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

NCT03176121 | Completed Phase 4

• 1 other identifier: OXY16-TW-401
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 10

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.

Conditions

Cancer; Pain

Keywords

Oxycodone; Cancer Pain; Long-term use

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Change from baseline pain intensity scale (NRS)

  Up to 12 weeks

• Time (days) needs in first titration to a stable dose

  Up to 12 weeks

• Average dosage (mg/day) needs in first titration to a stable dose

  Up to 12 weeks

• Quality of analgesia using rating of excellent, very good, good, fair or poor

  Up to 12 weeks

• Treatment discontinuation reason (due to AE, withdraw consent, or any kinds of reasons)

  Up to 12 weeks

Study Arms (1)

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).

Drug: Oxycodone

Interventions

Oxycodone DRUG

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

Oxycodone treatment

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taiwan Mundipharma Pharmaceuticals Ltd.: lead

Study Sites (10)

Changhua Christian Hospital

Chang-hua, 500, Taiwan

Location

Chang Gung Memorial Hospital, Chiayi branch

Chiayi City, Taiwan

Location

Chang Gung Memorial Hospital, Kaohsiung branch

Kaohsiung City, 83301, Taiwan

Location

Chang Gung Memorial Hospital, Keelung branch

Keelung, 204, Taiwan

Location

China Medical University Hospital

Taichung, 40447, Taiwan

Location

Taichung Veterans General Hospital

Taichung, Taiwan

Location

MacKay Memorial Hospital

Taipei, 10449, Taiwan

Location

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, 111, Taiwan

Location

Tri-Service General Hospital

Taipei, 114, Taiwan

Location

Chang Gung Memorial Hospital, LinKou branch

Taoyuan, 333, Taiwan

Location

Related Publications (10)

• 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.

  PMID: 19244085 BACKGROUND

• 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.

  PMID: 22300860 BACKGROUND

• 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.

  PMID: 25218610 BACKGROUND

• 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.

  PMID: 17488292 BACKGROUND

• 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.

  PMID: 20714946 BACKGROUND

• Mancini I, Bruera E. Constipation in advanced cancer patients. Support Care Cancer. 1998 Jul;6(4):356-64. doi: 10.1007/s005200050177.

  PMID: 9695203 BACKGROUND

• Kalso E. Oxycodone. J Pain Symptom Manage. 2005 May;29(5 Suppl):S47-56. doi: 10.1016/j.jpainsymman.2005.01.010.

  PMID: 15907646 BACKGROUND

• 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.

  PMID: 20884999 BACKGROUND

• 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.

  PMID: 25516773 BACKGROUND

• 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. doi: 10.1016/s0885-3924(99)00079-2.

  PMID: 10534967 BACKGROUND

MeSH Terms

Conditions

Neoplasms; Pain; Cancer Pain

Interventions

Oxycodone

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2017
• First Posted: June 5, 2017
• Study Start: October 31, 2016
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: March 18, 2020

Record last verified: 2017-06

Locations

TW (10)