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NCT02514252 · ClinicalTrials.gov registry record · Phase 2

Sublingual Fentanyl for the Management of Breakthrough Pain

A Phase 2 study, sponsored by M.D. Anderson Cancer Center.

Terminated
Registry status
Phase 2
Development phase
6
Enrollment target

NCT02514252: Clinical Trial Phase 2 study, sponsored by M.D. Anderson Cancer Center.

NCT02514252 is a Phase 2 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 6 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02514252, a Phase 2 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.

TERMINATED
Registry status
Phase 2
Development phase
6 participants
Enrollment target

Study Summary

The goal of this clinical research study is to learn if an investigational dose of fentanyl sublingual spray (FSS) can help to control pain in patients with advanced cancer when given in an outpatient and inpatient setting.

Primary Outcome

To determine the effective dose of Fentanyl sublingual spray in the management of breakthrough pain (4 episodes) in hospitalized patients with advanced cancer receiving continuous opioid infusion in which the first starting dose would be proportional to the patients Morphine Equivalent Daily Dose. It will use Alberta Breakthrough Pain assessment tool with 15 questions.

Interventions

  • BEHAVIORAL Questionnaires
  • BEHAVIORAL Mental Ability Tests
  • DRUG Fentanyl Sublingual Spray (FSS)
  • BEHAVIORAL Study Diary

Trial Details

FieldValue
Enrollment Target 6 participants
Start Date 2016-02-02
Est. Completion 2019-11-04
Phase Phase 2
M.D. Anderson Cancer Center

2,692 total trials

Why NCT02514252 stopped before completion

NCT02514252 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).

The record links to 0 conditions, and to 4 interventions - of which Questionnaires is the first listed.

NCT02514252 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02514252 about?

NCT02514252 is a clinical study titled "Sublingual Fentanyl for the Management of Breakthrough Pain". The goal of this clinical research study is to learn if an investigational dose of fentanyl sublingual spray (FSS) can help to control pain in patients with advanced cancer when given in an outpatient and inpatient setting.

What is the current status of trial NCT02514252?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 6 participants. The study started on 2016-02-02. Estimated completion is 2019-11-04.

What interventions are being tested in trial NCT02514252?

The interventions under investigation include: Questionnaires (BEHAVIORAL), Mental Ability Tests (BEHAVIORAL), Fentanyl Sublingual Spray (FSS) (DRUG), Study Diary (BEHAVIORAL).

Who is sponsoring clinical trial NCT02514252?

This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02514252's enrollment target sits among peer trials

6 1996th of 2000 higher than 1 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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Source: ClinicalTrials.gov NCT02514252, the US trial registry maintained by the National Library of Medicine. NCT02514252 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.