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| Name | Class |
|---|---|
| Mundipharma Korea Ltd | INDUSTRY |
| Mundipharma (Hong Kong) Ltd | UNKNOWN |
| Mundipharma Distribution GmBH (Philippine Branch) | UNKNOWN |
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The purpose of this study is to assess the efficacy of the buprenorphine transdermal patch (Norspan® or Sovenor® transdermal patch) in patients with chronic non-malignant pain of moderate to severe intensity due to osteoarthritis, rheumatoid arthritis, lower back pain and joint/muscle pain, who are not adequately responding to non-opioid painkillers.
Baseline assessment (Visit 1) includes medical history, physical examination, vital signs.
At Visit 2 [7 days ( ± 3 days) after Visit 1] and subsequent optional titration visits up to (Visit 1 + 42 days) , patients will be titrated up to an effective and tolerated dose of Norspan® or Sovenor® transdermal patch and continue rescue analgesic, if necessary.
Titration period is dependent on time to achieving optimal pain control as determined by the investigator. The up-titration regime is planned on a weekly basis. Earlier dose titration (i.e. minimum 3 days after the patch application) is permitted at the investigator's discretion if the pain is uncontrolled. Effective and tolerated dose is assessed by data recorded in the case report form and patient diary.
According to country label, all patients will begin treatment with Norspan® or Sovenor® transdermal patch 5mg and will then be up-titrated, if necessary, to a maximum of Norspan® or Sovenor® transdermal patch 40mg or according to country label to achieve stable pain control. Patients that require oral opioid at any time during the study should be discontinued from the trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Buprenorphine transdermal patch | Experimental | Subjects will be on either 5mg, 10mg, 15mg, 20mg, 25mg, 30mg or 40mg doses for 17 weeks. Dose titration will occur every week for the first 6 weeks, and will be maintained for the next 11 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Buprenorphine transdermal patch | Drug | Please see Arm Description. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy According to BS-11 Pain Score Reduction | The primary efficacy outcome analysis is the pre- and post-intervention change in BS-11 pain score. The reduction in scores were calculated by subtracting the post-intervention score from the baseline score. BS-11 is known as "Box scale-11"; it 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. | Maximum 17 weeks starting from enrolment |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Efficacy Outcome Determined by Change in Percentage of Subjects Who Met Criteria on EQ5D-3L Quality of Life Questionnaire From Pre- to Post-intervention | Pre-intervention: Visit 1 Post-intervention: Visit 6 There are 5 dimensions in the EQ5D-3L questionnaire answered by the subjects, classified into 5 categories here: Mobility -- change in % of subjects who have no problem in walking around Self-care -- change in % of subjects who have no problem in self-care Usual activities -- change in % of subjects who have no problem with performing their usual activities Pain/ discomfort -- change in % of subjects who do not experience pain or discomfort Anxiety/ depression -- change in % of subjects who do not feel anxious or depressed |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pok Oi Hospital | Yuen Long | New Territories | Hong Kong | |||
| Queen Elizabeth Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28778219 | Derived | Yoon DH, Bin SI, Chan SK, Chung CK, In Y, Kim H, Lichauco JJ, Mok CC, Moon YW, Ng TK, Penserga EG, Shin DA, You D, Moon H. Effectiveness and tolerability of transdermal buprenorphine patches: a multicenter, prospective, open-label study in Asian patients with moderate to severe chronic musculoskeletal pain. BMC Musculoskelet Disord. 2017 Aug 4;18(1):337. doi: 10.1186/s12891-017-1664-4. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Buprenorphine Transdermal Patch | Subjects will be on either 5mg, 10mg, 15mg, 20mg, 25mg, 30mg or 40mg doses for 17 weeks. Dose titration will occur every week for the first 6 weeks, and will be maintained for the next 11 weeks. Buprenorphine transdermal patch: Please see Arm Description. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| approximately 17 weeks starting from enrolment |
| Treatment-emergent Adverse Events (TEAE's) as Measured by Number of Subjects With at Least 1 TEAE | Side effects of the transdermal patch treatment will be analysed. | From time of enrolment up to 7 days after completion / discontinuation visit (up to 140 days) |
| Secondary Efficacy Outcome as Measured by Number of Subjects Requiring at Least 1 Breakthrough (Rescue) Pain Medication | Daily use of breakthrough pain medication from visits 1-6, assessed from patient diaries. | Approximately 17 weeks starting from enrolment |
