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NCT01653327 · ClinicalTrials.gov registry record · Phase 2
Analgesic Effects of Topical Ketamine Mouthwash in Patients Receiving Chemoradiation or Radiotherapy for Head & Neck Cancer
A Phase 2 study, sponsored by Dartmouth-Hitchcock Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 11
- Enrollment target
NCT01653327: Completed Phase 2 study, sponsored by Dartmouth-Hitchcock Medical Center.
NCT01653327 is a Phase 2 study that has completed, run by Dartmouth-Hitchcock Medical Center. The registered enrollment target is 11 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01653327, a Phase 2 study, has completed, sponsored by Dartmouth-Hitchcock Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 11 participants
- Enrollment target
Study Summary
* The primary objective is to determine the reduction in pain score by ketamine mouthwash compared to placebo in head and neck cancer patients with refractory mucositis. * The secondary objectives are to describe the duration of analgesia and adverse effects associated with ketamine and placebo.
Primary Outcome
The primary analysis is testing and estimating the effect of ketamine in comparison to placebo. Pain assessment will be analyzed using descriptive statistics. We will determine average pain scores. Pain will be measured using a 0-10 scale with 0 representing no pain; 1-3 representing mild pain; 4-6 representing moderate pain; and 7-10 representing severe pain. The effect of ketamine in comparison to placebo will be estimated with a mean and confidence interval. Proportional changes in pain score
Interventions
- DRUG Placebo
- DRUG Ketamine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2010-06 |
| Est. Completion | 2016-08-16 |
| Phase | Phase 2 |
What the finished NCT01653327 record still lists
NCT01653327 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01653327 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01653327 about?
NCT01653327 is a clinical study titled "Analgesic Effects of Topical Ketamine Mouthwash in Patients Receiving Chemoradiation or Radiotherapy for Head & Neck Cancer". * The primary objective is to determine the reduction in pain score by ketamine mouthwash compared to placebo in head and neck cancer patients with refractory mucositis. * The secondary objectives are to describe the duration of analgesia and adverse effects associated with ketamine and placebo.
What is the current status of trial NCT01653327?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 11 participants. The study started on 2010-06. Estimated completion is 2016-08-16.
What interventions are being tested in trial NCT01653327?
The interventions under investigation include: Placebo (DRUG), Ketamine (DRUG).
Who is sponsoring clinical trial NCT01653327?
This trial is sponsored by Dartmouth-Hitchcock Medical Center, which has 427 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01653327's enrollment target sits among peer trials
11 1967th of 2000 higher than 33 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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