SOOTHE: Safety and Effectiveness of Transdermal Buprenorphine in Cancer Pain
Study Details
Study Description
Brief Summary
Buprenorphine transdermal patch is newly available in Taiwan in June 2017, the trade name is Transtec, and the available dosages are 35 μg/h and 52.5 μg/h. Taiwan is the first Asia country which launched Transtec for cancer pain treatment. Although the efficacy of transdermal buprenorphine has been demonstrated in some randomized, placebo-controlled studies and also conducted a large scale post-marketing surveillance study in Germany, therefore the local scientific data is required for Asia experience. Due to above rationale, this observational study will be initiated in Taiwan, to build up the first real-world scientific data in Asia.
The objective of this study is to collect the safety and effectiveness of transdermal buprenorphine in routine clinical practice, in particular, to collect data in population with controlled cancer pain and stable titration from previous opioid analgesics in Taiwan.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
The objective of this observational study is to collect effectiveness and safety data on the labelled use of buprenorphine transdermal patches (Transtec 35 μg/h and 52.5 μg/h) under regular and routine clinical conditions in Taiwan for cancer patients with moderate to severe cancer pain (NRS Score>=4) and strong opioids are needed for their pain treatment.
Study Design
Outcome Measures
Primary Outcome Measures
- Adverse drug reaction [Week 3 to Week 4 or early termination]
Number and percentage of patients with adverse drug reactions and serious adverse drug reactions
Secondary Outcome Measures
- Pain intensity and interference [whole study-1 month]
Pain intensity and interference measured by the Brief Pain Inventory (BPI)
- Daily pain intensity measured by a numerical rating scale (NRS) by patients [1 month]
Daily pain intensity measured by a numerical rating scale (NRS) designed in a patient diary card
- Quality of life of the patients [1 month]
Quality of life measured by the EORTC QLQ-C30
- Quality of sleep of the patients [1 month]
Quality of sleep measured by a NRS
- Number of breakthrough pain [1 month]
Number of breakthrough pain during the observational period
- Treatment discontinuation and associated reasons [during study period-1 month]
reason for stop treatments
Other Outcome Measures
- ECG changes [1 month of study period]
The change from baseline in ECG measurement at each visit
Eligibility Criteria
Criteria
Inclusion Criteria:
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Cancer patients aged 20 years old and over
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ECOG <3
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Moderate or severe pain intensity with stable titration from previous opioid analgesics, 7 days at least prior to enrolment and with the dose equivalent to oral morphine ranging from 60 to 120 mg/day in previous treatment
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Cancer-related pain that requires treatment with continuous around-the-clock strong opioid analgesic
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Patients who are going to start Transtec treatment per clinical judgment, according to the locally approved labeling, are eligible.
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Patients who are able to communicate and fill out the questionnaire forms
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Patient provided signed informed consent
Exclusion Criteria:
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Patients diagnosed with non-cancer pain or unexplained pain
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Patients who have constipation (CTCAE grade 3 and above)
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Patients with uncontrolled or unstable cardiac disease
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Abnormal lab results, with obvious clinical significance, such as ALT or AST>= 3 fold of upper limit of normal value or liver function of Child C grade prior to study
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ALT or AST >= 5 fold of upper limit of normal value for patients with liver metastasis or primary liver cancer
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Pregnant or nursing (lactating) women
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Patients who are drug or alcohol abuse
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Patients who have hypersensitivity to buprenorphine
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Patients who are clinically unstable or have a life expectancy of less than 8 weeks making completion of the trial unlikely
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With any contraindications or using prohibited medication per locally approved
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Chang Gung Memorial Hospital- Linko Branch | New Taipei City | Taiwan |
Sponsors and Collaborators
- Taiwan Mundipharma Pharmaceuticals Ltd.
- Chang Gung Memorial Hospital
- Changhua Christian Hospital
- Taipei Medical University Shuang Ho Hospital
Investigators
- Principal Investigator: Jen-Shi Chen, MD, Chang Gung Memorial Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BUP17-TW-401