| Secondary Efficacy Outcome on Physicians' and Patients' Treatment Satisfaction Assessed Using Physician's Global Impression of Change Scale and Patient's Global Impression of Change Scale Respectively | 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" | At visit 6 (anywhere between Day 91 to 119 after enrolment depending on how long titration took) |
| Secondary Efficacy Outcome -- Incidence of Early Treatment Discontinuation Due to Lack of Efficacy. | From time of enrolment to Visit 6 (ie. up to119 days from enrolment) |
| Gascoigne Road |
| Hong Kong |
| Queen Mary Hospital (Dept of Anaesthesiology) | Pokfulam Road | Hong Kong |
| Queen Mary Hospital (Dept of Rheumatology) | Pokfulam Road | Hong Kong |
| Prince of Wales Hospital | Shatin | Hong Kong |
| Tuen Mun Hospital | Tuenmen | Hong Kong |
| Makati Medical Center | Makati City | Philippines |
| Philippine General Hospital | Manila | Philippines |
| University of Santo Tomas Hospital | Manila | Philippines |
| St. Luke's Medical Center | Quezon City | Philippines |
| Samsung Medical Center | Gangnam-Gu | Seoul | 135710 | South Korea |
| Seoul National University Hospital (Dept of Neurology) | Jongno-gu | Seoul | 110744 | South Korea |
| Seoul National University Hospital (Dept of Orthopedics) | Jongno-gu | Seoul | 110744 | South Korea |
| Seoul St. Mary's Hospital | Seocho-gu | Seoul | 137701 | South Korea |
| Severance Hospital | Seodaemun-gu | Seoul | 120752 | South Korea |
| Asan Medical Center | Songpa-Gu | Seoul | 138736 | South Korea |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Buprenorphine Transdermal Patch | Subjects will be on either 5mg, 10mg, 15mg, 20mg, 25mg, 30mg or 40mg doses for 17 weeks. Dose titration will occur every week for the first 6 weeks, and will be maintained for the next 11 weeks. Buprenorphine transdermal patch: Please see Arm Description. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Efficacy According to BS-11 Pain Score Reduction | The primary efficacy outcome analysis is the pre- and post-intervention change in BS-11 pain score. The reduction in scores were calculated by subtracting the post-intervention score from the baseline score. BS-11 is known as "Box scale-11"; it 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. | Subjects of the analysis population met the eligibility criteria. It consists of subjects who completed the study and who withdrew for any reason. | Posted | Mean | Standard Deviation | units on a scale | Maximum 17 weeks starting from enrolment |
|
|
| |||||||||||||||||||||||||
| Secondary | Secondary Efficacy Outcome Determined by Change in Percentage of Subjects Who Met Criteria on EQ5D-3L Quality of Life Questionnaire From Pre- to Post-intervention | Pre-intervention: Visit 1 Post-intervention: Visit 6 There are 5 dimensions in the EQ5D-3L questionnaire answered by the subjects, classified into 5 categories here: Mobility -- change in % of subjects who have no problem in walking around Self-care -- change in % of subjects who have no problem in self-care Usual activities -- change in % of subjects who have no problem with performing their usual activities Pain/ discomfort -- change in % of subjects who do not experience pain or discomfort Anxiety/ depression -- change in % of subjects who do not feel anxious or depressed | Posted | Number | percentage of subjects | approximately 17 weeks starting from enrolment |
|
| ||||||||||||||||||||||||||||
| Secondary | Treatment-emergent Adverse Events (TEAE's) as Measured by Number of Subjects With at Least 1 TEAE | Side effects of the transdermal patch treatment will be analysed. | Posted | Number | participants | From time of enrolment up to 7 days after completion / discontinuation visit (up to 140 days) |
|
| ||||||||||||||||||||||||||||
| Secondary | Secondary Efficacy Outcome as Measured by Number of Subjects Requiring at Least 1 Breakthrough (Rescue) Pain Medication | Daily use of breakthrough pain medication from visits 1-6, assessed from patient diaries. | Posted | Number | participants | Approximately 17 weeks starting from enrolment |
|
| ||||||||||||||||||||||||||||
| Secondary | Secondary Efficacy Outcome on Physicians' and Patients' Treatment Satisfaction Assessed Using Physician's Global Impression of Change Scale and Patient's Global Impression of Change Scale Respectively | 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" | Posted | Mean | Standard Deviation | units on a scale | At visit 6 (anywhere between Day 91 to 119 after enrolment depending on how long titration took) |
|
| |||||||||||||||||||||||||||
| Secondary | Secondary Efficacy Outcome -- Incidence of Early Treatment Discontinuation Due to Lack of Efficacy. | Posted | Number | participants | From time of enrolment to Visit 6 (ie. up to119 days from enrolment) |
|
|
