CancerPhase 4STOP PainNCT03176121
Study Evaluating Safety and Tolerability of Oxycodone in Patients With Moderate to Severe Cancer Pain
A Phase 4 study testing Oxycodone in people with Cancer and Pain, run by Taiwan Mundipharma Pharmaceuticals Ltd. at 10 sites in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- What is being tested?
- Oxycodone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 10 sitesTaiwan
- Study dates
- 31 Oct 2016to 31 Dec 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Taiwan10 sites
Changhua Christian Hospital
Chang-hua, 500
Chang Gung Memorial Hospital, Chiayi branch
Chiayi City
Chang Gung Memorial Hospital, Kaohsiung branch
Kaohsiung City, 83301
Chang Gung Memorial Hospital, Keelung branch
Keelung, 204
China Medical University Hospital
Taichung, 40447
Taichung Veterans General Hospital
Taichung
MacKay Memorial Hospital
Taipei, 10449
Shin Kong Wu Ho-Su Memorial Hospital
Taipei, 111
Tri-Service General Hospital
Taipei, 114
Chang Gung Memorial Hospital, LinKou branch
Taoyuan City, 333
About this study
Official title: A Long Term, Open-Label, Multi-Center Study Evaluating Safety and Tolerability of Oxycodone in Patients With Moderate to Severe Cancer Pain
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.
Read the 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.
- Being tested
- Oxycodone
- Keywords
- Oxycodone, Cancer Pain, Long-term use
- Medical subject headings
- Neoplasms, Pain, Cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxycodoneDrug
Patients will take either CR oxycodone or IR oxycodone or both for initial dose and used it to titrate his/her background dose.
| Study group | Role | What they receive |
|---|---|---|
| Oxycodone treatment | Experimental | 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). Receives: Drug: Oxycodone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Up to 14 weeks
Secondary outcomes (8)
Change from baseline pain intensity scale (NRS)
The change from baseline pain intensity scale (NRS) to each visit
Measured: Up to 12 weeks
Time (days) needs in first titration to a stable dose
The time (days) needs in first stable titration
Measured: Up to 12 weeks
Average dosage (mg/day) needs in first titration to a stable dose
The average dosage needs in first stable titration
Measured: Up to 12 weeks
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
Measured: Up to 12 weeks
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)
Measured: Up to 12 weeks
Change from baseline in QoL questionnaire (EQ-5D)
The change from baseline in QoL questionnaire (EQ-5D)
Measured: Up to 12 weeks
Opiate withdrawal level by Clinical Opiate Withdrawal Scale (COWS)
The change of clinical opiate withdrawal scale (COWS) from baseline
Measured: Up to 12 weeks
Safety and tolerability (PE and vital sign change from baseline)
The change from baseline in PE and vital sign
Measured: Up to 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2017
- Study start31 Oct 2016
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taiwan Mundipharma Pharmaceuticals Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03176121
- Sponsor's protocol ID
- OXY16-TW-401
- Acronym
- STOP Pain
- Status last verified
- Jun 2017
- First submitted
- 22 May 2017
- Last updated
- 18 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Breivik H, Cherny N, Collett B, de Conno F, Filbet M, Foubert AJ, Cohen R, Dow L. Cancer-related pain: a pan-European survey of prevalence, treatment, and patient attitudes. Ann Oncol. 2009 Aug;20(8):1420-33. doi: 10.1093/annonc/mdp001. Epub 2009 Feb 24.
PubMed 19244085Caraceni 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.
PubMed 22300860Ahmedzai 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.
PubMed 25218610Panchal 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.
PubMed 17488292Mueller-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.
PubMed 20714946Mancini I, Bruera E. Constipation in advanced cancer patients. Support Care Cancer. 1998 Jul;6(4):356-64. doi: 10.1007/s005200050177.
PubMed 9695203Kalso E. Oxycodone. J Pain Symptom Manage. 2005 May;29(5 Suppl):S47-56. doi: 10.1016/j.jpainsymman.2005.01.010.
