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Safety and Effectiveness of Transdermal Buprenorphine in Cancer Pain (SOOTHE)

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: NCT04315831
Recruitment Status : Completed
First Posted : March 20, 2020
Last Update Posted : March 20, 2020
Sponsor:
Collaborators:
Chang Gung Memorial Hospital
Changhua Christian Hospital
Taipei Medical University Shuang Ho Hospital
Information provided by (Responsible Party):
Taiwan Mundipharma Pharmaceuticals Ltd.

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
Cancer Drug: Transdermal Buprenorphine

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.

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Study Type : Observational
Actual Enrollment : 83 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Safety and Effectiveness of Transdermal Buprenorphine in Cancer Pain: an Observational Study (SOOTHE)
Actual Study Start Date : January 31, 2018
Actual Primary Completion Date : March 31, 2019
Actual Study Completion Date : March 31, 2019

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: Transdermal Buprenorphine
    Intervention will be applied for patients with moderate to severe cancer pain
    Other Name: no other intervention


Primary Outcome Measures :
  1. Adverse drug reaction [ Time Frame: 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 :
  1. Pain intensity and interference [ Time Frame: whole study-1 month ]
    Pain intensity and interference measured by the Brief Pain Inventory (BPI)

  2. Daily pain intensity measured by a numerical rating scale (NRS) by patients [ Time Frame: 1 month ]
    Daily pain intensity measured by a numerical rating scale (NRS) designed in a patient diary card

  3. Quality of life of the patients [ Time Frame: 1 month ]
    Quality of life measured by the EORTC QLQ-C30

  4. Quality of sleep of the patients [ Time Frame: 1 month ]
    Quality of sleep measured by a NRS

  5. Number of breakthrough pain [ Time Frame: 1 month ]
    Number of breakthrough pain during the observational period

  6. Treatment discontinuation and associated reasons [ Time Frame: during study period-1 month ]
    reason for stop treatments


Other Outcome Measures:
  1. ECG changes [ Time Frame: 1 month of study period ]
    The change from baseline in ECG measurement at each visit



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Caner patients with moderate to severe cancer pain
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04315831


Locations
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Taiwan
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
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Principal Investigator: Jen-Shi Chen, MD Chang Gung Memorial Hospital
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Responsible Party: Taiwan Mundipharma Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier: NCT04315831    
Other Study ID Numbers: BUP17-TW-401
First Posted: March 20, 2020    Key Record Dates
Last Update Posted: March 20, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share the individual participant data to other researchers unless formal request been reviewed and pproval

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Taiwan Mundipharma Pharmaceuticals Ltd.:
Transdermal Buprenorphine, Cancer pain, QOL, NRS, Narcotics
Additional relevant MeSH terms:
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Cancer Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Buprenorphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists