PainPhase 3NCT00293033

Study of BEMA™ Fentanyl in the Treatment of Breakthrough Pain in Cancer Subjects

A Phase 3 study testing BEMA™ in people with Pain and Cancer, run by BioDelivery Sciences International at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Pain, Cancer
What is being tested?: BEMA™
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 152 participants
Where: 1 siteUnited States
Study dates: Feb 2006to Apr 2007
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or non-pregnant and non-lactating female. A female of child-bearing potential is eligible to participate in this study if she is using an acceptable method of birth control.
18 years or older
Patient must have pain associated with cancer or cancer treatment.
Patient must be on a stable current regimen of oral opioids equivalent to 60 - 1000 mg/day of oral morphine or 50 - 300 µg/hr of transdermal fentanyl (e.g. oxycodone 30 mg, methadone 20 mg, and hydromorphone 7.5 mg).
Regularly experiences 1 - 4 breakthrough pain episodes per day that require additional opioids for pain control
At least partial relief of breakthrough pain by use of opioid therapy

Show all 9Show fewer

Subject must be able to self-administer the study medication correctly.
Subject must be willing and able to complete the electronic diary card with each pain episode.
Signed consent must be obtained at screening prior to any procedures being performed.

Who cannot join

Psychiatric/cognitive or neurological impairment that would limit the subject's ability to understand or complete the diary
Cardiopulmonary disease that, in the opinion of the investigator, would significantly increase the risk of respiratory depression
Recent history or current evidence of alcohol or other drug substance (licit or illicit) abuse
Rapidly escalating pain that the investigator believes may require an increase in the dosage of background pain medication during the study
Moderate (Grade 3) to severe (Grade 4) mucositis (Subjects with less than moderate mucositis are permitted and must be instructed to not apply the BEMA disc at a site of inflammation.)
Strontium 89 therapy within the previous 6 months

Show all 12Show fewer

Any other therapy prior to the study that the investigator considers could alter pain or the response to pain medication.
Use of an investigational drug within 4 weeks preceding this study
History of hypersensitivity or intolerance to fentanyl
Regularly more than 4 episodes per day
Eastern Cooperative Oncology Group (ECOG) performance status of 4 or 5
Subject is pregnant, actively trying to become pregnant, breast feeding or not using adequate contraceptive measures

Trial locations and contacts

1 site in 1 country.

United States1 site

PPD Development
Wilmington, North Carolina, 28412

Other trials in United States

About this study

Official title: A Double-blind, Placebo Controlled Evaluation of the Efficacy, Safety and Tolerability of BEMA™ Fentanyl in the Treatment of Breakthrough Pain in Cancer Subjects

The purpose of this study is to evaluate the efficacy of BEMA Fentanyl (Onsolis) at any dose in the management of breakthrough pain in cancer subjects on background opioid therapy. The standard of care for these breakthrough pain episodes is a rapid onset, short acting analgesic with minimal associated sleepiness. Oral morphine, oxycodone and hydromorphone are routinely used, but because of slow and variable oral absorption, the pain control is not the best with these products. Oral transmucosal fentanyl citrate (OTFC) has been used successfully in treating breakthrough pain episodes associated with cancer. OTFC is a lozenge of fentanyl on a stick and is administered by continuously swabbing the interior of the subject's mouth until the product is dissolved (approximately 15 to 30 minutes). The buccal route of administration avoids the delay and variability associated with oral absorption.

Read the detailed description

This is a randomized, double-blind, placebo controlled, multiple cross-over study. Eligible subjects will be treated with open label BEMA fentanyl over a period of up to two weeks. Doses will be titrated upward, starting at 200 μg, until a dose is identified that produces satisfactory pain relief for at least 2 episodes. Those subjects who identify a dose of BEMA fentanyl that produces satisfactory relief of breakthrough pain episodes will enter the double-blind, placebo controlled period of the trial. They will receive 3 placebo doses and 6 BEMA fentanyl doses in a random sequence per randomization schedule.

