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

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: NCT02519387
Recruitment Status : Completed
First Posted : August 10, 2015
Results First Posted : July 20, 2016
Last Update Posted : July 20, 2016
Sponsor:
Information provided by (Responsible Party):
Mundipharma Pharmaceuticals Sdn. Bhd.

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Osteoarthritis
Rheumatoid Arthritis
Lower Back Pain
Joint Pain
Muscle Pain
Intervention Drug: Buprenorphine Transdermal Patch
Enrollment 78
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Buprenorphine Transdermal Patch
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Buprenorphrine transdermal patch 5mg/10mg, every 7 days, for 3 months

Buprenorphine Transdermal Patch

Period Title: Overall Study
Started 78
Completed 56
Not Completed 22
Arm/Group Title Buprenorphine Transdermal Patch
Hide Arm/Group Description

Buprenorphrine transdermal patch 5mg/10mg, every 7 days, for 3 months

Buprenorphine Transdermal Patch

Overall Number of Baseline Participants 78
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[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 78 participants
61.9  (9.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 78 participants
Female
56
  71.8%
Male
22
  28.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Malaysia Number Analyzed 78 participants
78
1.Primary Outcome
Title Change in Box Scale-11 (BS-11) Pain Score
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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.

Time Frame Baseline,3 months
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Hide Analysis Population Description
These patients were eligible and included in the intent-to-treat efficacy population.
Arm/Group Title Buprenorphine Transdermal Patch
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Buprenorphrine transdermal patch 5mg/10mg, every 7 days, for 3 months

Buprenorphine Transdermal Patch

Overall Number of Participants Analyzed 78
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (Visit 1) 6.2  (1.8)
3 Months (Visit 6) 4.0  (2.3)
2.Secondary Outcome
Title Change in Sleep Quality as Determined by the 8-item Global Sleep Quality Assessment (GSQA)
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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
Time Frame Baseline, 3 months
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Buprenorphine Transdermal Patch
Hide Arm/Group Description:

Buprenorphrine transdermal patch 5mg/10mg, every 7 days, for 3 months

Buprenorphine Transdermal Patch

Overall Number of Participants Analyzed 78
Mean (Standard Deviation)
Unit of Measure: units on a scale
Trouble falling asleep due to pain (Baseline) 3.4  (2.9)
Trouble falling asleep due to pain (3 Months) 2.5  (2.9)
Need for pain medication to sleep (Baseline) 2.2  (2.9)
Need for pain medication to sleep (3 Months) 1.4  (2.5)
Need for sleep medication to sleep (Baseline) 0.3  (1.4)
Need for sleep medication to sleep (3 Months) 0.2  (1.2)
Awakened by pain at night (Baseline) 2.6  (2.8)
Awakened by pain at night (3 Months) 2.0  (2.6)
Awakened by pain in the morning (Baseline) 1.9  (2.5)
Awakened by pain in the morning (3 Months) 1.3  (2.3)
Pain affecting partner's sleep (Baseline) 1.2  (2.1)
Pain affecting partner's sleep (3 Months) 1.0  (2.0)
Rate own sleep quality (Baseline) 2.8  (0.8)
Rate own sleep quality (3 Months) 2.5  (0.8)
Average hours of sleep per night (Baseline) 5.7  (1.4)
Average hours of sleep per night (3 Months) 5.8  (1.4)
3.Secondary Outcome
Title Daily Use of Breakthrough Pain Medication as Measured by Number of Subjects With at Least 1 Day of Breakthrough (Rescue) Pain Medication Usage
Hide Description Patients will record any other pain medication used in a patient home diary
Time Frame 3 months
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Buprenorphine Transdermal Patch
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Buprenorphrine transdermal patch 5mg/10mg, every 7 days, for 3 months

Buprenorphine Transdermal Patch

Overall Number of Participants Analyzed 78
Measure Type: Number
Unit of Measure: participants
46
4.Secondary Outcome
Title 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
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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"

Time Frame 3 months
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Buprenorphine Transdermal Patch
Hide Arm/Group Description:

