Clinic — Orlando
- University of South Florida — Tampa
Colorado
- The Children's Hospital — Denver
Illinois
- Children's Memorial Hospital — Chicago
Nebraska
- University of Nebraska Medical Center — Omaha
New Jersey
- Morristown Memorial Hospital — Morristown
New York
- State University of New York Upstate — Syracuse
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2006-01 |
| Est. Completion | 2006-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00274313
The ClinicalTrials.gov registry entry for NCT00274313 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Parion Sciences, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Cystic Fibrosis appearing as the primary indexed condition, and to 1 intervention — of which 552-02 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00274313 reports 15 study locations spanning 11 distinct geographic areas — top geographies include Pennsylvania, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00274313 about?
NCT00274313 is a clinical study titled "Safety Study of Inhaled 552-02 in Cystic Fibrosis Patients". The purpose of this study is to evaluate the safety and tolerability of a new inhaled sodium-channel blocker called 552-02 in teens and adults with cystic fibrosis. 552-02 will be inhaled once a day for 14 days using a nebulizer. A small subgroup of patients will donate blood samples for pharmacokin...
What is the current status of trial NCT00274313?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2006-01. Estimated completion is 2006-08.
What conditions does trial NCT00274313 study?
This clinical trial studies the following conditions: Cystic Fibrosis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00274313?
The interventions under investigation include: 552-02 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00274313?
This trial is sponsored by Parion Sciences, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00274313 being conducted?
This trial has 15 study locations across California, Colorado, Florida, Illinois, Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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