Status:
TERMINATED
Fentanyl for Breakthrough Pain in the Emergency Department
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Archimedes Pharma US, Inc.
Conditions:
Pain
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief 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 ca...
Detailed Description
Study Groups: If you agree to take part in this study, you will be randomly assigned (as in the flip of a coin) to receive either fentanyl nasal spray or a placebo nasal spray. You will have an equal...
Eligibility Criteria
Inclusion
- Cancer patients presenting to the Emergency Department for treatment of acute breakthrough pain who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. (Patients considered opioid tolerant are those who are taking at least: 60 mg of oral morphine/day, 25 mcg of transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day, or an equianalgesic dose of another opioid for a week or longer.)
- Patients must have severe pain on an 11-point Numeric Rating Scale (NRS 7-10)
- Breakthrough cancer pain must be of sufficient severity to warrant the use of intravenous opioids in the judgment of the treating emergency physician
- Age between 18 and 75 years
- Able to understand the description of the study and give informed consent
- Patients must be willing to and capable of providing frequent pain assessments for up to 8 hours
- English-speaking
Exclusion
- Patients will not be approached while they are in acute distress and those exhibiting symptoms (such as dyspnea, uncontrolled nausea/vomiting or vertigo) to such an extent that impairs their ability to understand and evaluate informed consent
- Patients participating in other clinical trials for pain
- Patients who are not already tolerant to opioids
- Patients, who in the judgment of the treating clinician, are suspected to have hepatic or renal failure
- Patients who are pregnant or lactating
- Patients with a known allergy or significant reaction to fentanyl, the components of the IN formulation, hydromorphone, or other opioids
- Patients already on high morphine equivalent daily dose (MEDDs) (\>500 mg/day).
Key Trial Info
Start Date :
January 10 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 22 2014
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT01812759
Start Date
January 10 2014
End Date
October 22 2014
Last Update
June 29 2021
Active Locations (1)
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1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030