Trial Outcomes & Findings for Efficacy and Safety of Buprenorphine Transdermal Patch in Non-cancer Pain of Moderate Intensity (NCT NCT02519387)

NCT ID: NCT02519387

Last Updated: 2016-07-20

Results Overview

The BS-11 (Box score-11) pain score was the main efficacy outcome measured in this study. The scores at baseline (Visit 1) and Visit 6 (3 months from baseline visit) are reported. BS-11 is an 11-point scale measuring pain intensity. It ranges from 0 to 10, whereby 0 represents no pain and 10 represents the worst imaginable pain. Subjects selected a number based on the pain intensity they were feeling at that time.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 78 participants
• Primary outcome timeframe: Baseline,3 months
• Results posted on: 2016-07-20

Participant Flow

Participant milestones

Measure	Buprenorphine Transdermal Patch Buprenorphrine transdermal patch 5mg/10mg, every 7 days, for 3 months Buprenorphine Transdermal Patch
Overall Study STARTED	78
Overall Study COMPLETED	56
Overall Study NOT COMPLETED	22

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy and Safety of Buprenorphine Transdermal Patch in Non-cancer Pain of Moderate Intensity

Baseline characteristics by cohort

Measure	Buprenorphine Transdermal Patch n=78 Participants Buprenorphrine transdermal patch 5mg/10mg, every 7 days, for 3 months Buprenorphine Transdermal Patch
Age, Continuous	61.9 years STANDARD_DEVIATION 9.7 • n=5 Participants
Sex: Female, Male Female	56 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants
Region of Enrollment Malaysia	78 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline,3 months

Population: These patients were eligible and included in the intent-to-treat efficacy population.

The BS-11 (Box score-11) pain score was the main efficacy outcome measured in this study. The scores at baseline (Visit 1) and Visit 6 (3 months from baseline visit) are reported.

BS-11 is an 11-point scale measuring pain intensity. It ranges from 0 to 10, whereby 0 represents no pain and 10 represents the worst imaginable pain. Subjects selected a number based on the pain intensity they were feeling at that time.

Outcome measures

Measure	Buprenorphine Transdermal Patch n=78 Participants Buprenorphrine transdermal patch 5mg/10mg, every 7 days, for 3 months Buprenorphine Transdermal Patch
Change in Box Scale-11 (BS-11) Pain Score Baseline (Visit 1)	6.2 units on a scale Standard Deviation 1.8
Change in Box Scale-11 (BS-11) Pain Score 3 Months (Visit 6)	4.0 units on a scale Standard Deviation 2.3

SECONDARY outcome

Timeframe: Baseline, 3 months

Subjects will evaluate the degree of their sleep disturbance due to pain and improvement in quality of sleep using the GSQA questionnaire comprising of 8 questions, at baseline (Visit 1) and Visit 6 (3 months from baseline visit).

The scores at baseline and Visit 6 are calculated for the following 8 items with scores of:

