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Trial record 56 of 56 for:    insys

Sublingual Fentanyl for the Management of Breakthrough Pain

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ClinicalTrials.gov Identifier: NCT02514252
Recruitment Status : Active, not recruiting
First Posted : August 3, 2015
Last Update Posted : May 23, 2019
Sponsor:
Collaborator:
INSYS Therapeutics Inc
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
The goal of this clinical research study is to learn if an investigational dose of fentanyl sublingual spray (FSS) can help to control pain in patients with advanced cancer when given in an outpatient and inpatient setting.

Condition or disease Intervention/treatment Phase
Advanced Cancers Drug: Fentanyl Sublingual Spray (FSS) Behavioral: Questionnaires Behavioral: Mental Ability Tests Behavioral: Study Diary Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Preliminary Study of Sublingual Fentanyl for the Management of Breakthrough Pain Analgesia in Patients With Advanced Cancer
Actual Study Start Date : February 2, 2016
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Fentanyl Sublingual Spray (FSS)
Hospitalized participants asked to complete a number of surveys at baseline. Participants then receive one single dose of intravenous opioid rescue for their first episode of breakthrough pain, and then receive up to 4 doses of FSS for subsequent episodes of breakthrough pain. Initial FSS starting dose is proportional to the patient's morphine equivalent daily dose (MEDD). Symptom questionnaire completed at baseline and after last dose of FSS while hospitalized. Mental ability tests given while hospitalized 30 minutes after first dose of current pain medication, and 30 minutes after each FSS dose. At the time of discharge, if FSS was helpful in controlling participant's pain, they are then able to continue with FSS use for 1 month. Participants given study diary to document pain level, how many times FSS used, and any side effects experienced each day.
Drug: Fentanyl Sublingual Spray (FSS)

Stage 1: First Pain Episode - Single dose of breakthrough opioid given from existing PCA pump equivalent to 10% of their MEDD.

Second Pain Episode - Single dose of FSS equivalent to 16-32% of MEDD. If not effective at 30 minutes, participant repeats same dose one more time (with a cap of 1600 mcg total; i.e. dose given 30 minutes ago + dose now = 1600 mcg maximum.

Third Pain Episode (at least 4 hours after second episode) - Participant required 2 breakthrough FSS doses for the last episode of breakthrough pain, or if the effective dose has not been identified, he/she will double the last administered dose. If breakthrough pain not effective at 30 minutes, participant repeats same dose one more time (with a cap of 1600 mcg total; i.e. dose given 30 minutes ago + dose now = 1600 mcg maximum).

Stage 2: If FSS successful in hospital, upon discharge, FSS used as first choice of pain medication instead of oral pain medication for pain for up to 4 weeks.

Other Name: Fentanyl SL Spray

Behavioral: Questionnaires
Symptom questionnaire completed at baseline and after last dose of FSS while hospitalized. After Day 28, questionnaire completed over the phone about participant's opinion of research study.
Other Name: Surveys

Behavioral: Mental Ability Tests
Mental ability tests given while hospitalized 30 minutes after first dose of current pain medication, and 30 minutes after each FSS dose.

Behavioral: Study Diary
Participants given study diary to document pain level, how many times FSS used, and any side effects experienced each day.




Primary Outcome Measures :
  1. Effective Dose of Fentanyl Sublingual Spray (FSS) [ Time Frame: 1 month after hospital discharge ]
    Effective dose of FSS measured by % MEDD dose using descriptive statistics such as mean, standard deviation, and 95% confidence interval. Pattern of FSS effective dose such as episodes and number of doses summarized by tabulation.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with advanced cancer (locally advanced, metastatic, recurrent and/or incurable cancer).
  2. Opioid tolerant, taking daily doses of strong opioid pain medication in the past 1 week.
  3. On strong opioid intravenous continuous infusion MEDD >=70 mg/day at the time of enrollment.
  4. Inpatient at MD Anderson seen by palliative care team.
  5. Background cancer pain that is <=3/10 in the last 24 hours.
  6. Breakthrough cancer pain that is >=4/10 in the last 24 hours.
  7. Stable pain control defined as rescue doses <=6 in last 24 hours.
  8. Age >=18
  9. Ability to communicate in English

Exclusion Criteria:

  1. Memorial Delirium Assessment Scale >13/30
  2. History of opioid abuse
  3. CAGE positivity (>=2/4)
  4. Allergy to fentanyl
  5. Grade 2 or higher oral mucositis
  6. Unable/unwilling to sign consent

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): NCT02514252


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
INSYS Therapeutics Inc
Investigators
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Principal Investigator: Suresh Reddy, MD M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02514252     History of Changes
Other Study ID Numbers: 2015-0264
NCI-2015-01447 ( Registry Identifier: NCI CTRP )
First Posted: August 3, 2015    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: May 2019

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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
Metastatic
Recurrent cancer
Incurable cancer
Fentanyl sublingual spray
FSS
Questionnaires
Surveys
Mental ability tests
Phone calls
Study diary
Pain control
Additional relevant MeSH terms:
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Breakthrough Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Fentanyl
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics