Clinical trial · Interventional
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
An Interventional, Open Label, and Randomized Controlled Study to Compare the Titration Efficacy and Safety of Control-released Oxycodone and Immediate-released Oxycodone in Opioid-naive Patients With Moderate to Severe Cancer Pain
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Pain | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oxycodone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Control-released oxycodone
- description
- Control-released oxycodone Q12H, initial daily dose is 20 mg + immediate-released oxycodone for PRN
- interventionNames
- Drug: Oxycodone
- type
- ACTIVE_COMPARATOR
- label
- Immediate-released oxycodone
- description
- Immediate-released oxycodone Q6H, initial daily dose is 20mg + immediate-released oxycodone for PRN
- interventionNames
- Drug: Oxycodone
Primary outcomes (1)
- measure
- To evaluate the variable change of NRS pain score and the number of breakthrough pain to obtain pain control after treatment
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: 1. Cancer patients aged 20 years old and over 2. 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 3. ECOG ≤ 2 4. 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: 1\) ≥ 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 5\) Patients who will not be treated with radiotherapy within 7 days prior to randomization and during study 6\) Patients who need chemotherapy, long term administration of hormone, targeted therapy, or bisphosphonates therapy should undergo a stable anti-tumor therapy prior to randomization. 7\) Patients or his/her caregivers who are able to fill out the diary and questionnaire forms Exclusion Criteria: 1. Patients diagnosed with non-cancer pain or unexplained pain 2. Patients suffered with post-op pain 3. Patients who cannot be applicable for oral administration 4. Patients who have severe constipation defined by CTCAE grade 3 and above 5. Patients with any disease that may easily lead to respiratory depression 6. Monoamine oxidase inhibitor (MAOI) was administrated one week before randomization 7. 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 8. 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 9. Patients who are drug or alcohol abuse 10. Patients with moderate to severe psychiatric problems 11. Patients who have hypersensitivity to oxycodone 12. Patients who are pregnant or lactating 13. Patients who are clinically unstable or have a life expectancy of less than three months making completion of the trial unlikely
References
Publications (7)
- BACKGROUNDMercadante 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
- BACKGROUNDMercadante 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
- BACKGROUNDKlepstad 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
- BACKGROUNDRipamonti 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
- BACKGROUNDCaraceni 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
- BACKGROUNDPan 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