The timeframe is up to 140 days. All adverse events will be recorded from the time the ICF is signed until 7 days after the completion/ discontinuation visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Buprenorphine Transdermal Patch | Subjects will be on either 5mg, 10mg, 15mg, 20mg, 25mg, 30mg or 40mg doses for 17 weeks. Dose titration will occur every week for the first 6 weeks, and will be maintained for the next 11 weeks. Buprenorphine transdermal patch: Please see Arm Description. | 1 | 114 | 89 | 114 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertensive Crisis | Cardiac disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Tachycardia | Cardiac disorders |
| |||
| Tinnitus | Ear and labyrinth disorders |
| |||
| Vertigo | Ear and labyrinth disorders |
| |||
| Abdominal Discomfort | Gastrointestinal disorders |
| |||
| Abdominal Pain | Gastrointestinal disorders |
| |||
| Constipation | Gastrointestinal disorders |
| |||
| Diarrhea | Gastrointestinal disorders |
| |||
| Dry Mouth | Gastrointestinal disorders |
| |||
| Dyspepsia | Gastrointestinal disorders |
| |||
| Enteritis | Gastrointestinal disorders |
| |||
| Eructation | Gastrointestinal disorders |
| |||
| Flatulence | Gastrointestinal disorders |
| |||
| Gingival Ulceration | Gastrointestinal disorders |
| |||
| Nausea | Gastrointestinal disorders |
| |||
| Periodontitis | Gastrointestinal disorders |
| |||
| Toothache | Gastrointestinal disorders |
| |||
| Vomiting | Gastrointestinal disorders |
| |||
| Application Site Erythema | General disorders |
| |||
| Application Site Irritation | General disorders |
| |||
| Application Site Pruritus | General disorders |
| |||
| Application Site Rash | General disorders |
| |||
| Application Site Swelling | General disorders |
| |||
| Application Site Warmth | General disorders |
| |||
| Asthenia | General disorders |
| |||
| Chest Discomfort | General disorders |
| |||
| Chest Pain | General disorders |
| |||
| Fatigue | General disorders |
| |||
| Feeling Cold | General disorders |
| |||
| Influenza-like Illness | General disorders |
| |||
| Edema | General disorders |
| |||
| Pyrexia | General disorders |
| |||
| Allergy to Arthropod Sting | Immune system disorders |
| |||
| Acute Tonsillitis | Infections and infestations |
| |||
| Nasopharyngitis | Infections and infestations |
| |||
| Paronychia | Infections and infestations |
| |||
| Rhinitis | Infections and infestations |
| |||
| Upper Respiratory Tract Infection | Infections and infestations |
| |||
| Vaginal Infection | Infections and infestations |
| |||
| Excoriation | Injury, poisoning and procedural complications |
| |||
| Muscle Injury | Injury, poisoning and procedural complications |
| |||
| Muscle Strain | Injury, poisoning and procedural complications |
| |||
| Alanine Aminotransferase Increased | Investigations |
| |||
| Decreased Appetite | Metabolism and nutrition disorders |
| |||
| Arthralgia | Musculoskeletal and connective tissue disorders |
| |||
| Back Pain | Musculoskeletal and connective tissue disorders |
| |||
| Joint Effusion | Musculoskeletal and connective tissue disorders |
| |||
| Joint Swelling | Musculoskeletal and connective tissue disorders |
| |||
| Muscular Weakness | Musculoskeletal and connective tissue disorders |
| |||
| Pain In Extremity | Musculoskeletal and connective tissue disorders |
| |||
| Synovial cyst | Musculoskeletal and connective tissue disorders |
| |||
| Dizziness | Nervous system disorders |
| |||
| Headache | Nervous system disorders |
| |||
| Hypoesthesia | Nervous system disorders |
| |||
| Somnolence | Nervous system disorders |
| |||
| Insomnia | Psychiatric disorders |
| |||
| Dysuria | Renal and urinary disorders |
| |||
| Urinary Hesitation | Renal and urinary disorders |
| |||
| Bronchiectasis | Respiratory, thoracic and mediastinal disorders |
| |||
| Cough | Respiratory, thoracic and mediastinal disorders |
| |||
| Dyspnea | Respiratory, thoracic and mediastinal disorders |
| |||
| Cold Sweat | Skin and subcutaneous tissue disorders |
| |||
| Dermatitis Allergic | Skin and subcutaneous tissue disorders |
| |||
| Erythema | Skin and subcutaneous tissue disorders |
| |||
| Hyperhidrosis | Skin and subcutaneous tissue disorders |
| |||
| Pruritus | Skin and subcutaneous tissue disorders |
| |||
| Rash | Skin and subcutaneous tissue disorders |
| |||
| Urticaria | Skin and subcutaneous tissue disorders |
| |||
| Hypertensive Crisis | Vascular disorders |
|
Data emerging from the study cannot be released without the permission of the sponsor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Valerie Anne Leck | Mundipharma Pte Ltd | +65 6511 1165 | info.rma@mundipharma.com.sg |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001172 | Arthritis, Rheumatoid |
| D017116 | Low Back Pain |
| D018771 | Arthralgia |
| D063806 | Myalgia |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009135 | Muscular Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D059352 | Musculoskeletal Pain |
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| Korea, Republic of |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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