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NCT05335148 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate the Safety of Colchicine
A Phase 1 study, sponsored by Rutgers, The State University of New Jersey.
- Active
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT05335148: Active Phase 1 study, sponsored by Rutgers, The State University of New Jersey.
NCT05335148 is a Phase 1 study that is active but no longer recruiting, run by Rutgers, The State University of New Jersey. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05335148, a Phase 1 study, is active but no longer recruiting, sponsored by Rutgers, The State University of New Jersey.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
Currently, there are no approved medications for the prevention and treatment of radiation-induced dermatitis, or skin discoloration/burning due to radiation therapy, because there is little evidence to guide treatment. The purpose of the research is to better understand the factors associated with radiation-induced dermatitis and to explore the efficacy of low-dose colchicine in reducing the proportion of patients with radiation-induced dermatitis who undergo radiation treatment for head and neck cancer. If you take part in the research, you will be asked to take 0.6 mg once a day by mouth. The participants time in the study will take less than a minute a day to take the pill and 20 minutes to complete survey questions during follow-up visits.
Primary Outcome
Pain (within radiation fields): assessed before radiotherapy, weekly during radiotherapy, and at the end of treatment with the visual analogue scale (VAS) (from 0 = no pain to 100 = maximum pain)
Interventions
- DRUG oral colchicine(0.6 mg) once a day
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2022-05-10 |
| Est. Completion | 2027-06-01 |
| Phase | Phase 1 |
What the registry record for NCT05335148 still lists
NCT05335148 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 1 intervention - of which oral colchicine(0.6 mg) once a day is the first listed.
NCT05335148 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05335148 about?
NCT05335148 is a clinical study titled "Study to Evaluate the Safety of Colchicine". Currently, there are no approved medications for the prevention and treatment of radiation-induced dermatitis, or skin discoloration/burning due to radiation therapy, because there is little evidence to guide treatment. The purpose of the research is to better understand the factors associated with...
What is the current status of trial NCT05335148?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2022-05-10. Estimated completion is 2027-06-01.
What interventions are being tested in trial NCT05335148?
The interventions under investigation include: oral colchicine(0.6 mg) once a day (DRUG).
Who is sponsoring clinical trial NCT05335148?
This trial is sponsored by Rutgers, The State University of New Jersey, which has 413 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05335148's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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