Conditions: Pain, Cancer
Being tested: BEMA™, Placebo
Keywords: Breakthrough Pain in Patients with Cancer
Medical subject headings: Pain, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BEMA™Drug
Also called Onsolis (fentanyl buccal soluble film)
BioDelivery Sciences International, Inc. (BDSI) has developed BioErodible MucoAdhesive (BEMA) Fentanyl, an alternative product to OTFC that does not require the subject to continuously paint the inside of the mouth with the dosage form. The BDSI product is a small soluble film that is placed against the mucosal membrane inside the mouth. The mucoadhesive polymers in the film readily adhere to the mucosal membrane (within 5 seconds) when moistened. The components of the film are water soluble, so the entire dosage form dissolves within 30 minutes of application.
PlaceboDrug

Study groups in NCT00293033
Study group	Role	What they receive
Placebo	Placebo comparator	Placebo Receives: Drug: BEMA™; Drug: Placebo
BEMA™ Fentanyl	Experimental	BioErodible MucoAdhesive (BEMA) Fentanyl Receives: Drug: BEMA™

What is being measured

The primary outcome is the main question the study is designed to answer.

Summary of Pain Intensity Differences (SPID)
Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point. The primary endpoint was the Summary of Pain Intensity Differences at 30 minutes after dosing (SPID 30) in ITT population for Onsolis versus placebo during double-blind period of study. SPID was calculated as a weighted sum of the PID of all time points at or before time point of interest.Range of possible SPID values is
-10X time point (minutes) to 10X time point (minutes). Higher value indicates a better outcome.
Measured: 0-30 minutes

Secondary outcomes (45)