PubMed 15907646Leppert 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.
PubMed 20884999Stessel 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.
PubMed 25516773Salzman RT, Roberts MS, Wild J, Fabian C, Reder RF, Goldenheim PD. Can a controlled-release oral dose form of oxycodone be used as readily as an immediate-release form for the purpose of titrating to stable pain control? J Pain Symptom Manage. 1999 Oct;18(4):271-9. doi: 10.1016/s0885-3924(99)00079-2.
PubMed 10534967
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long Term, Open-Label, Multi-Center Study Evaluating Safety and Tolerability of Oxycodone in Patients With Moderate to Severe Cancer Pain
- ClinicalTrials.gov ID
- NCT03176121
- Acronym / sponsor ID
- STOP Pain / OXY16-TW-401
- Keywords
- Oxycodone, Cancer Pain, Long-term use
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Taiwan Mundipharma Pharmaceuticals Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Oct 2016 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 5 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oxycodone treatment | Experimental | Drug: OxycodonePatients 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). |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxycodonePatients will take either CR oxycodone or IR oxycodone or both for initial dose and used it to titrate his/her background dose. | Drug | Oxycodone treatment |
Primary outcome
Number and percentage of patients with adverse events (AEs) and serious adverse events (SAEs)
Time frame: Up to 14 weeks
Number and percentage of patients with adverse events (AEs) and serious adverse events (SAEs)
8 secondary outcomes
Change from baseline pain intensity scale (NRS)
Time frame: Up to 12 weeks
Time (days) needs in first titration to a stable dose
Time frame: Up to 12 weeks
Average dosage (mg/day) needs in first titration to a stable dose
Time frame: Up to 12 weeks
Quality of analgesia using rating of excellent, very good, good, fair or poor
Time frame: Up to 12 weeks
Treatment discontinuation reason (due to AE, withdraw consent, or any kinds of reasons)
Time frame: Up to 12 weeks
Change from baseline in QoL questionnaire (EQ-5D)
Time frame: Up to 12 weeks
Opiate withdrawal level by Clinical Opiate Withdrawal Scale (COWS)
Time frame: Up to 12 weeks
Safety and tolerability (PE and vital sign change from baseline)
Time frame: Up to 14 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
- Background: PubMed 19244085Breivik H, Cherny N, Collett B, de Conno F, Filbet M, Foubert AJ, Cohen R, Dow L. Cancer-related pain: a pan-European survey of prevalence, treatment, and patient attitudes. Ann Oncol. 2009 Aug;20(8):1420-33. doi: 10.1093/annonc/mdp001. Epub 2009 Feb 24.
- Background: PubMed 22300860Caraceni 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.
- Background: PubMed 25218610Ahmedzai 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.
- Background: PubMed 17488292Panchal 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.
- Background: PubMed 20714946Mueller-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.
- Background: PubMed 9695203Mancini I, Bruera E. Constipation in advanced cancer patients. Support Care Cancer. 1998 Jul;6(4):356-64. doi: 10.1007/s005200050177.
- Background: PubMed 15907646Kalso E. Oxycodone. J Pain Symptom Manage. 2005 May;29(5 Suppl):S47-56. doi: 10.1016/j.jpainsymman.2005.01.010.
- Background: PubMed 20884999Leppert 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.
- Background: PubMed 25516773Stessel 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.
- Background: PubMed 10534967Salzman RT, Roberts MS, Wild J, Fabian C, Reder RF, Goldenheim PD. Can a controlled-release oral dose form of oxycodone be used as readily as an immediate-release form for the purpose of titrating to stable pain control? J Pain Symptom Manage. 1999 Oct;18(4):271-9. doi: 10.1016/s0885-3924(99)00079-2.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oxycodone in people with Cancer and Pain, run by Taiwan Mundipharma Pharmaceuticals Ltd. at 10 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and percentage of patients with adverse events (AEs) and serious adverse events (SAEs) (time frame: Up to 14 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03176121, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2020.