Trial Outcomes & Findings for Longterm Safety Study of BEMA Buprenorphine in Subjects With Chronic Pain (NCT NCT01298765)
NCT ID: NCT01298765
Last Updated: 2018-08-07
Results Overview
The NRS Pain intensity score is a segmented version of a visual analog scale used to measure pain. The scale is from 0 (no pain) to 10. Scores between greater than 0 and 3 are considered mild pain, scores from greater than 3 to 6 are moderate and greater than 6 to 10 are severe. The daily average is calculated and used to calculate the change from baseline at week 52.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
302 participants
Primary outcome timeframe
Baseline up to approximately Week 52
Results posted on
2018-08-07
Participant Flow
Participant milestones
| Measure |
BEMA Buproneorphine Overall
buprenorphine buccal soluble film
BEMA Buprenorphine; buccal soluble film; applied to the buccal mucosa twice daily
|
|---|---|
|
Titration Period
STARTED
|
302
|
|
Titration Period
COMPLETED
|
226
|
|
Titration Period
NOT COMPLETED
|
76
|
|
Long-Term Treatment Period
STARTED
|
226
|
|
Long-Term Treatment Period
COMPLETED
|
127
|
|
Long-Term Treatment Period
NOT COMPLETED
|
99
|
Reasons for withdrawal
| Measure |
BEMA Buproneorphine Overall
buprenorphine buccal soluble film
BEMA Buprenorphine; buccal soluble film; applied to the buccal mucosa twice daily
|
|---|---|
|
Titration Period
Adverse Event
|
26
|
|
Titration Period
Death
|
1
|
|
Titration Period
Lack of Efficacy
|
21
|
|
Titration Period
Lost to Follow-up
|
9
|
|
Titration Period
Physician Decision
|
1
|
|
Titration Period
Withdrawal by Subject
|
10
|
|
Titration Period
Other: Not Lack of Analgesic Effect
|
8
|
|
Long-Term Treatment Period
Adverse Event
|
19
|
|
Long-Term Treatment Period
Lack of Efficacy
|
6
|
|
Long-Term Treatment Period
Lost to Follow-up
|
8
|
|
Long-Term Treatment Period
Withdrawal by Subject
|
19
|
|
Long-Term Treatment Period
Physician Decision
|
1
|
|
Long-Term Treatment Period
Other: Not Lack of Analgesic Effect
|
46
|
Baseline Characteristics
Longterm Safety Study of BEMA Buprenorphine in Subjects With Chronic Pain
Baseline characteristics by cohort
| Measure |
BEMA Buproneorphine Overall
n=302 Participants
buprenorphine buccal soluble film
BEMA Buprenorphine (All Doses): buccal soluble film; applied to the buccal mucosa twice daily
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
235 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
67 Participants
n=5 Participants
|
|
Age, Continuous
|
55.5 Years
STANDARD_DEVIATION 12.45 • n=5 Participants
|
|
Sex: Female, Male
Female
|
183 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
119 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
58 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
237 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Weight (kg)
|
92.86 kilograms
STANDARD_DEVIATION 22.250 • n=5 Participants
|
|
Height (cm)
|
169.14 centimeters
STANDARD_DEVIATION 10.540 • n=5 Participants
|
|
BMI (kg/m^2)
|
32.226 kg/m^2
STANDARD_DEVIATION 6.8542 • n=5 Participants
|
|
NRS Pain Score
|
3.3 units on a scale
STANDARD_DEVIATION 1.94 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline up to approximately Week 52The NRS Pain intensity score is a segmented version of a visual analog scale used to measure pain. The scale is from 0 (no pain) to 10. Scores between greater than 0 and 3 are considered mild pain, scores from greater than 3 to 6 are moderate and greater than 6 to 10 are severe. The daily average is calculated and used to calculate the change from baseline at week 52.
Outcome measures
| Measure |
BEMA Buproneorphine Overall
n=127 Participants
buprenorphine buccal soluble film
BEMA Buprenorphine (All Doses): buccal soluble film; applied to the buccal mucosa twice daily
|
|---|---|
|
Change From Baseline in NRS Pain Intensity
|
-0.24 units on a scale
Standard Deviation 1.803
|
SECONDARY outcome
Timeframe: Baseline to Week 28Patient Global Impression of Change in Pain Intensity at Week 28 as measured by a 7 point scale. Patients measure their improvement from 7='very much improved', 6='much improved', 5='minimally improved', 4='no change', 3='minimally worse', 2='much worse', 1='very much worse'.
