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Fentanyl for Breakthrough Pain in the Emergency Department

NCT01812759 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2021-06-29

Study results available
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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.

Conditions

Interventions

DRUG

Fentanyl Nasal Spray

100 mcg nasal spray administered in each nostril.

DRUG

Hydromorphone PCA

Initial loading dose 0.2 mg with demand doses of 0.2 mg and lockout interval of 15 minutes. There will be no basal dose and the 8-hour dose limit will be 6.4 mg.

OTHER

Placebo Nasal Spray

1 placebo nasal spray administered in each nostril.

Sponsors & Collaborators

  • Archimedes Pharma US, Inc.

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Knox H. Todd, MD · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-10
Primary Completion
2014-10-22
Completion
2014-10-22
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01812759 on ClinicalTrials.gov