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Compare Fentanyl Nasal Spray With Intravenous Opioids to Treat Severe Pain

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ClinicalTrials.gov Identifier: NCT02459964
Recruitment Status : Active, not recruiting
First Posted : June 2, 2015
Last Update Posted : August 22, 2018
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

Condition or disease Intervention/treatment Phase
Advanced Cancers Pain Drug: Fentanyl Nasal Spray Drug: Hydromorphone Hydrochloride Behavioral: Phone Call Phase 4

Detailed Description:

Study Groups and Drug Administration:

If participant agrees to take part in this study, they will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. This is done because no one knows if one study group is better, the same, or worse than the other group. Participant will have an equal chance of being in either group:

  • If participant is in Group 1, they will receive the fentanyl nasal spray. The study staff will help participant use the nasal spray.
  • If participant is in Group 2, the emergency center nurse will give them the hydromorphone hydrochloride by vein.

Study Procedures:

Participant will stay in the emergency department for at least 4 hours and will be monitored after receiving fentanyl or hydromorphone hydrochloride. During this time, participant will be asked about their pain and any side effects they may be having every 15 minutes for 2 hours and then every 30 minutes for another 2 hours. The study staff will also monitor participant's vital signs, and ask them a few more questions at the end of the study.

Length of Study Participation:

Although participant will stay in the emergency department for at least 4 hours, the average length of stay for participants with severe pain is about 9 hours. When participant is discharged from the emergency department or admitted to the hospital, their active participation in the study is over.

Follow-Up Phone Call:

About 24 hours after patient's active participation is over, the study nurse will call them to ask if they had any other side effects since taking part in the study. The phone call should last about 5 minutes. If participant is still an inpatient at the hospital, the study nurse may visit them and ask them these questions in person.

This is an investigational study. Hydromorphone hydrochloride is FDA approved and commercially available for the treatment of pain. Fentanyl nasal spray is FDA approved and commercially available for the treatment of pain. Its use to help with cancer pain in the emergency department is investigational.

Up to 84 participants will be enrolled in this study. All will take part at MD Anderson.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Randomized Trial to Compare Fentanyl Nasal Spray With Intravenous Opioids to Treat Severe Pain in Cancer Patients in the Emergency Department Setting
Actual Study Start Date : September 14, 2015
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Fentanyl Nasal Spray

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
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)

Behavioral: Phone Call
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.

Active Comparator: Hydromorphone Hydrochloride

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
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).

Behavioral: Phone Call
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.




Primary Outcome Measures :
  1. Non-Inferiority of Nasal Fentanyl versus Hydromorphone Hydrochloride: mean change in Numeric Rating Scale (NRS) pain scores [ Time Frame: Every 15 minutes for 2 hours, then every 30 minutes for another 2 hours ]
    Mean change in pain intensity from treatment initiation until one hour after treatment initiation compared between the two arms. Non-inferiority evaluated by testing whether the lower bound of the 90% CI for difference in pain change scores is greater than -0.9, the margin of equivalence. Specifically, the mean change in Numeric Rating Scale (NRS) pain scores (assessed on an 11-point Likert scale with 0 = no pain and 10 = worst pain) from treatment initiation to one hour post-initiation calculated for both groups. Group difference in pain change scores (mean pain change in the fentanyl group minus that in the IV hydromorphone group) and the associated two-sided 95% CI for the difference estimated. Non-inferiority of nasal fentanyl over IV hydromorphone concluded if the lower bound of the 90% CI around the estimated difference in pain score change lies above -0.9 points.


Secondary Outcome Measures :
  1. Change in Numeric Rating Scale (NRS) Pain Scores [ Time Frame: 1 hour after randomization ]
    Secondary efficacy endpoint is the change in NRS pain scores from randomization to one hour after randomization, summarized using mean, standard deviation, minimum, median and maximum values. A two-sample t-test used to assess group difference in pain score change. In addition, analysis of covariance used to determine whether significant differences exist between the nasal fentanyl and IV hydromorphone groups in pain intensity scores at one hour post randomization with treatment group (fentanyl vs. IV hydromorphone) and baseline pain intensity included as independent variables.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. 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.)
  3. Ability and willingness to communicate the intensity of pain using NRS at the frequency dictated by the protocol

Exclusion Criteria:

  1. Patients with a history of chronic active hepatitis, cirrhosis or hepatic encephalopathy
  2. Inability to give informed consent
  3. Known or suspected hypersensitivity or intolerance to fentanyl or hydromorphone or excipients in the study medications
  4. 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.
  5. Females who are pregnant, breast-feeding or intending to become pregnant. This exclusion criterion will be assessed by questioning the patient about the pregnancy status, breast-feeding status, the intent to become pregnant, the menopausal status, and the date of the last menstrual period.
  6. 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)
  7. Previous participation in randomization in this trial
  8. Has taken oral immediate release opioids within 4 hours prior to arrival.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02459964


Locations
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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
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Principal Investigator: Sai-Ching J. Yeung, MD, PHD M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02459964     History of Changes
Other Study ID Numbers: 2015-0086
NCI-2015-01509 ( Registry Identifier: NCI CTRP )
First Posted: June 2, 2015    Key Record Dates
Last Update Posted: August 22, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Advanced Cancers
Pain
Fentanyl nasal spray
Hydromorphone hydrochloride
Phone call
Numeric Rating Scale
NRS

Additional relevant MeSH terms:
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Analgesics, Opioid
Fentanyl
Hydromorphone
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics