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NCT02531906 · ClinicalTrials.gov registry record · Phase 1
Gabapentin, Methadone Hydrochloride, and Oxycodone Hydrochloride in Improving Quality of Life in Patients With Stage II-IV Head and Neck Cancer During Chemoradiation
A Phase 1 study, sponsored by Roswell Park Cancer Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
NCT02531906: Completed Phase 1 study, sponsored by Roswell Park Cancer Institute.
NCT02531906 is a Phase 1 study that has completed, run by Roswell Park Cancer Institute. The registered enrollment target is 60 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02531906, a Phase 1 study, has completed, sponsored by Roswell Park Cancer Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
Study Summary
This randomized pilot clinical trial studies the side effects of gabapentin and how well it works when given together with methadone hydrochloride and oxycodone hydrochloride in improving quality of life in patients with stage II-IV head and neck cancer during chemoradiation. Gabapentin, methadone hydrochloride, and oxycodone hydrochloride may help relieve moderate or severe pain caused by head and neck cancer during and after chemoradiation therapy.
Primary Outcome
Evaluated using a repeated measures model. Tested using a two-sided 0.05 significance level. Post hoc analyses will be done with multiple comparisons adjusted for using the Bonferroni method. Assumptions of normality and equal variance will be examined, and transformations will be used as appropriate.
Interventions
- OTHER Quality-of-Life Assessment
- OTHER Questionnaire Administration
- DRUG Gabapentin
- DRUG Methadone Hydrochloride
- DRUG Oxycodone Hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2015-04-24 |
| Est. Completion | 2018-06-14 |
| Phase | Phase 1 |
What the finished NCT02531906 record still lists
NCT02531906 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 5 interventions - of which Quality-of-Life Assessment is the first listed.
NCT02531906 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02531906 about?
NCT02531906 is a clinical study titled "Gabapentin, Methadone Hydrochloride, and Oxycodone Hydrochloride in Improving Quality of Life in Patients With Stage II-IV Head and Neck Cancer During Chemoradiation". This randomized pilot clinical trial studies the side effects of gabapentin and how well it works when given together with methadone hydrochloride and oxycodone hydrochloride in improving quality of life in patients with stage II-IV head and neck cancer during chemoradiation. Gabapentin, methadone h...
What is the current status of trial NCT02531906?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2015-04-24. Estimated completion is 2018-06-14.
What interventions are being tested in trial NCT02531906?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Questionnaire Administration (OTHER), Gabapentin (DRUG), Methadone Hydrochloride (DRUG), Oxycodone Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT02531906?
This trial is sponsored by Roswell Park Cancer Institute, which has 365 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02531906's enrollment target sits among peer trials
60 831st of 2000 higher than 1,106 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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