Sublingual Fentanyl for the Management of Breakthrough Pain
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02514252|
Recruitment Status : Active, not recruiting
First Posted : August 3, 2015
Last Update Posted : May 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|Advanced Cancers||Drug: Fentanyl Sublingual Spray (FSS) Behavioral: Questionnaires Behavioral: Mental Ability Tests Behavioral: Study Diary||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
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.
- 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.
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
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Suresh Reddy, MD||M.D. Anderson Cancer Center|