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NCT01812759

Fentanyl for Breakthrough Pain in the Emergency Department

Terminated Phase 4 Results posted Last updated 29 June 2021
What this trial tests

Phase 4 trial testing Fentanyl Nasal Spray in Pain in 3 participants. Terminated before completion.

Timeline
10 January 2014
Primary endpoint
22 October 2014
22 October 2014

Quick facts

Lead sponsorM.D. Anderson Cancer Center
PhasePhase 4
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment3
Start date10 January 2014
Primary completion22 October 2014
Estimated completion22 October 2014
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

M.D. Anderson Cancer Center — full company profile →

Who can join

Adults 18 to 75, any sex, with Pain. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Total Pain Relief Score (TOTPAR4) at Four Hours After Treatment Initiation. Primary · 4 hours

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.

GroupValue95% CI
Placebo1
Intervention1
No Medication0

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other trials of Fentanyl Nasal Spray

Trials testing the same drug.

Other recruiting trials for Pain

Currently open trials in the same condition.

Other M.D. Anderson Cancer Center trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01812759.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing