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NCT01566448 · ClinicalTrials.gov registry record · Phase 2
Treatment of Severe Mucositis Pain With Oral Ketamine Mouthwash
A Phase 2 study, sponsored by Aaron Cumpston, PharmD, BCOP.
- Completed
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
NCT01566448: Completed Phase 2 study, sponsored by Aaron Cumpston, PharmD, BCOP.
NCT01566448 is a Phase 2 study that has completed, run by Aaron Cumpston, PharmD, BCOP. The registered enrollment target is 30 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01566448, a Phase 2 study, has completed, sponsored by Aaron Cumpston, PharmD, BCOP.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
Study Summary
Oral mucositis (inflammation of the lining of the mouth) is a very common adverse effect when chemotherapy and radiation therapy are used to treat cancer. Mucositis occurs in about 40% of patients receiving standard dose chemotherapy, 80% of patients receiving radiation therapy of the head and neck, and up to 100% of patients undergoing a bone marrow transplant. Because the pain from mucositis can be so bad it can cause the inability to eat or drink, inability to talk, gagging and drooling. Many times mucositis can affect cancer treatment because patients may have to be given a lower dose of a drug or stop treatment completely. There are not many treatments today that can help relieve the severe pain caused from mucositis. This research study will help researchers determine if using an oral mouthwash called Ketamine will help lessen mucositis pain. Ketamine is approved by the Food and Drug Administration (FDA) for use with general anesthesia, sedation and for severe pain. WVU Hospital is now using Ketamine mouthwash as a standard treatment option for mucositis pain. During this study patients will be assessed to determine the level of pain caused by their mucositis. This will occur before the first dose, one hour after the first dose, and then daily until they are no longer on the study. Patients will use the mouthwash by swishing and spitting (20mg/5ml) four times each day, and also every four hours as needed. Patients will use the mouthwash on this study until their mucositis gets better or until the mucositis gets worse (or if the pain does not get better after three days of treatment).
Primary Outcome
Change in pain score as reported at baseline and after the use of ketamine mouthwash on a numeric scale from 0 to 10, with 0 representing no pain and 10 representing the worst pain.
Interventions
- DRUG Ketamine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2012-02 |
| Est. Completion | 2015-07 |
| Phase | Phase 2 |
What the finished NCT01566448 record still lists
NCT01566448 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 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 1 intervention - of which Ketamine is the first listed.
NCT01566448 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01566448 about?
NCT01566448 is a clinical study titled "Treatment of Severe Mucositis Pain With Oral Ketamine Mouthwash". Oral mucositis (inflammation of the lining of the mouth) is a very common adverse effect when chemotherapy and radiation therapy are used to treat cancer. Mucositis occurs in about 40% of patients receiving standard dose chemotherapy, 80% of patients receiving radiation therapy of the head and neck,...
What is the current status of trial NCT01566448?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2012-02. Estimated completion is 2015-07.
What interventions are being tested in trial NCT01566448?
The interventions under investigation include: Ketamine (DRUG).
Who is sponsoring clinical trial NCT01566448?
This trial is sponsored by Aaron Cumpston, PharmD, BCOP, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01566448's enrollment target sits among peer trials
30 1582nd of 2000 higher than 332 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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