Compare Fentanyl Nasal Spray With Intravenous Opioids to Treat Severe Pain

NCT02459964 | Completed Phase 4 Results DMC FDA Drug

• 2 other identifiers: 2015-0086NCI-2015-01509
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is to compare fentanyl nasal spray with a standard drug given by vein (hydromorphone hydrochloride) to help reduce pain related to cancer in patients coming to the emergency department.

Conditions

Advanced Cancers; Pain

Keywords

Advanced Cancers; Pain; Fentanyl nasal spray; Hydromorphone hydrochloride; Phone call; Numeric Rating Scale; NRS

Outcome Measures

Primary Outcomes (1)

• Non-inferiority of Fentanyl Nasal Spray Versus Intravenous Opioids in the Change in the Numeric Rating Scale (NRS) Pain Intensity Score at One Hour, Starting From the Time of Drug Delivery (Treatment Initiation).

  The median change in Numeric Rating Scale (NRS) pain intensity scores (assessed on an 11-point Likert scale with 0 = no pain and 10 = worst pain) from randomization, estimate of treatment initiation, to one hour post-treatment calculated for both treatment arms.

  Baseline, One hour post time of drug delivery/treatment initiation

Secondary Outcomes (1)

• Number of Participants With Change in Numeric Rating Scale (NRS) Pain Intensity Score

  One (1) hour after treatment start.

Study Arms (2)

Fentanyl Nasal Spray

EXPERIMENTAL

Fentanyl nasal spray 100 mcg delivered at time 0 (defined as the time when intranasal Fentanyl spray is administered) with a rescue dose allowed at time 0.5 hour (h). Study nurse to call patient 24 hours after participation to ask about side effects since taking part in the study.

Drug: Fentanyl Nasal Spray; Behavioral: Phone Call

Hydromorphone Hydrochloride

ACTIVE COMPARATOR

Hydromorphone hydrochloride 1.5 mg pushed intravenously (IV) at time 0 (defined as the time of completion of opioid IV push) with a rescue dose allowed at time 0.5 hour (h). Study nurse to call patient 24 hours after participation to ask about side effects since taking part in the study.

Drug: Hydromorphone Hydrochloride; Behavioral: Phone Call

Interventions

Fentanyl Nasal Spray DRUG

Fentanyl nasal spray 100 mcg delivered at time 0 (defined as the time when intranasal Fentanyl spray is administered) with a rescue dose allowed at time 0.5 hour (h)

Fentanyl Nasal Spray

Hydromorphone Hydrochloride DRUG

Hydromorphone hydrochloride 1.5 mg pushed intravenously (IV) at time 0 (defined as the time of completion of opioid IV push) with a rescue dose allowed at time 0.5 hour (h).

Hydromorphone Hydrochloride

Phone Call BEHAVIORAL

Study nurse to call patient 24 hours after participation to ask about side effects since taking part in the study. The phone call should last about 5 minutes.

Fentanyl Nasal Spray; Hydromorphone Hydrochloride

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Cancer patients with severe pain (i.e., \>=7 on NRS, see Table 1) already on opioid therapy for one week or longer, at least 60 mg of oral morphine/day, 25 mcg of transdermal fentanyl/hour, 30 mg of oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day, or an equianalgesic dose of another opioid.
• Ability to give informed consent before any trial-related activities (Trial-related activities are any procedure that would not have been performed during normal management of the subject.)
• Ability and willingness to communicate the intensity of pain using NRS at the frequency dictated by the protocol

You may not qualify if:

• Patients with a history of chronic active hepatitis, cirrhosis or hepatic encephalopathy
• Inability to give informed consent
• Known or suspected hypersensitivity or intolerance to fentanyl or hydromorphone or excipients in the study medications
• Patients with sinusitis, obstruction of nasal passages, nasopharyngeal cancer, paranasal sinus malignancies, or any conditions in the nasopharyngeal anatomical area that may affect the absorption of fentanyl nasal spray.
• Females of child-bearing potential, who are not using adequate contraceptive measures (including condoms, birth control pills, intrauterine devices, contraceptive implants, or other US FDA-approved contraceptives)
• Previous participation in randomization in this trial
• Has taken oral immediate release opioids within 4 hours prior to arrival.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Banala SR, Khattab OK, Page VD, Warneke CL, Todd KH, Yeung SJ. Intranasal fentanyl spray versus intravenous opioids for the treatment of severe pain in patients with cancer in the emergency department setting: A randomized controlled trial. PLoS One. 2020 Jul 10;15(7):e0235461. doi: 10.1371/journal.pone.0235461. eCollection 2020.

  PMID: 32649717 DERIVED

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Pain

Interventions

Hydromorphone

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Sai-Ching J. Yeung, MD, Professor, Emergency Medicine
• Organization: UT MD Anderson Cancer Center

syeung@mdanderson.org

(713) 745-9911

Study Officials

• Sai-Ching J. Yeung, MD, PHD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2015
• First Posted: June 2, 2015
• Study Start: September 14, 2015
• Primary Completion: June 21, 2020
• Study Completion: June 21, 2020
• Last Updated: June 16, 2021
• Results First Posted: June 16, 2021

Record last verified: 2021-06

Locations

US (1)