Back to resultsStudy Evaluating Safety and Tolerability of Oxycodone in Patients With Moderate to Severe Cancer Pain (STOP Pain)
Primary Purpose
Cancer, Pain
Status
Completed
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Oxycodone
Sponsored by
About this trial
This is an interventional treatment trial for Cancer focused on measuring Oxycodone, Cancer Pain, Long-term use
Eligibility Criteria
Inclusion Criteria:
- Cancer patients aged 20 years old and over
- ECOG ≤ 2
- Moderate to severe pain intensity (NRS pain score ≥ 4)
- Cancer-related pain that requires treatment with continuous around-the-clock strong opioid analgesic
- Patients who will not be treated with radiotherapy within 7 days prior to screening and during study
- Patients or his/her caregivers who are able to fill out the questionnaire forms
- Patient provided signed informed consent
Exclusion Criteria:
- Patients diagnosed with non-cancer pain or unexplained pain
- Patients who cannot be applicable for oral administration
- Patients who have constipation (CTCAE grade 3 and above)
- Patients with evidence of significant structural/functional abnormalities of GI tract or planned to undergo surgeries that have high risk lead to gastrointestinal stenosis, blind loop or gastrointestinal obstruction during study
- Abnormal lab results, with obvious clinical significance, such as the creatinine ≥ 2 fold of upper limit of normal value, or ALT or AST ≥ 2.5 fold of upper limit of normal value (≥ 5 fold, to the patients with liver metastasis or primary liver cancer), or liver function of Child C grade prior to study
- Pregnant or nursing (lactating) women
- Patients who are drug or alcohol abuse
- Patients with moderate to severe psychiatric problems
- Patients who have hypersensitivity to oxycodone
- Patients who are clinically unstable or have a life expectancy of less than three months making completion of the trial unlikely
Sites / Locations
- Changhua Christian Hospital
- Chang Gung Memorial Hospital, Chiayi branch
- Chang Gung Memorial Hospital, Kaohsiung branch
- Chang Gung Memorial Hospital, Keelung branch
- China Medical University Hospital
- Taichung Veterans General Hospital
- MacKay Memorial Hospital
- Shin Kong Wu Ho-Su Memorial Hospital
- Tri-Service General Hospital
- Chang Gung Memorial Hospital, LinKou branch
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Oxycodone treatment
Arm Description
Patients will take either control-released oxycodone (OxyContin® 10mg and 20mg) or immediate-released oxycodone (OxyNorm® 5mg) or both for initial dose and used it to titrate his/her background dose. After regular time assessment of the pain score (NRS), if the pain control is inadequate (NRS ≥ 4), a total daily dose in 24hrs will be summed up for the next dose titration until reach a stable dose (as defined as total daily dose is fixed for at least two weeks).
Outcomes
Primary Outcome Measures
Number and percentage of patients with adverse events (AEs) and serious adverse events (SAEs)
Number and percentage of patients with adverse events (AEs) and serious adverse events (SAEs)
Secondary Outcome Measures
Change from baseline pain intensity scale (NRS)
The change from baseline pain intensity scale (NRS) to each visit
Time (days) needs in first titration to a stable dose
The time (days) needs in first stable titration
Average dosage (mg/day) needs in first titration to a stable dose
The average dosage needs in first stable titration
Quality of analgesia using rating of excellent, very good, good, fair or poor
The percentage of patients rating quality of analgesia of excellent, very good, good, fair or poor
Treatment discontinuation reason (due to AE, withdraw consent, or any kinds of reasons)
Analysis treatment discontinue reason (due to AE, withdraw consent, or any kinds of reasons)
Change from baseline in QoL questionnaire (EQ-5D)
The change from baseline in QoL questionnaire (EQ-5D)
Opiate withdrawal level by Clinical Opiate Withdrawal Scale (COWS)
The change of clinical opiate withdrawal scale (COWS) from baseline
Safety and tolerability (PE and vital sign change from baseline)
The change from baseline in PE and vital sign
Full Information
NCT ID
NCT03176121
First Posted
May 22, 2017
Last Updated
March 16, 2020
Sponsor
Taiwan Mundipharma Pharmaceuticals Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03176121
Brief Title
Study Evaluating Safety and Tolerability of Oxycodone in Patients With Moderate to Severe Cancer Pain
Acronym
STOP Pain
Official Title
A Long Term, Open-Label, Multi-Center Study Evaluating Safety and Tolerability of Oxycodone in Patients With Moderate to Severe Cancer Pain
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
October 31, 2016 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taiwan Mundipharma Pharmaceuticals Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is to evaluate the safety and tolerability of oxycodone control-released (CR) and/or immediate-released (IR) use in patients with moderate to severe cancer pain in a 3-months period in Taiwan.
