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NCT01385748 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety Study of Clonidine Lauriad® to Treat Oral Mucositis
A Phase 2 study, sponsored by Valerio Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 183
- Enrollment target
NCT01385748: Completed Phase 2 study, sponsored by Valerio Therapeutics.
NCT01385748 is a Phase 2 study that has completed, run by Valerio Therapeutics. The registered enrollment target is 183 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (38% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01385748, a Phase 2 study, has completed, sponsored by Valerio Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 183 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy and safety of Clonidine Lauriad® to treat chemoradiation therapy induced severe oral mucositis in patients with head and neck cancer.
Primary Outcome
The primary endpoint planned in the protocol was the percentage of participants with an oral mucositis score greater than or equal to 3 using the WHO oral mucositis severity scale at a cumulative radiation dose of 50 Gy. This was modified by protocol amendment to the cumulative radiation dose at which a WHO score greater than or equal to 3 was first observed. This change was made to account for the fact that in real practice most patients receive a cumulative dose between 60 and 70 Gy. The prese
Interventions
- DRUG Clonidine Lauriad® 50µg
- DRUG Clonidine Lauriad® 100µg
- DRUG Placebo Lauriad®
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 183 participants |
| Start Date | 2010-04 |
| Est. Completion | 2014-12 |
| Phase | Phase 2 |
What the finished NCT01385748 record still lists
NCT01385748 is an interventional study that assigns participants to a tested intervention. The registered 183 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (38% higher).
The record links to 0 conditions, and to 3 interventions - of which Clonidine Lauriad® 50µg is the first listed.
NCT01385748 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01385748 about?
NCT01385748 is a clinical study titled "Efficacy and Safety Study of Clonidine Lauriad® to Treat Oral Mucositis". The purpose of this study is to evaluate the efficacy and safety of Clonidine Lauriad® to treat chemoradiation therapy induced severe oral mucositis in patients with head and neck cancer.
What is the current status of trial NCT01385748?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 183 participants. The study started on 2010-04. Estimated completion is 2014-12.
What interventions are being tested in trial NCT01385748?
The interventions under investigation include: Clonidine Lauriad® 50µg (DRUG), Clonidine Lauriad® 100µg (DRUG), Placebo Lauriad® (DRUG).
Who is sponsoring clinical trial NCT01385748?
This trial is sponsored by Valerio Therapeutics, which has 13 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01385748's enrollment target sits among peer trials
183 363rd of 2000 higher than 1,638 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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