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NCT00553059 · ClinicalTrials.gov registry record · Phase 3
Palonosetron and Dexamethasone With or Without Dronabinol in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy For Cancer
A Phase 3 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 3
- Development phase
- 62
- Enrollment target
NCT00553059: Completed Phase 3 study, sponsored by M.D. Anderson Cancer Center.
NCT00553059 is a Phase 3 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 62 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00553059, a Phase 3 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 62 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to learn if adding dronabinol in combination with the standard of care (dexamethasone and palonosetron) can better help to control nausea and vomiting in patients receiving chemotherapy. The safety of the drug combinations will also be studied.
Primary Outcome
Total protection is defined as no vomiting, no rescue therapy, and no nausea as indicated by responses to the acute (0-24 hour), delayed (24-120 hour), and overall (0-120 hour) periods as indicated by responses to the Daily Assessment of Nausea and Vomiting questionnaire. Data to be recorded in the study diary during the 5-day study period. The assessment measures in detail the occurrence, duration, and severity of post-chemotherapy nausea and emesis using a 10-point Likert-type scale ranging fr
Interventions
- OTHER placebo
- DRUG dexamethasone
- DRUG dronabinol
- DRUG palonosetron hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2008-05 |
| Est. Completion | 2014-08 |
| Phase | Phase 3 |
What the finished NCT00553059 record still lists
NCT00553059 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 4 interventions - of which placebo is the first listed.
NCT00553059 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00553059 about?
NCT00553059 is a clinical study titled "Palonosetron and Dexamethasone With or Without Dronabinol in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy For Cancer". The goal of this clinical research study is to learn if adding dronabinol in combination with the standard of care (dexamethasone and palonosetron) can better help to control nausea and vomiting in patients receiving chemotherapy. The safety of the drug combinations will also be studied.
What is the current status of trial NCT00553059?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 62 participants. The study started on 2008-05. Estimated completion is 2014-08.
What interventions are being tested in trial NCT00553059?
The interventions under investigation include: placebo (OTHER), dexamethasone (DRUG), dronabinol (DRUG), palonosetron hydrochloride (DRUG).
Who is sponsoring clinical trial NCT00553059?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00553059's enrollment target sits among peer trials
62 1802nd of 2000 higher than 198 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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