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COMPLETED Phase 3

A Clinical Trial to Evaluate the Safety, Efficacy, and Immunogenicity of DR-5001

NCT00382408 · View on ClinicalTrials.gov ↗

Study Summary

This is a multicenter, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of oral DR-5001 in reducing the attack rate of febrile acute respiratory disease caused by type-4 and type-7 adenovirus as well as determine its immunogenicity.

Conditions Studied

Interventions

  • OTHER Placebo
  • BIOLOGICAL DR-5001

Study Locations (2)

Illinois

  • Duramed Investigational Site — Great Lakes

South Carolina

  • Duramed Investigational Site — Fort Jackson

Trial Details

FieldValue
Enrollment Target 4,040 participants
Start Date 2006-09
Est. Completion 2007-12
Phase Phase 3

Sponsor

Duramed Research

4 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00382408

The ClinicalTrials.gov registry entry for NCT00382408 describes a study currently listed as completed. It is categorized as Phase 3, 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 4,040 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duramed Research, which has 4 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 Respiratory Tract Diseases 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: NCT00382408 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Illinois, South Carolina. 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 NCT00382408 about?

NCT00382408 is a clinical study titled "A Clinical Trial to Evaluate the Safety, Efficacy, and Immunogenicity of DR-5001". This is a multicenter, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of oral DR-5001 in reducing the attack rate of febrile acute respiratory disease caused by type-4 and type-7 adenovirus as well as determine its immunogenicity.

What is the current status of trial NCT00382408?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 4,040 participants. The study started on 2006-09. Estimated completion is 2007-12.

What conditions does trial NCT00382408 study?

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

What interventions are being tested in trial NCT00382408?

The interventions under investigation include: Placebo (OTHER), DR-5001 (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00382408?

This trial is sponsored by Duramed Research, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00382408 being conducted?

This trial has 2 study locations across Illinois, South Carolina. 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