Safety and Effectiveness of Transdermal Buprenorphine in Cancer Pain

Cancer Clinical Trial

— SOOTHE  

Official title:

Safety and Effectiveness of Transdermal Buprenorphine in Cancer Pain: an Observational Study (SOOTHE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04315831
• Other study ID #: BUP17-TW-401
• Status: Completed
• Start date: January 31, 2018
• Est. completion date: March 31, 2019

Study information

• Verified date: March 2020
• Source: Taiwan Mundipharma Pharmaceuticals Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: March 31, 2019
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

1. Cancer patients aged 20 years old and over

2. ECOG <3

3. 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

4. Cancer-related pain that requires treatment with continuous around-the-clock strong opioid analgesic

5. Patients who are going to start Transtec treatment per clinical judgment, according to the locally approved labeling, are eligible.

6. Patients who are able to communicate and fill out the questionnaire forms

7. Patient provided signed informed consent

Exclusion Criteria:

1. Patients diagnosed with non-cancer pain or unexplained pain

2. Patients who have constipation (CTCAE grade 3 and above)

3. Patients with uncontrolled or unstable cardiac disease

4. 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

5. ALT or AST >= 5 fold of upper limit of normal value for patients with liver metastasis or primary liver cancer

6. Pregnant or nursing (lactating) women

7. Patients who are drug or alcohol abuse

8. Patients who have hypersensitivity to buprenorphine

9. Patients who are clinically unstable or have a life expectancy of less than 8 weeks making completion of the trial unlikely

10. With any contraindications or using prohibited medication per locally approved

Related Conditions & MeSH terms

• Cancer
• Cancer Pain

Intervention

Drug:
• Transdermal Buprenorphine
Intervention will be applied for patients with moderate to severe cancer pain

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital- Linko Branch	New Taipei City

Sponsors (4)

Lead Sponsor	Collaborator
Taiwan Mundipharma Pharmaceuticals Ltd.	Chang Gung Memorial Hospital, Changhua Christian Hospital, Taipei Medical University Shuang Ho Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	ECG changes	The change from baseline in ECG measurement at each visit	1 month of study period
Primary	Adverse drug reaction	Number and percentage of patients with adverse drug reactions and serious adverse drug reactions	Week 3 to Week 4 or early termination
Secondary	Pain intensity and interference	Pain intensity and interference measured by the Brief Pain Inventory (BPI)	whole study-1 month
Secondary	Daily pain intensity measured by a numerical rating scale (NRS) by patients	Daily pain intensity measured by a numerical rating scale (NRS) designed in a patient diary card	1 month
Secondary	Quality of life of the patients	Quality of life measured by the EORTC QLQ-C30	1 month
Secondary	Quality of sleep of the patients	Quality of sleep measured by a NRS	1 month
Secondary	Number of breakthrough pain	Number of breakthrough pain during the observational period	1 month
Secondary	Treatment discontinuation and associated reasons	reason for stop treatments	during study period-1 month