Outcome measures
| Measure |
BEMA Buproneorphine Overall
n=98 Participants
buprenorphine buccal soluble film
BEMA Buprenorphine (All Doses): buccal soluble film; applied to the buccal mucosa twice daily
|
|---|---|
|
Patient Global Impression of Change in Pain Intensity
|
5.5 units on a scale
Standard Deviation 1.31
|
SECONDARY outcome
Timeframe: Baseline to Week 28Treatment Satisfaction Questionnaire for Medication/Global Satisfaction at Week 28. Patients complete a 14 item questionaire that measures 4 scales based on side effects, effectiveness, convenience and global satisfaction. All items have either five or seven responses (except item 4), scored from one (least satisfied) to five or seven (most satisfied). The 7-item scales have a non-neutral midpoint, such that there are more positive response options than negative response options. Item scores are summed to give four domain scores, which are in turn transformed to a scale of 0-100. Item 4 was not included for scoring. If an item score is missing and half of the items in the domain are complete, domain scores may be imputed from the person-specific mean score of completed items
Outcome measures
| Measure |
BEMA Buproneorphine Overall
n=97 Participants
buprenorphine buccal soluble film
BEMA Buprenorphine (All Doses): buccal soluble film; applied to the buccal mucosa twice daily
|
|---|---|
|
Treatment Satisfaction Questionnaire for Medication/Global Satisfaction
|
76.6 units on a scale
Standard Deviation 15.93
|
SECONDARY outcome
Timeframe: Baseline to Week 52Subjects Overall Satisfaction with Study Drug as measured on a 5 point scale, with 1 being not satisfied and 5 being very satisified.
Outcome measures
| Measure |
BEMA Buproneorphine Overall
n=122 Participants
buprenorphine buccal soluble film
BEMA Buprenorphine (All Doses): buccal soluble film; applied to the buccal mucosa twice daily
|
|---|---|
|
Subjects Overall Satisfaction With Study Drug
|
4.1 units on a scale
Standard Deviation 0.80
|
SECONDARY outcome
Timeframe: Baseline to Week 52Investigator's Overall Satisfaction with Study Drug measured on a 5-point scale, with 1 being not satisfied and 5 being very satisfied.
Outcome measures
| Measure |
BEMA Buproneorphine Overall
n=122 Participants
buprenorphine buccal soluble film
BEMA Buprenorphine (All Doses): buccal soluble film; applied to the buccal mucosa twice daily
|
|---|---|
|
Investigator's Overall Satisfaction With Study Drug
|
4.2 units on a scale
Standard Deviation 0.78
|
Adverse Events
BEMA Buproneorphine Overall
Serious events: 4 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BEMA Buproneorphine Overall
n=302 participants at risk
buprenorphine buccal soluble film
BEMA Buprenorphine (All Doses): buccal soluble film; applied to the buccal mucosa twice daily
|
|---|---|
|
Cardiac disorders
Arrhythmia
|
0.33%
1/302 • Number of events 1 • 52 Weeks
Adverse Events that are considered treatment-emergent that occurred during the titration period.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.33%
1/302 • Number of events 1 • 52 Weeks
Adverse Events that are considered treatment-emergent that occurred during the titration period.
|
|
General disorders
Oedema
|
0.33%
1/302 • Number of events 1 • 52 Weeks
Adverse Events that are considered treatment-emergent that occurred during the titration period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
0.33%
1/302 • Number of events 1 • 52 Weeks
Adverse Events that are considered treatment-emergent that occurred during the titration period.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.33%
1/302 • Number of events 1 • 52 Weeks
Adverse Events that are considered treatment-emergent that occurred during the titration period.
|
Other adverse events
| Measure |
BEMA Buproneorphine Overall
n=302 participants at risk
buprenorphine buccal soluble film
BEMA Buprenorphine (All Doses): buccal soluble film; applied to the buccal mucosa twice daily
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
3.0%
9/302 • Number of events 9 • 52 Weeks
Adverse Events that are considered treatment-emergent that occurred during the titration period.
|
|
Cardiac disorders
Arrhythmia
|
0.33%
1/302 • Number of events 1 • 52 Weeks
Adverse Events that are considered treatment-emergent that occurred during the titration period.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.33%
1/302 • Number of events 1 • 52 Weeks
Adverse Events that are considered treatment-emergent that occurred during the titration period.
|
|
Gastrointestinal disorders
Constipation
|
0.66%
2/302 • Number of events 2 • 52 Weeks
Adverse Events that are considered treatment-emergent that occurred during the titration period.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.33%
1/302 • Number of events 1 • 52 Weeks
Adverse Events that are considered treatment-emergent that occurred during the titration period.