1. Trouble falling asleep due to pain -- on a scale of 0 to 10 where 0 is never and 10 is always

2. Need for pain medication to sleep -- as above

3. Need for sleep medication to sleep -- as above

4. Awakened by pain at night -- as above

5. Awakened by pain in the morning -- as above

6. Pain affecting partner's sleep -- as above

7. Rate own sleep quality -- on a scale of 1 to 5 where 1 is very good and 5 is very poor

8. Number of hours of sleep per night in last 7 days

Outcome measures

Measure	Buprenorphine Transdermal Patch n=78 Participants Buprenorphrine transdermal patch 5mg/10mg, every 7 days, for 3 months Buprenorphine Transdermal Patch
Change in Sleep Quality as Determined by the 8-item Global Sleep Quality Assessment (GSQA) Trouble falling asleep due to pain (Baseline)	3.4 units on a scale Standard Deviation 2.9
Change in Sleep Quality as Determined by the 8-item Global Sleep Quality Assessment (GSQA) Trouble falling asleep due to pain (3 Months)	2.5 units on a scale Standard Deviation 2.9
Change in Sleep Quality as Determined by the 8-item Global Sleep Quality Assessment (GSQA) Need for pain medication to sleep (Baseline)	2.2 units on a scale Standard Deviation 2.9
Change in Sleep Quality as Determined by the 8-item Global Sleep Quality Assessment (GSQA) Need for pain medication to sleep (3 Months)	1.4 units on a scale Standard Deviation 2.5
Change in Sleep Quality as Determined by the 8-item Global Sleep Quality Assessment (GSQA) Need for sleep medication to sleep (Baseline)	0.3 units on a scale Standard Deviation 1.4
Change in Sleep Quality as Determined by the 8-item Global Sleep Quality Assessment (GSQA) Need for sleep medication to sleep (3 Months)	0.2 units on a scale Standard Deviation 1.2
Change in Sleep Quality as Determined by the 8-item Global Sleep Quality Assessment (GSQA) Awakened by pain at night (Baseline)	2.6 units on a scale Standard Deviation 2.8
Change in Sleep Quality as Determined by the 8-item Global Sleep Quality Assessment (GSQA) Awakened by pain at night (3 Months)	2.0 units on a scale Standard Deviation 2.6
Change in Sleep Quality as Determined by the 8-item Global Sleep Quality Assessment (GSQA) Awakened by pain in the morning (Baseline)	1.9 units on a scale Standard Deviation 2.5
Change in Sleep Quality as Determined by the 8-item Global Sleep Quality Assessment (GSQA) Awakened by pain in the morning (3 Months)	1.3 units on a scale Standard Deviation 2.3
Change in Sleep Quality as Determined by the 8-item Global Sleep Quality Assessment (GSQA) Pain affecting partner's sleep (Baseline)	1.2 units on a scale Standard Deviation 2.1
Change in Sleep Quality as Determined by the 8-item Global Sleep Quality Assessment (GSQA) Pain affecting partner's sleep (3 Months)	1.0 units on a scale Standard Deviation 2.0
Change in Sleep Quality as Determined by the 8-item Global Sleep Quality Assessment (GSQA) Rate own sleep quality (Baseline)	2.8 units on a scale Standard Deviation 0.8
Change in Sleep Quality as Determined by the 8-item Global Sleep Quality Assessment (GSQA) Rate own sleep quality (3 Months)	2.5 units on a scale Standard Deviation 0.8
Change in Sleep Quality as Determined by the 8-item Global Sleep Quality Assessment (GSQA) Average hours of sleep per night (Baseline)	5.7 units on a scale Standard Deviation 1.4
Change in Sleep Quality as Determined by the 8-item Global Sleep Quality Assessment (GSQA) Average hours of sleep per night (3 Months)	5.8 units on a scale Standard Deviation 1.4

SECONDARY outcome

Timeframe: 3 months

Patients will record any other pain medication used in a patient home diary

Outcome measures

Measure	Buprenorphine Transdermal Patch n=78 Participants Buprenorphrine transdermal patch 5mg/10mg, every 7 days, for 3 months Buprenorphine Transdermal Patch
Daily Use of Breakthrough Pain Medication as Measured by Number of Subjects With at Least 1 Day of Breakthrough (Rescue) Pain Medication Usage	46 participants

SECONDARY outcome

Timeframe: 3 months

The overall assessment of the change in pain intensity from baseline is measured at Visit 6.

Physician's Global Impression of Change scale: Investigator's opinion on a scale of 1 to 7 where 1 is "very much improved" and 7 is "very much worse" Patient's Global Impression of Change scale: Subject's opinion on a scale of 1 to 7 where 1 is "very much improved" and 7 is "very much worse"

Outcome measures

Measure	Buprenorphine Transdermal Patch n=78 Participants Buprenorphrine transdermal patch 5mg/10mg, every 7 days, for 3 months Buprenorphine Transdermal Patch
Physicians' and Patients' Treatment Satisfaction of Buprenorphine Patch Usage Assessed Using Physician's Global Impression of Change Scale and Patient's Global Impression of Change Scale Respectively Physician Impression	2.0 units on a scale Standard Deviation 0.7
Physicians' and Patients' Treatment Satisfaction of Buprenorphine Patch Usage Assessed Using Physician's Global Impression of Change Scale and Patient's Global Impression of Change Scale Respectively Patient Impression	2.3 units on a scale Standard Deviation 0.7

SECONDARY outcome

Timeframe: 3 months

Population: This is the intent-to-treat population.

Outcome measures

Measure	Buprenorphine Transdermal Patch n=78 Participants Buprenorphrine transdermal patch 5mg/10mg, every 7 days, for 3 months Buprenorphine Transdermal Patch
Tolerability of Buprenorphine Patch Determined by Number of Patients Who Withdrew From the Study Due to Adverse Events	17 participants

Adverse Events

Buprenorphine Transdermal Patch

Serious events: 1 serious events

Other events: 56 other events

Deaths: 0 deaths

Serious adverse events

Measure	Buprenorphine Transdermal Patch n=78 participants at risk Buprenorphrine transdermal patch 5mg/10mg, every 7 days, for 3 months Buprenorphine Transdermal Patch
Musculoskeletal and connective tissue disorders Elbow fracture due to fall	1.3% 1/78 • Number of events 1 • Adverse event data were collected over a period of 3 months from the time a patient is enrolled.
Musculoskeletal and connective tissue disorders Failed elbow implant	1.3% 1/78 • Number of events 1 • Adverse event data were collected over a period of 3 months from the time a patient is enrolled.

