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NCT00382408 · ClinicalTrials.gov registry record · Phase 3
A Clinical Trial to Evaluate the Safety, Efficacy, and Immunogenicity of DR-5001
A Phase 3 study of Respiratory Tract Diseases, sponsored by Duramed Research.
- Completed
- Registry status
- Phase 3
- Development phase
- 4,040
- Enrollment target
- 2
- Study locations
NCT00382408: Completed Phase 3 study of Respiratory Tract Diseases, sponsored by Duramed Research.
NCT00382408 is a Phase 3 study of Respiratory Tract Diseases that has completed, run by Duramed Research. The registered enrollment target is 4,040 participants, above the 1,768-participant average among 8 other Respiratory Tract Diseases trials with a reported enrollment target (129% higher). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00382408, a Phase 3 study of Respiratory Tract Diseases, has completed, sponsored by Duramed Research.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 4,040 participants
- Enrollment target
- 2
- Study locations
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.
Primary Outcome
For the oral Type-4 vaccine, the primary outcome is the number of cases of ADV-4 febrile acute respiratory disease (ARD), defined as a subject with one or more clinical signs and symptoms of ARD and an oral temperature ≥ 100.5°F (38.06°C) and throat culture positive for wild ADV Type-4 infection. This outcome used the intent-to-treat cohort.
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
| Field | Value |
|---|---|
| Enrollment Target | 4,040 participants |
| Start Date | 2006-09 |
| Est. Completion | 2007-12 |
| Phase | Phase 3 |
What the finished NCT00382408 record still lists
NCT00382408 is an interventional study that assigns participants to a tested intervention. Its 4,040 participants enrollment target places it among the larger protocols in the corpus, above the 1,768-participant average among 8 other Respiratory Tract Diseases trials with a reported enrollment target (129% higher).
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.
NCT00382408 reports a single indexed study location in Illinois, South Carolina.
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.
What interventions are being tested in trial NCT00382408?
The interventions under investigation include: Placebo (OTHER), DR-5001 (BIOLOGICAL).
Who is sponsoring clinical trial NCT00382408?
This trial is sponsored by Duramed Research, which has 23 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT00382408's enrollment target sits among peer trials
4,040 2nd of 8 the highest of 8 other Respiratory Tract Diseases trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Respiratory Tract Diseases 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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