SPID
Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point. The primary endpoint was the Summary of Pain Intensity Differences at 30 minutes after dosing (SPID 30) in ITT population for Onsolis versus placebo during double-blind period of study. SPID was calculated as a weighted sum of the PID of all time points at or before time point of interest.Range of possible SPID values is -10X time point (minutes) to 10X time point (minutes). Higher value indicates a better outcome.SPID was calculated as a weighted sum of the pain intensity difference of all time points at or before the time point of interest.
Measured: 0-5 minutes
SPID
Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point. The primary endpoint was the Summary of Pain Intensity Differences at 30 minutes after dosing (SPID 30) in ITT population for Onsolis versus placebo during double-blind period of study. SPID was calculated as a weighted sum of the PID of all time points at or before time point of interest.Range of possible SPID values is -10X time point (minutes) to 10X time point (minutes). Higher value indicates a better outcome.SPID was calculated as a weighted sum of the pain intensity difference of all time points at or before the time point of interest.
Measured: 0-10 minutes
SPID
Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point. The primary endpoint was the Summary of Pain Intensity Differences at 30 minutes after dosing (SPID 30) in ITT population for Onsolis versus placebo during double-blind period of study. SPID was calculated as a weighted sum of the PID of all time points at or before time point of interest.Range of possible SPID values is -10X time point (minutes) to 10X time point (minutes). Higher value indicates a better outcome.SPID was calculated as a weighted sum of the pain intensity difference of all time points at or before the time point of interest.
Measured: 0-15 minutes
SPID
Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point. The primary endpoint was the Summary of Pain Intensity Differences at 30 minutes after dosing (SPID 30) in ITT population for Onsolis versus placebo during double-blind period of study. SPID was calculated as a weighted sum of the PID of all time points at or before time point of interest.Range of possible SPID values is -10X time point (minutes) to 10X time point (minutes). Higher value indicates a better outcome.SPID was calculated as a weighted sum of the pain intensity difference of all time points at or before the time point of interest.
Measured: 0-45 minutes
SPID
Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point. The primary endpoint was the Summary of Pain Intensity Differences at 30 minutes after dosing (SPID 30) in ITT population for Onsolis versus placebo during double-blind period of study. SPID was calculated as a weighted sum of the PID of all time points at or before time point of interest.Range of possible SPID values is -10X time point (minutes) to 10X time point (minutes). Higher value indicates a better outcome.SPID was calculated as a weighted sum of the pain intensity difference of all time points at or before the time point of interest.
Measured: 0-60 minutes
PID
Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point.
Measured: 5 minutes after dosing
PID
Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point.
Measured: 10 minutes after dosing
PID
Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point.
Measured: 15 minutes after dosing
PID
Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point.
Measured: 30 minutes after dosing
PID
Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point.
Measured: 45 minutes after dosing
PID
Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point.
Measured: 60 minutes after dosing
Pain Relief
Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief) at 5, 10, 15, 30, 45, and 60 minutes after taking the study medication or until rescue.
Measured: 5 minutes after dosing
Pain Relief
Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief) at 5, 10, 15, 30, 45, and 60 minutes after taking the study medication or until rescue.
Measured: 10 minutes after dosing
Pain Relief
Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief) at 5, 10, 15, 30, 45, and 60 minutes after taking the study medication or until rescue.
Measured: 15 minutes after dosing
Pain Relief
Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief) at 5, 10, 15, 30, 45, and 60 minutes after taking the study medication or until rescue.
Measured: 30 minutes after dosing
Pain Relief
Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief) at 5, 10, 15, 30, 45, and 60 minutes after taking the study medication or until rescue.
Measured: 45 minutes after dosing
Pain Relief
Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief) at 5, 10, 15, 30, 45, and 60 minutes after taking the study medication or until rescue.
Measured: 60 minutes after dosing
Total Pain Relief
Total Pain Relief (TOTPAR) is calculated as the weighted sum of the pain relief (PR) of all time points at or prior to the time point of interest.Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief)compared to baseline (pre-dose)
Measured: 5 minutes
Total Pain Relief
Total Pain Relief (TOTPAR) is calculated as the weighted sum of the pain relief (PR) of all time points at or prior to the time point of interest. Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief)compared to baseline (pre-dose)
Measured: 10 minutes
Total Pain Relief
Total Pain Relief (TOTPAR) is calculated as the weighted sum of the pain relief (PR) of all time points at or prior to the time point of interest. Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief)compared to baseline (pre-dose)
Measured: 15 minutes
Total Pain Relief
Total Pain Relief (TOTPAR) is calculated as the weighted sum of the pain relief (PR) of all time points at or prior to the time point of interest. Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief)compared to baseline (pre-dose)
Measured: 30 minutes
Total Pain Relief
Total Pain Relief (TOTPAR) is calculated as the weighted sum of the pain relief (PR) of all time points at or prior to the time point of interest. Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief)compared to baseline (pre-dose)
Measured: 45 minutes
Total Pain Relief
Total Pain Relief (TOTPAR) is calculated as the weighted sum of the pain relief (PR) of all time points at or prior to the time point of interest. Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief)compared to baseline (pre-dose)
Measured: 60 minutes
Subject Overall Satisfaction With Study Drug
Subjects evaluated their overall satisfaction with study drug at the time rescue medication was consumed or at the 60-minute time point using a 5-point categorical scale (0 = poor, 1 = fair, 2 = good, 3 = very good, and 4 = excellent).
Measured: 60 minutes or at time of rescue medication use
Percentage of Pain Free Episodes
A pain free episode is one with 0 pain intensity at the specified time point. Percentage of episodes that are pain-free per subject is analyzed.
Measured: 5 minutes
Percentage of Pain Free Episodes
A pain free episode is one with 0 pain intensity at the specified time point. Percentage of episodes that are pain-free per subject is analyzed.
Measured: 10 minutes
Percentage of Pain Free Episodes
A pain free episode is one with 0 pain intensity at the specified time point. Percentage of episodes that are pain-free per subject is analyzed.
Measured: 15 minutes
Percentage of Pain Free Episodes
A pain free episode is one with 0 pain intensity at the specified time point. Percentage of episodes that are pain-free per subject is analyzed.
Measured: 30 minutes
Percentage of Pain Free Episodes
A pain free episode is one with 0 pain intensity at the specified time point. Percentage of episodes that are pain-free per subject is analyzed.
Measured: 45 minutes
Percentage of Pain Free Episodes
A pain free episode is one with 0 pain intensity at the specified time point. Percentage of episodes that are pain-free per subject is analyzed.
Measured: 60 minutes
Episodes With at Least 50% Decreases in Pain
Number of episodes where the total pain score has at least a 50% reduction from baseline.
Measured: 15 minutes
Episodes With at Least 50% Decreases in Pain
Number of episodes where the total pain score has at least a 50% reduction from baseline.
Measured: 30 minutes
Episodes With at Least 50% Decreases in Pain
Number of episodes where the total pain score has at least a 50% reduction from baseline.
Measured: 45 minutes
Episodes With at Least 50% Decreases in Pain
Number of episodes where the total pain score has at least a 50% reduction from baseline.
Measured: 60 minutes
Episodes With at Least 33% Decreases in Pain
Number of episodes where the total pain score has at least a 33% reduction from baseline.
Measured: 15 minutes
Episodes With at Least 33% Decreases in Pain
Number of episodes where the total pain score has at least a 33% reduction from baseline.
Measured: 30 minutes
Episodes With at Least 33% Decreases in Pain
Number of episodes where the total pain score has at least a 33% reduction from baseline.
Measured: 45 minutes
Episodes With at Least 33% Decreases in Pain
Number of episodes where the total pain score has at least a 50% reduction from baseline.
Measured: 60 minutes
Episodes With Complete Pain Relief
Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief). Percentage of episodes with complete relief per subject is analyzed where a complete pain relief episode is defined as pain relief of value 4 at the specified time point.
Measured: 5 minutes
Episodes With Complete Pain Relief
Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief).Percentage of episodes with complete relief per subject is analyzed where a complete pain relief episode is defined as pain relief of value 4 at the specified time point.
Measured: 10 minutes
Episodes With Complete Pain Relief
Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief).Percentage of episodes with complete relief per subject is analyzed where a complete pain relief episode is defined as pain relief of value 4 at the specified time point.
Measured: 15 minutes
Episodes With Complete Pain Relief
Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief). Percentage of episodes with complete relief per subject is analyzed where a complete pain relief episode is defined as pain relief of value 4 at the specified time point.
Measured: 30 minutes
Episodes With Complete Pain Relief
Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief). Percentage of episodes with complete relief per subject is analyzed where a complete pain relief episode is defined as pain relief of value 4 at the specified time point.
Measured: 45 minutes
Episodes With Complete Pain Relief
Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief). Percentage of episodes with complete relief per subject is analyzed where a complete pain relief episode is defined as pain relief of value 4 at the specified time point.
Measured: 60 minutes
Rescue Medication Usage
Rescue medication is medication taken if adequate pain relief is not realized within 30 minutes following application of the study drug. Percentage of episodes when rescue medication was used per subject is analyzed.
Measured: 28 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2006Apr 2007

