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NCT01066104 · ClinicalTrials.gov registry record · Phase 2
Subcutaneous Omalizumab for Treatment of Chronic Rhinosinusitis With Nasal Polyposis
A Phase 2 study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 2
- Development phase
- 27
- Enrollment target
NCT01066104: Completed Phase 2 study, sponsored by Massachusetts General Hospital.
NCT01066104 is a Phase 2 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 27 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01066104, a Phase 2 study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 27 participants
- Enrollment target
Study Summary
The investigators are doing this research study to learn more about a drug called Xolair (omalizumab). The investigators want to see if it is an effective treatment for chronic rhinosinusitis (CRS). Specifically, the investigators want to see whether Xolair will make nasal polyps smaller and less thick, and relieve symptoms in people with CRS. Polyps are abnormal growths of tissue that can grow in the lining of your sinuses (the inside of your nose). The investigators also want to find out if it is safe to use (whether it causes side effects).
Primary Outcome
Improvement is defined as any decrease in sinus CT scores at end of study. Quantification of polypoid mucosal thickening in the anterior ethmoid and maxillary sinuses on sinus CT scan (primary outcome variable): A sinus CT scan will be performed on Day 0 and repeated on Day 112. The CT scans will be performed with consistent orientation of the patient's head and landmarks to assure that both the pretreatment and posttreatment scans are done with identical orientation and sections. The CT scans
Interventions
- DRUG Xolair placebo
- DRUG Xolair (omalizumab)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2009-12 |
| Est. Completion | 2015-07 |
| Phase | Phase 2 |
What the finished NCT01066104 record still lists
NCT01066104 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 2 interventions - of which Xolair placebo is the first listed.
NCT01066104 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01066104 about?
NCT01066104 is a clinical study titled "Subcutaneous Omalizumab for Treatment of Chronic Rhinosinusitis With Nasal Polyposis". The investigators are doing this research study to learn more about a drug called Xolair (omalizumab). The investigators want to see if it is an effective treatment for chronic rhinosinusitis (CRS). Specifically, the investigators want to see whether Xolair will make nasal polyps smaller and less th...
What is the current status of trial NCT01066104?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 27 participants. The study started on 2009-12. Estimated completion is 2015-07.
What interventions are being tested in trial NCT01066104?
The interventions under investigation include: Xolair placebo (DRUG), Xolair (omalizumab) (DRUG).
Who is sponsoring clinical trial NCT01066104?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01066104's enrollment target sits among peer trials
27 1697th of 2000 higher than 293 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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