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NCT01353079 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety Study Of Short Ragweed Pollen Sublingual-Oral Immunotherapy
A Phase 3 study, sponsored by Greer Laboratories.
- Completed
- Registry status
- Phase 3
- Development phase
- 429
- Enrollment target
NCT01353079: Completed Phase 3 study, sponsored by Greer Laboratories.
NCT01353079 is a Phase 3 study that has completed, run by Greer Laboratories. The registered enrollment target is 429 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (44% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01353079, a Phase 3 study, has completed, sponsored by Greer Laboratories.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 429 participants
- Enrollment target
Study Summary
The primary objective of this study is to demonstrate that SLIT administered pre-and co-seasonally is effective in reducing rhinoconjunctivitis symptoms during the entire short ragweed pollen season.
Primary Outcome
Change in baseline in avg combined daily RSS and medication scores during entire ragweed season in ITT population. Symptom score: sum of scores from 8 symptoms rated 0-3 (0=absent, 1=mild, 2=moderate, 3=severe), ocular (itchiness, swelling/redness, and watery eyes/tears), nasal (sneezing, itching, runny and stuffy nose), and ears (itching). Avg daily RSS computed by: (1) summing 8 individual allergy symptoms recorded in AM and PM; (2) forming daily RSS by summing AM and PM RSS for each day of ra
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL Short Ragweed Pollen Allergenic Extract
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 429 participants |
| Start Date | 2011-04 |
| Est. Completion | 2012-04 |
| Phase | Phase 3 |
What the finished NCT01353079 record still lists
NCT01353079 is an interventional study that assigns participants to a tested intervention. The registered 429 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (44% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01353079 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01353079 about?
NCT01353079 is a clinical study titled "Efficacy and Safety Study Of Short Ragweed Pollen Sublingual-Oral Immunotherapy". The primary objective of this study is to demonstrate that SLIT administered pre-and co-seasonally is effective in reducing rhinoconjunctivitis symptoms during the entire short ragweed pollen season.
What is the current status of trial NCT01353079?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 429 participants. The study started on 2011-04. Estimated completion is 2012-04.
What interventions are being tested in trial NCT01353079?
The interventions under investigation include: Placebo (BIOLOGICAL), Short Ragweed Pollen Allergenic Extract (BIOLOGICAL).
Who is sponsoring clinical trial NCT01353079?
This trial is sponsored by Greer Laboratories, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01353079's enrollment target sits among peer trials
429 878th of 2000 higher than 1,123 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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