Other adverse events

Measure	Buprenorphine Transdermal Patch n=78 participants at risk Buprenorphrine transdermal patch 5mg/10mg, every 7 days, for 3 months Buprenorphine Transdermal Patch
Cardiac disorders Palpitation	2.6% 2/78 • Adverse event data were collected over a period of 3 months from the time a patient is enrolled.
Gastrointestinal disorders Abdominal pain upper	1.3% 1/78 • Adverse event data were collected over a period of 3 months from the time a patient is enrolled.
Gastrointestinal disorders Constipation	17.9% 14/78 • Adverse event data were collected over a period of 3 months from the time a patient is enrolled.
Gastrointestinal disorders Diarrhea	1.3% 1/78 • Adverse event data were collected over a period of 3 months from the time a patient is enrolled.
Gastrointestinal disorders Dry mouth	1.3% 1/78 • Adverse event data were collected over a period of 3 months from the time a patient is enrolled.
Gastrointestinal disorders Gastritis	1.3% 1/78 • Adverse event data were collected over a period of 3 months from the time a patient is enrolled.
Gastrointestinal disorders Nausea	28.2% 22/78 • Adverse event data were collected over a period of 3 months from the time a patient is enrolled.
Gastrointestinal disorders Vomiting	12.8% 10/78 • Adverse event data were collected over a period of 3 months from the time a patient is enrolled.
Gastrointestinal disorders Dry throat	2.6% 2/78 • Adverse event data were collected over a period of 3 months from the time a patient is enrolled.
General disorders Discomfort	1.3% 1/78 • Adverse event data were collected over a period of 3 months from the time a patient is enrolled.
General disorders Drug intolerance	1.3% 1/78 • Adverse event data were collected over a period of 3 months from the time a patient is enrolled.
General disorders Fatigue	2.6% 2/78 • Adverse event data were collected over a period of 3 months from the time a patient is enrolled.
General disorders Myalgia	1.3% 1/78 • Adverse event data were collected over a period of 3 months from the time a patient is enrolled.
General disorders Pain	1.3% 1/78 • Adverse event data were collected over a period of 3 months from the time a patient is enrolled.
General disorders Pyrexia	5.1% 4/78 • Adverse event data were collected over a period of 3 months from the time a patient is enrolled.
General disorders Peripheral swelling	1.3% 1/78 • Adverse event data were collected over a period of 3 months from the time a patient is enrolled.
Immune system disorders Application site allergy	1.3% 1/78 • Adverse event data were collected over a period of 3 months from the time a patient is enrolled.
Metabolism and nutrition disorders Decreased appetite	2.6% 2/78 • Adverse event data were collected over a period of 3 months from the time a patient is enrolled.
Musculoskeletal and connective tissue disorders Arthralgia	3.8% 3/78 • Adverse event data were collected over a period of 3 months from the time a patient is enrolled.
Musculoskeletal and connective tissue disorders Back pain	3.8% 3/78 • Adverse event data were collected over a period of 3 months from the time a patient is enrolled.
Musculoskeletal and connective tissue disorders Pain in extremity	1.3% 1/78 • Adverse event data were collected over a period of 3 months from the time a patient is enrolled.
Musculoskeletal and connective tissue disorders Pain in jaw	1.3% 1/78 • Adverse event data were collected over a period of 3 months from the time a patient is enrolled.
Nervous system disorders Headache	3.8% 3/78 • Adverse event data were collected over a period of 3 months from the time a patient is enrolled.
Nervous system disorders Hypoesthesia	1.3% 1/78 • Adverse event data were collected over a period of 3 months from the time a patient is enrolled.
Nervous system disorders Dizziness	24.4% 19/78 • Adverse event data were collected over a period of 3 months from the time a patient is enrolled.
Nervous system disorders Somnolence	21.8% 17/78 • Adverse event data were collected over a period of 3 months from the time a patient is enrolled.
Psychiatric disorders Confusional state	1.3% 1/78 • Adverse event data were collected over a period of 3 months from the time a patient is enrolled.
Respiratory, thoracic and mediastinal disorders Chest discomfort	1.3% 1/78 • Adverse event data were collected over a period of 3 months from the time a patient is enrolled.
Respiratory, thoracic and mediastinal disorders Dyspnea	1.3% 1/78 • Adverse event data were collected over a period of 3 months from the time a patient is enrolled.
Skin and subcutaneous tissue disorders Erythema	3.8% 3/78 • Adverse event data were collected over a period of 3 months from the time a patient is enrolled.
Skin and subcutaneous tissue disorders Pruritus	19.2% 15/78 • Adverse event data were collected over a period of 3 months from the time a patient is enrolled.
Skin and subcutaneous tissue disorders Dermatitis allergic	1.3% 1/78 • Adverse event data were collected over a period of 3 months from the time a patient is enrolled.
Skin and subcutaneous tissue disorders Rash	1.3% 1/78 • Adverse event data were collected over a period of 3 months from the time a patient is enrolled.
Vascular disorders Increased blood pressure	1.3% 1/78 • Adverse event data were collected over a period of 3 months from the time a patient is enrolled.

Additional Information

Elayne Chan

Mundipharma Pharmaceuticals Sdn Bhd

Phone: +60 122162170

Email: Elayne.Chan@mundipharma.com.my

Results disclosure agreements

• Principal investigator is a sponsor employee Data emerging from the study cannot be released by the PI without permission from the sponsor.
• Publication restrictions are in place

Restriction type: OTHER