Detailed Description
This is an open label, long-term study carrying in multi-centers. Around 200 patients with moderate to severe cancer pain (NRS ≥ 4) who agreed and signed informed consent will be enrolled to receive oxycodone with continuous around-the-clock pattern. The study is to evaluate the safety and tolerability of cancer patients who receive CR and/or IR oxycodone. The number and percentage of patients with adverse events and serious adverse events will be recorded throughout the study.
The study will continue for 3 months to observe the safety and tolerability. After screening at Screening visit, patients begin the study by the first day visit (Day 1). Pain assessment, study related questionnaires are giving out to measure the baseline scale of each patient. Questionnaires including rate of quality of analgesia, EQ-5D and clinical opiate withdrawal scale (COWS). The prescription of the study drug will be recorded from Day 1. Patients will need to visit bi-weekly, including Wk 2 (Day 14±3), Wk 4 (Day 28±3), Wk 6 (Day 42±3), Wk 8 (Day 56±3), Wk 10 (Day 70±3) and Wk 12 (Day 84±3). Pain assessment will be assessed in each visit, drug accountability will be recorded accordingly. The rate of quality of Analgesia will be assessed in each visit; QoL (EQ-5D) will be recorded in Wk 4, Wk 8 and Wk 12. The COWS will be assessed again in Wk 12.
The safety for individual patient will be followed during study up to 2 weeks after the end of treatment (EOT) or early termination (ET). The telephone contact for safety follow-up is acceptable for this study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Pain
Keywords
Oxycodone, Cancer Pain, Long-term use
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
73 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oxycodone treatment
Arm Type
Experimental
Arm Description
Patients will take either control-released oxycodone (OxyContin® 10mg and 20mg) or immediate-released oxycodone (OxyNorm® 5mg) or both for initial dose and used it to titrate his/her background dose.
After regular time assessment of the pain score (NRS), if the pain control is inadequate (NRS ≥ 4), a total daily dose in 24hrs will be summed up for the next dose titration until reach a stable dose (as defined as total daily dose is fixed for at least two weeks).
Intervention Type
Drug
Intervention Name(s)
Oxycodone
Intervention Description
Patients will take either CR oxycodone or IR oxycodone or both for initial dose and used it to titrate his/her background dose.
Primary Outcome Measure Information:
Title
Number and percentage of patients with adverse events (AEs) and serious adverse events (SAEs)
Description
Number and percentage of patients with adverse events (AEs) and serious adverse events (SAEs)
Time Frame
Up to 14 weeks
Secondary Outcome Measure Information:
Title
Change from baseline pain intensity scale (NRS)
Description
The change from baseline pain intensity scale (NRS) to each visit
Time Frame
Up to 12 weeks
Title
Time (days) needs in first titration to a stable dose
Description
The time (days) needs in first stable titration
Time Frame
Up to 12 weeks
Title
Average dosage (mg/day) needs in first titration to a stable dose
Description
The average dosage needs in first stable titration
Time Frame
Up to 12 weeks
Title
Quality of analgesia using rating of excellent, very good, good, fair or poor
Description
The percentage of patients rating quality of analgesia of excellent, very good, good, fair or poor
Time Frame
Up to 12 weeks
Title
Treatment discontinuation reason (due to AE, withdraw consent, or any kinds of reasons)
Description
Analysis treatment discontinue reason (due to AE, withdraw consent, or any kinds of reasons)
Time Frame
Up to 12 weeks
Title
Change from baseline in QoL questionnaire (EQ-5D)
Description
The change from baseline in QoL questionnaire (EQ-5D)
Time Frame
Up to 12 weeks
Title
Opiate withdrawal level by Clinical Opiate Withdrawal Scale (COWS)
Description
The change of clinical opiate withdrawal scale (COWS) from baseline
Time Frame
Up to 12 weeks
Title
Safety and tolerability (PE and vital sign change from baseline)
Description
The change from baseline in PE and vital sign
Time Frame
Up to 14 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Cancer patients aged 20 years old and over
ECOG ≤ 2
Moderate to severe pain intensity (NRS pain score ≥ 4)
Cancer-related pain that requires treatment with continuous around-the-clock strong opioid analgesic
Patients who will not be treated with radiotherapy within 7 days prior to screening and during study
Patients or his/her caregivers who are able to fill out the questionnaire forms
Patient provided signed informed consent
Exclusion Criteria:
Patients diagnosed with non-cancer pain or unexplained pain
Patients who cannot be applicable for oral administration
Patients who have constipation (CTCAE grade 3 and above)