First posted17 Feb 2006 (estimated)
Study startFeb 2006
Primary completionApr 2007
Study completionApr 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 152 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00293033
Sponsor's protocol ID: FEN-201
Status last verified: Nov 2019
First submitted: 15 Feb 2006
Last updated: 18 Nov 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain

All Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-blind, Placebo Controlled Evaluation of the Efficacy, Safety and Tolerability of BEMA™ Fentanyl in the Treatment of Breakthrough Pain in Cancer Subjects
ClinicalTrials.gov ID: NCT00293033
Acronym / sponsor ID: FEN-201
Conditions: Pain, Cancer
Keywords: Breakthrough Pain in Patients with Cancer
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 152 participants (actual)
Lead sponsor: BioDelivery Sciences InternationalIndustry (pharma, biotech, devices)
Study start: Feb 2006
Primary completion: Apr 2007 (actual)
Study completion: Apr 2007 (actual)
First posted: 17 Feb 2006 (estimated)
Results: Posted 21 Oct 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Placebo	Placebo comparator	Drug: BEMA™, Drug: PlaceboPlacebo
BEMA™ Fentanyl	Experimental	Drug: BEMA™BioErodible MucoAdhesive (BEMA) Fentanyl

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Male or non-pregnant and non-lactating female. A female of child-bearing potential is eligible to participate in this study if she is using an acceptable method of birth control.
18 years or older
Patient must have pain associated with cancer or cancer treatment.
Patient must be on a stable current regimen of oral opioids equivalent to 60 - 1000 mg/day of oral morphine or 50 - 300 µg/hr of transdermal fentanyl (e.g. oxycodone 30 mg, methadone 20 mg, and hydromorphone 7.5 mg).
Regularly experiences 1 - 4 breakthrough pain episodes per day that require additional opioids for pain control

Key exclusion criteria (12 listed)

Psychiatric/cognitive or neurological impairment that would limit the subject's ability to understand or complete the diary
Cardiopulmonary disease that, in the opinion of the investigator, would significantly increase the risk of respiratory depression
Recent history or current evidence of alcohol or other drug substance (licit or illicit) abuse
Rapidly escalating pain that the investigator believes may require an increase in the dosage of background pain medication during the study
Moderate (Grade 3) to severe (Grade 4) mucositis (Subjects with less than moderate mucositis are permitted and must be instructed to not apply the BEMA disc at a site of inflammation.)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BEMA™Also: Onsolis (fentanyl buccal soluble film)BioDelivery Sciences International, Inc. (BDSI) has developed BioErodible MucoAdhesive (BEMA) Fentanyl, an alternative product to OTFC that does not require the subject to continuously paint the inside of the mouth with the dosage form. The BDSI product is a small soluble film that is placed against the mucosal membrane inside the mouth. The mucoadhesive polymers in the film readily adhere to the mucosal membrane (within 5 seconds) when moistened. The components of the film are water soluble, so the entire dosage form dissolves within 30 minutes of application.	Drug	BEMA™ Fentanyl, Placebo
Placebo	Drug	Placebo

Primary outcome

Summary of Pain Intensity Differences (SPID)
Time frame: 0-30 minutes
Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point. The primary endpoint was the Summary of Pain Intensity Differences at 30 minutes after dosing (SPID 30) in ITT population for Onsolis versus placebo during double-blind period of study. SPID was calculated as a weighted sum of the PID of all time points at or before time point of interest.Range of possible SPID values is -10X time point (minutes) to 10X time point (minutes). Higher value indicates a better outcome.

