Study Evaluating Safety and Tolerability of Oxycodone in Patients With Moderate to Severe Cancer Pain

Pain Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03176121
• Other study ID #: OXY16-TW-401
• Status: Completed
• Phase: Phase 4
• Start date: October 31, 2016
• Est. completion date: December 31, 2018

Study information

• Verified date: June 2017
• Source: Taiwan Mundipharma Pharmaceuticals Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• 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 = 2

3. Moderate to severe pain intensity (NRS pain score = 4)

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

5. Patients who will not be treated with radiotherapy within 7 days prior to screening and during study

6. Patients or his/her caregivers who are able to 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 cannot be applicable for oral administration

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

4. 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

5. 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

6. Pregnant or nursing (lactating) women

7. Patients who are drug or alcohol abuse

8. Patients with moderate to severe psychiatric problems

9. Patients who have hypersensitivity to oxycodone

10. Patients who are clinically unstable or have a life expectancy of less than three months making completion of the trial unlikely

Related Conditions & MeSH terms

• Cancer
• Cancer Pain
• Pain

Intervention

Drug:
• Oxycodone
Patients will take either CR oxycodone or IR oxycodone or both for initial dose and used it to titrate his/her background dose.

Locations

Country	Name	City	State
Taiwan	Changhua Christian Hospital	Chang-hua
Taiwan	Chang Gung Memorial Hospital, Chiayi branch	Chiayi City
Taiwan	Chang Gung Memorial Hospital, Kaohsiung branch	Kaohsiung
Taiwan	Chang Gung Memorial Hospital, Keelung branch	Keelung
Taiwan	China Medical University Hospital	Taichung
Taiwan	Taichung Veterans General Hospital	Taichung
Taiwan	MacKay Memorial Hospital	Taipei
Taiwan	Shin Kong Wu Ho-Su Memorial Hospital	Taipei
Taiwan	Tri-Service General Hospital	Taipei
Taiwan	Chang Gung Memorial Hospital, LinKou branch	Taoyuan City

Sponsors (1)

Lead Sponsor	Collaborator
Taiwan Mundipharma Pharmaceuticals Ltd.

Country where clinical trial is conducted

Taiwan, 

References & Publications (10)

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. — View Citation

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. — View 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. Review. — View Citation

Kalso E. Oxycodone. J Pain Symptom Manage. 2005 May;29(5 Suppl):S47-56. Review. — View Citation

Leppert W. Role of oxycodone and oxycodone/naloxone in cancer pain management. Pharmacol Rep. 2010 Jul-Aug;62(4):578-91. Review. — View Citation

Mancini I, Bruera E. Constipation in advanced cancer patients. Support Care Cancer. 1998 Jul;6(4):356-64. Review. — View 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. Review. — View Citation

Panchal SJ, Müller-Schwefe P, Wurzelmann JI. Opioid-induced bowel dysfunction: prevalence, pathophysiology and burden. Int J Clin Pract. 2007 Jul;61(7):1181-7. Epub 2007 May 4. Review. — View Citation

Salzman 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Up to 14 weeks
Secondary	Change from baseline pain intensity scale (NRS)	The change from baseline pain intensity scale (NRS) to each visit	Up to 12 weeks
Secondary	Time (days) needs in first titration to a stable dose	The time (days) needs in first stable titration	Up to 12 weeks
Secondary	Average dosage (mg/day) needs in first titration to a stable dose	The average dosage needs in first stable titration	Up to 12 weeks
Secondary	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	Up to 12 weeks
Secondary	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)	Up to 12 weeks
Secondary	Change from baseline in QoL questionnaire (EQ-5D)	The change from baseline in QoL questionnaire (EQ-5D)	Up to 12 weeks
Secondary	Opiate withdrawal level by Clinical Opiate Withdrawal Scale (COWS)	The change of clinical opiate withdrawal scale (COWS) from baseline	Up to 12 weeks
Secondary	Safety and tolerability (PE and vital sign change from baseline)	The change from baseline in PE and vital sign	Up to 14 weeks