Trials / Completed
CompletedNCT04315831
Safety and Effectiveness of Transdermal Buprenorphine in Cancer Pain
Safety and Effectiveness of Transdermal Buprenorphine in Cancer Pain: an Observational Study (SOOTHE)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 83 (actual)
- Sponsor
- Taiwan Mundipharma Pharmaceuticals Ltd. · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Transdermal Buprenorphine | Intervention will be applied for patients with moderate to severe cancer pain |
Timeline
- Start date
- 2018-01-31
- Primary completion
- 2019-03-31
- Completion
- 2019-03-31
- First posted
- 2020-03-20
- Last updated
- 2020-03-20
Locations
1 site across 1 country: Taiwan
Source: ClinicalTrials.gov record NCT04315831. Inclusion in this directory is not an endorsement.