45 secondary outcomes

SPID
Time frame: 0-5 minutes
SPID
Time frame: 0-10 minutes
SPID
Time frame: 0-15 minutes
SPID
Time frame: 0-45 minutes
SPID
Time frame: 0-60 minutes
PID
Time frame: 5 minutes after dosing
PID
Time frame: 10 minutes after dosing
PID
Time frame: 15 minutes after dosing
PID
Time frame: 30 minutes after dosing
PID
Time frame: 45 minutes after dosing
PID
Time frame: 60 minutes after dosing
Pain Relief
Time frame: 5 minutes after dosing
Pain Relief
Time frame: 10 minutes after dosing
Pain Relief
Time frame: 15 minutes after dosing
Pain Relief
Time frame: 30 minutes after dosing
Pain Relief
Time frame: 45 minutes after dosing
Pain Relief
Time frame: 60 minutes after dosing
Total Pain Relief
Time frame: 5 minutes
Total Pain Relief
Time frame: 10 minutes
Total Pain Relief
Time frame: 15 minutes
Total Pain Relief
Time frame: 30 minutes
Total Pain Relief
Time frame: 45 minutes
Total Pain Relief
Time frame: 60 minutes
Subject Overall Satisfaction With Study Drug
Time frame: 60 minutes or at time of rescue medication use
Percentage of Pain Free Episodes
Time frame: 5 minutes
Percentage of Pain Free Episodes
Time frame: 10 minutes
Percentage of Pain Free Episodes
Time frame: 15 minutes
Percentage of Pain Free Episodes
Time frame: 30 minutes
Percentage of Pain Free Episodes
Time frame: 45 minutes
Percentage of Pain Free Episodes
Time frame: 60 minutes
Episodes With at Least 50% Decreases in Pain
Time frame: 15 minutes
Episodes With at Least 50% Decreases in Pain
Time frame: 30 minutes
Episodes With at Least 50% Decreases in Pain
Time frame: 45 minutes
Episodes With at Least 50% Decreases in Pain
Time frame: 60 minutes
Episodes With at Least 33% Decreases in Pain
Time frame: 15 minutes
Episodes With at Least 33% Decreases in Pain
Time frame: 30 minutes
Episodes With at Least 33% Decreases in Pain
Time frame: 45 minutes
Episodes With at Least 33% Decreases in Pain
Time frame: 60 minutes
Episodes With Complete Pain Relief
Time frame: 5 minutes
Episodes With Complete Pain Relief
Time frame: 10 minutes

Results and safety

Results posted to the registry on 21 Oct 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Onsolis	151	82

Primary outcome: Summary of Pain Intensity Differences (SPID)

Time frame: 0-30 minutes. Least squares mean (Standard Error). Unit: Score on a scale

Measure	Onsolis n = 79	Placebo n = 77
Value	47.9 (3.87)	38.1 (4.3)

Onsolis vs Placebo: Mean Difference (Final Values): 9.74 (95% CI 3.31 to 16.18), p = 0.004, Mixed Models Analysis

Population analysed: In double-blind period, subjects received 3 doses placebo and 6 doses Onsolis. Mean SPID of Onsolis episodes and mean SPID of placebo episodes are calculated per subject and are used in analysis.Missing data were imputed on an episode-by-episode basis by carrying forward last observed data value (last observation carried forward \[LOCF\]).

45 secondary outcomes are reported in the full results.

Adverse events

Time frame: A prior-treatment adverse event (AE) was defined as an AE that began before the first dose of the study drug. A treatment-emergent AE was defined as an AE that began on or after the initial dose of study medication up until the Follow-up Visit on Day 29.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Onsolis	23 of 151 (15.2%)	44 of 151 (29.1%)	Not reported

Limitations and caveats (from the sponsor): There were no limitations or caveats.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Pain

Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Andrew Finn, PharmD study chair

BioDelivery Sciences International

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BEMA™ in people with Pain and Cancer, run by BioDelivery Sciences International at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Summary of Pain Intensity Differences (SPID) (time frame: 0-30 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00293033.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2019; AzTrials last refreshed its copy on 8 Nov 2026.