Patients with evidence of significant structural/functional abnormalities of GI tract or planned to undergo surgeries that have high risk lead to gastrointestinal stenosis, blind loop or gastrointestinal obstruction during study
Abnormal lab results, with obvious clinical significance, such as the creatinine ≥ 2 fold of upper limit of normal value, or ALT or AST ≥ 2.5 fold of upper limit of normal value (≥ 5 fold, to the patients with liver metastasis or primary liver cancer), or liver function of Child C grade prior to study
Pregnant or nursing (lactating) women
Patients who are drug or alcohol abuse
Patients with moderate to severe psychiatric problems
Patients who have hypersensitivity to oxycodone
Patients who are clinically unstable or have a life expectancy of less than three months making completion of the trial unlikely
Facility Information:
Facility Name
Changhua Christian Hospital
City
Chang-hua
ZIP/Postal Code
500
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital, Chiayi branch
City
Chiayi City
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital, Kaohsiung branch
City
Kaohsiung
ZIP/Postal Code
83301
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital, Keelung branch
City
Keelung
ZIP/Postal Code
204
Country
Taiwan
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Taichung Veterans General Hospital
City
Taichung
Country
Taiwan
Facility Name
MacKay Memorial Hospital
City
Taipei
ZIP/Postal Code
10449
Country
Taiwan
Facility Name
Shin Kong Wu Ho-Su Memorial Hospital
City
Taipei
ZIP/Postal Code
111
Country
Taiwan
Facility Name
Tri-Service General Hospital
City
Taipei
ZIP/Postal Code
114
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital, LinKou branch
City
Taoyuan City
ZIP/Postal Code
333
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
19244085
Citation
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Results Reference
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22300860
Citation
Caraceni A, Hanks G, Kaasa S, Bennett MI, Brunelli C, Cherny N, Dale O, De Conno F, Fallon M, Hanna M, Haugen DF, Juhl G, King S, Klepstad P, Laugsand EA, Maltoni M, Mercadante S, Nabal M, Pigni A, Radbruch L, Reid C, Sjogren P, Stone PC, Tassinari D, Zeppetella G; European Palliative Care Research Collaborative (EPCRC); European Association for Palliative Care (EAPC). Use of opioid analgesics in the treatment of cancer pain: evidence-based recommendations from the EAPC. Lancet Oncol. 2012 Feb;13(2):e58-68. doi: 10.1016/S1470-2045(12)70040-2.
Results Reference
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PubMed Identifier
25218610
Citation
Ahmedzai SH, Leppert W, Janecki M, Pakosz A, Lomax M, Duerr H, Hopp M. Long-term safety and efficacy of oxycodone/naloxone prolonged-release tablets in patients with moderate-to-severe chronic cancer pain. Support Care Cancer. 2015 Mar;23(3):823-30. doi: 10.1007/s00520-014-2435-5. Epub 2014 Sep 14.
Results Reference
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PubMed Identifier
17488292
Citation
Panchal SJ, Muller-Schwefe P, Wurzelmann JI. Opioid-induced bowel dysfunction: prevalence, pathophysiology and burden. Int J Clin Pract. 2007 Jul;61(7):1181-7. doi: 10.1111/j.1742-1241.2007.01415.x. Epub 2007 May 4.
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PubMed Identifier
20714946
Citation
Mueller-Lissner S. Fixed combination of oxycodone with naloxone: a new way to prevent and treat opioid-induced constipation. Adv Ther. 2010 Sep;27(9):581-90. doi: 10.1007/s12325-010-0057-y. Epub 2010 Aug 11.
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PubMed Identifier
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Citation
Mancini I, Bruera E. Constipation in advanced cancer patients. Support Care Cancer. 1998 Jul;6(4):356-64. doi: 10.1007/s005200050177.
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PubMed Identifier
15907646
Citation
Kalso E. Oxycodone. J Pain Symptom Manage. 2005 May;29(5 Suppl):S47-56. doi: 10.1016/j.jpainsymman.2005.01.010.
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20884999
Citation
Leppert W. Role of oxycodone and oxycodone/naloxone in cancer pain management. Pharmacol Rep. 2010 Jul-Aug;62(4):578-91. doi: 10.1016/s1734-1140(10)70316-9.
Results Reference
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PubMed Identifier
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Citation
Stessel B, Theunissen M, Fiddelers AA, Joosten EA, Kessels AG, Gramke HF, Marcus MA. Controlled-release oxycodone versus naproxen at home after ambulatory surgery: a randomized controlled trial. Curr Ther Res Clin Exp. 2014 Nov 28;76:120-5. doi: 10.1016/j.curtheres.2014.10.001. eCollection 2014 Dec.
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Citation
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Results Reference
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Study Evaluating Safety and Tolerability of Oxycodone in Patients With Moderate to Severe Cancer Pain
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