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NCT01812759 · ClinicalTrials.gov registry record · Phase 4
Fentanyl for Breakthrough Pain in the Emergency Department
A Phase 4 study, sponsored by M.D. Anderson Cancer Center.
- Terminated
- Registry status
- Phase 4
- Development phase
- 3
- Enrollment target
NCT01812759: Clinical Trial Phase 4 study, sponsored by M.D. Anderson Cancer Center.
NCT01812759 is a Phase 4 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 3 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01812759, a Phase 4 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 3 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to learn if fentanyl nasal spray can help decrease pain related to cancer when used with other drugs for pain. Researchers also want to know if this drug can help decrease the length of your stay in the Emergency Department. In this study, fentanyl nasal spray will be compared to a placebo nasal spray. A placebo is not a drug. It looks like the study drug but it is not designed to treat any disease or illness. It is designed in this study to be compared with the study spray to learn if the study spray has any real effect. You will also be given intravenous (IV) pain drugs. You will be given these drugs even if you decide not to take part in this study.
Primary Outcome
Primary outcome is total pain relief score (TOTPAR4) at 4 hours after treatment initiation. TOTPAR4 defined as the sum of hourly pain relief scores after baseline to four hours after the first administered dose of Lazanda or placebo. Scores range from -1 (worse pain) to 4 (complete relief). Range of possible TOTPAR4 summed scores is -4 to 16. A TOTPAR4 score greater than or equal to 8 is considered a positive response.
Interventions
- OTHER Placebo Nasal Spray
- DRUG Hydromorphone PCA
- DRUG Fentanyl Nasal Spray
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2014-01-10 |
| Est. Completion | 2014-10-22 |
| Phase | Phase 4 |
Why NCT01812759 stopped before completion
NCT01812759 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo Nasal Spray is the first listed.
NCT01812759 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01812759 about?
NCT01812759 is a clinical study titled "Fentanyl for Breakthrough Pain in the Emergency Department". The goal of this clinical research study is to learn if fentanyl nasal spray can help decrease pain related to cancer when used with other drugs for pain. Researchers also want to know if this drug can help decrease the length of your stay in the Emergency Department. In this study, fentanyl nasal ...
What is the current status of trial NCT01812759?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 3 participants. The study started on 2014-01-10. Estimated completion is 2014-10-22.
What interventions are being tested in trial NCT01812759?
The interventions under investigation include: Placebo Nasal Spray (OTHER), Hydromorphone PCA (DRUG), Fentanyl Nasal Spray (DRUG).
Who is sponsoring clinical trial NCT01812759?
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 NCT01812759's enrollment target sits among peer trials
3 1995th of 2000 higher than 3 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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