A Study to Compare the Titration Efficacy and Safety of Control-released Oxycodone and Immediate-released Oxycodone in Patients With Moderate to Severe Cancer Pain

NCT03176199 | Completed Phase 4

• 1 other identifier: OXY15-TW-401
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 4

Brief Summary

This study is to evaluate the efficacy and safety of a titration method by selects 10 mg control-released (CR) oxycodone tablet as background drug in combined with immediate-released (IR) oxycodone, compared to conventional titration method with immediate-released (IR) oxycodone in patients with moderate to severe cancer pain in Taiwan.

Conditions

Cancer; Pain

Keywords

control-released oxycodone; immediate-released oxycodone; cancer pain; opioid-naive

Outcome Measures

Primary Outcomes (1)

• To evaluate the variable change of NRS pain score and the number of breakthrough pain to obtain pain control after treatment

  The change from baseline of NRS pain score and the daily number of breakthrough pain

  Up to 14 days

Secondary Outcomes (7)

• To evaluate the percentage of patients in each titration cycle

  Up to 14 days

• To evaluate the number of patients who switched/discontinued therapy due to serious adverse events or lack of pain control

  Up to 14 days

• The total opioid taken within 24hrs daily from baseline to day 14

  Up to 14 days

• To evaluate the mean daily NRS score of subjects from baseline to day 14

  Up to 14 days

• To evaluate the total daily rescue dose taken (immediate-released oxycodone capsule) for treatment of breakthrough pain among patients from baseline to day 14

  Up to 14 days

Study Arms (2)

Control-released oxycodone

EXPERIMENTAL

Control-released oxycodone Q12H, initial daily dose is 20 mg + immediate-released oxycodone for PRN

Drug: Oxycodone

Immediate-released oxycodone

ACTIVE COMPARATOR

Immediate-released oxycodone Q6H, initial daily dose is 20mg + immediate-released oxycodone for PRN

Drug: Oxycodone

Interventions

Oxycodone DRUG

Every 12 hours for control-released oxycodone (OxyContin®)

Control-released oxycodone

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
• Patients with background cancer pain more than or equal to NRS 4 during previous 24 hours, or receive more than or equal to 3 times/day for breakthrough pain medication management
• ECOG ≤ 2
• Opioid-naive patients who are not administrated any strong opioid for at least one month prior to the index treatments, who currently with poor pain control and intended to be treated for pain relief with strong opioids. The FDA identifies opioid-naive as who not receiving the following treatment for a week or longer of strong opioids:
• \) ≥ 60 mg of morphine daily 2) ≥25 mcg transdermalfentanyl/hour 3) ≥ 8 mg of oral hydromorphone daily or 4) an equianalgesic dose of another opioid
• \) Patients who will not be treated with radiotherapy within 7 days prior to randomization and during study
• \) Patients who need chemotherapy, long term administration of hormone, targeted therapy, or bisphosphonates therapy should undergo a stable anti-tumor therapy prior to randomization.
• \) Patients or his/her caregivers who are able to fill out the diary and questionnaire forms

You may not qualify if:

• Patients diagnosed with non-cancer pain or unexplained pain
• Patients suffered with post-op pain
• Patients who cannot be applicable for oral administration
• Patients who have severe constipation defined by CTCAE grade 3 and above
• Patients with any disease that may easily lead to respiratory depression
• Monoamine oxidase inhibitor (MAOI) was administrated one week before randomization
• There are 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
• Patients who have potential risk for surgical operation, which may lead to gastrointestinal stenosis, blind loop or gastrointestinal obstruction; or patient is unable to effectively absorb oral medication through gastrointestinal tract
• Patients who are drug or alcohol abuse
• Patients with moderate to severe psychiatric problems
• Patients who have hypersensitivity to oxycodone
• Patients who are pregnant or lactating
• 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 (4)

Changhua Christian Hospital

Chang-hua, 500, Taiwan

Location

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

Location

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

Related Publications (7)

• Mercadante S, Porzio G, Ferrera P, Fulfaro F, Aielli F, Ficorella C, Verna L, Tirelli W, Villari P, Arcuri E. Low morphine doses in opioid-naive cancer patients with pain. J Pain Symptom Manage. 2006 Mar;31(3):242-7. doi: 10.1016/j.jpainsymman.2006.01.001.

  PMID: 16563318 BACKGROUND

• Mercadante S. Opioid titration in cancer pain: a critical review. Eur J Pain. 2007 Nov;11(8):823-30. doi: 10.1016/j.ejpain.2007.01.003. Epub 2007 Feb 28.

  PMID: 17331764 BACKGROUND

• Klepstad P, Kaasa S, Jystad A, Hval B, Borchgrevink PC. Immediate- or sustained-release morphine for dose finding during start of morphine to cancer patients: a randomized, double-blind trial. Pain. 2003 Jan;101(1-2):193-8. doi: 10.1016/s0304-3959(02)00328-7.

  PMID: 12507714 BACKGROUND

• Ripamonti CI, Santini D, Maranzano E, Berti M, Roila F; ESMO Guidelines Working Group. Management of cancer pain: ESMO Clinical Practice Guidelines. Ann Oncol. 2012 Oct;23 Suppl 7:vii139-54. doi: 10.1093/annonc/mds233. No abstract available.

  PMID: 22997447 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

• Pan H, Zhang Z, Zhang Y, Xu N, Lu L, Dou C, Guo Y, Wu S, Yue J, Wu D, Dai Y. Efficacy and tolerability of oxycodone hydrochloride controlled-release tablets in moderate to severe cancer pain. Clin Drug Investig. 2007;27(4):259-67. doi: 10.2165/00044011-200727040-00005.

  PMID: 17358098 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 Officials

• Chih-Jen Hung, MSc

  Taichung Veterans General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2017
• First Posted: June 5, 2017
• Study Start: September 1, 2016
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: March 18, 2020

Record last verified: 2017-06

Locations

TW (4)