|
|
Gastrointestinal disorders
Flatulence
|
0.33%
1/302 • Number of events 1 • 52 Weeks
Adverse Events that are considered treatment-emergent that occurred during the titration period.
|
|
Gastrointestinal disorders
Vomiting
|
0.33%
1/302 • Number of events 1 • 52 Weeks
Adverse Events that are considered treatment-emergent that occurred during the titration period.
|
|
General disorders
Fatigue
|
1.7%
5/302 • Number of events 5 • 52 Weeks
Adverse Events that are considered treatment-emergent that occurred during the titration period.
|
|
General disorders
Irritability
|
0.66%
2/302 • Number of events 2 • 52 Weeks
Adverse Events that are considered treatment-emergent that occurred during the titration period.
|
|
Infections and infestations
Wound Infection Staphylococcal
|
0.33%
1/302 • Number of events 1 • 52 Weeks
Adverse Events that are considered treatment-emergent that occurred during the titration period.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.33%
1/302 • Number of events 1 • 52 Weeks
Adverse Events that are considered treatment-emergent that occurred during the titration period.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.33%
1/302 • Number of events 1 • 52 Weeks
Adverse Events that are considered treatment-emergent that occurred during the titration period.
|
|
Metabolism and nutrition disorders
Gout
|
0.33%
1/302 • Number of events 1 • 52 Weeks
Adverse Events that are considered treatment-emergent that occurred during the titration period.
|
|
Musculoskeletal and connective tissue disorders
Epicondylitis
|
0.33%
1/302 • Number of events 1 • 52 Weeks
Adverse Events that are considered treatment-emergent that occurred during the titration period.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.33%
1/302 • Number of events 1 • 52 Weeks
Adverse Events that are considered treatment-emergent that occurred during the titration period.
|
|
Nervous system disorders
Balance Disorder
|
0.33%
1/302 • Number of events 1 • 52 Weeks
Adverse Events that are considered treatment-emergent that occurred during the titration period.
|
|
Nervous system disorders
Cognitive Disorder
|
0.33%
1/302 • Number of events 1 • 52 Weeks
Adverse Events that are considered treatment-emergent that occurred during the titration period.
|
|
Nervous system disorders
Dizziness
|
0.99%
3/302 • Number of events 3 • 52 Weeks
Adverse Events that are considered treatment-emergent that occurred during the titration period.
|
|
Nervous system disorders
Headache
|
0.66%
2/302 • Number of events 2 • 52 Weeks
Adverse Events that are considered treatment-emergent that occurred during the titration period.
|
|
Nervous system disorders
Hypoaesthesia
|
0.33%
1/302 • Number of events 1 • 52 Weeks
Adverse Events that are considered treatment-emergent that occurred during the titration period.
|
|
Nervous system disorders
Somnolence
|
0.33%
1/302 • Number of events 1 • 52 Weeks
Adverse Events that are considered treatment-emergent that occurred during the titration period.
|
|
Psychiatric disorders
Anxiety
|
0.66%
2/302 • Number of events 2 • 52 Weeks
Adverse Events that are considered treatment-emergent that occurred during the titration period.
|
|
Psychiatric disorders
Depression
|
0.33%
1/302 • Number of events 1 • 52 Weeks
Adverse Events that are considered treatment-emergent that occurred during the titration period.
|
|
Psychiatric disorders
Insomnia
|
0.33%
1/302 • Number of events 1 • 52 Weeks
Adverse Events that are considered treatment-emergent that occurred during the titration period.
|
|
Psychiatric disorders
Somnolence
|
0.33%
1/302 • Number of events 1 • 52 Weeks
Adverse Events that are considered treatment-emergent that occurred during the titration period.
|
|
Psychiatric disorders
Suicidal Ideation
|
0.33%
1/302 • Number of events 1 • 52 Weeks
Adverse Events that are considered treatment-emergent that occurred during the titration period.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.33%
1/302 • Number of events 1 • 52 Weeks
Adverse Events that are considered treatment-emergent that occurred during the titration period.
|
|
Skin and subcutaneous tissue disorders
Hypoaesthesia Facial
|
0.33%
1/302 • Number of events 1 • 52 Weeks
Adverse Events that are considered treatment-emergent that occurred during the titration period.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.33%
1/302 • Number of events 1 • 52 Weeks
Adverse Events that are considered treatment-emergent that occurred during the titration period.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.33%
1/302 • Number of events 1 • 52 Weeks
Adverse Events that are considered treatment-emergent that occurred during the titration period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place