Buprenorphrine transdermal patch 5mg/10mg, every 7 days, for 3 months

Buprenorphine Transdermal Patch

Overall Number of Participants Analyzed 78
Mean (Standard Deviation)
Unit of Measure: units on a scale
Physician Impression 2.0  (0.7)
Patient Impression 2.3  (0.7)
5.Secondary Outcome
Title Tolerability of Buprenorphine Patch Determined by Number of Patients Who Withdrew From the Study Due to Adverse Events
Hide Description [Not Specified]
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
This is the intent-to-treat population.
Arm/Group Title Buprenorphine Transdermal Patch
Hide Arm/Group Description:

Buprenorphrine transdermal patch 5mg/10mg, every 7 days, for 3 months

Buprenorphine Transdermal Patch

Overall Number of Participants Analyzed 78
Measure Type: Number
Unit of Measure: participants
17
Time Frame Adverse event data were collected over a period of 3 months from the time a patient is enrolled.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Buprenorphine Transdermal Patch
Hide Arm/Group Description

Buprenorphrine transdermal patch 5mg/10mg, every 7 days, for 3 months

Buprenorphine Transdermal Patch

All-Cause Mortality
Buprenorphine Transdermal Patch
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Buprenorphine Transdermal Patch
Affected / at Risk (%) # Events
Total   1/78 (1.28%)    
Musculoskeletal and connective tissue disorders   
Elbow fracture due to fall [1]  1/78 (1.28%)  1
Failed elbow implant  1/78 (1.28%)  1
[1]
Hospitalisation
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Buprenorphine Transdermal Patch
Affected / at Risk (%) # Events
Total   56/78 (71.79%)    
Cardiac disorders   
Palpitation  2/78 (2.56%) 
Gastrointestinal disorders   
Abdominal pain upper  1/78 (1.28%) 
Constipation  14/78 (17.95%) 
Diarrhea  1/78 (1.28%) 
Dry mouth  1/78 (1.28%) 
Gastritis  1/78 (1.28%) 
Nausea  22/78 (28.21%) 
Vomiting  10/78 (12.82%) 
Dry throat  2/78 (2.56%) 
General disorders   
Discomfort  1/78 (1.28%) 
Drug intolerance  1/78 (1.28%) 
Fatigue  2/78 (2.56%) 
Myalgia  1/78 (1.28%) 
Pain  1/78 (1.28%) 
Pyrexia  4/78 (5.13%) 
Peripheral swelling  1/78 (1.28%) 
Immune system disorders   
Application site allergy  1/78 (1.28%) 
Metabolism and nutrition disorders   
Decreased appetite  2/78 (2.56%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  3/78 (3.85%) 
Back pain  3/78 (3.85%) 
Pain in extremity  1/78 (1.28%) 
Pain in jaw  1/78 (1.28%) 
Nervous system disorders   
Headache  3/78 (3.85%) 
Hypoesthesia  1/78 (1.28%) 
Dizziness  19/78 (24.36%) 
Somnolence  17/78 (21.79%) 
Psychiatric disorders   
Confusional state  1/78 (1.28%) 
Respiratory, thoracic and mediastinal disorders   
Chest discomfort  1/78 (1.28%) 
Dyspnea  1/78 (1.28%) 
Skin and subcutaneous tissue disorders   
Erythema  3/78 (3.85%) 
Pruritus  15/78 (19.23%) 
Dermatitis allergic  1/78 (1.28%) 
Rash  1/78 (1.28%) 
Vascular disorders   
Increased blood pressure  1/78 (1.28%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Data emerging from the study cannot be released by the PI without permission from the sponsor.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Elayne Chan
Organization: Mundipharma Pharmaceuticals Sdn Bhd
Phone: +60 122162170
EMail: Elayne.Chan@mundipharma.com.my
Layout table for additonal information
Responsible Party: Mundipharma Pharmaceuticals Sdn. Bhd.
ClinicalTrials.gov Identifier: NCT02519387    
Other Study ID Numbers: BUP11-MY-401
First Submitted: July 15, 2015
First Posted: August 10, 2015
Results First Submitted: May 15, 2016
Results First Posted: July 20, 2016
Last Update Posted: July 20, 2016