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COMPLETED Phase 4

Evaluate the Potential of Montelukast to Prevent Nasal Symptomatology During Colds

NCT00189475 · View on ClinicalTrials.gov ↗

Study Summary

Assesses the efficacy of treatment with montelukast 10 mg PO QD x 5 days versus placebo for the treatment of viral-induced upper respiratory infection in healthy adults aged 18-50 years.

Interventions

  • DRUG Placebo
  • DRUG Montelukast

Study Locations (1)

Pennsylvania

  • Allegheny General Hospital — Pittsburgh

Trial Details

FieldValue
Enrollment Target 84 participants
Start Date 2003-10
Est. Completion 2007-07
Phase Phase 4

Sponsor

Deborah Gentile

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00189475

The ClinicalTrials.gov registry entry for NCT00189475 describes a study currently listed as completed. It is categorized as Phase 4, 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 84 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Deborah Gentile, which has 3 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 Upper Respiratory Infection appearing as the primary indexed condition, and to 2 interventions — of which Placebo 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: NCT00189475 reports 1 study location spanning 1 distinct geographic area — top geographies include Pennsylvania. 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 NCT00189475 about?

NCT00189475 is a clinical study titled "Evaluate the Potential of Montelukast to Prevent Nasal Symptomatology During Colds". Assesses the efficacy of treatment with montelukast 10 mg PO QD x 5 days versus placebo for the treatment of viral-induced upper respiratory infection in healthy adults aged 18-50 years.

What is the current status of trial NCT00189475?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 84 participants. The study started on 2003-10. Estimated completion is 2007-07.

What conditions does trial NCT00189475 study?

This clinical trial studies the following conditions: Upper Respiratory Infection. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00189475?

The interventions under investigation include: Placebo (DRUG), Montelukast (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00189475?

This trial is sponsored by Deborah Gentile, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00189475 being conducted?

This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

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