Clinical trial · Interventional
Development and Evaluation of a Methadone Protocol for Severe Chronic Pain Management
NCT02335398CI-TRIAL-00016568completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- 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)
Methadone is a synthetic mu opioid agonist that has been proved as clinically effective in pain management. However, methadone usage for pain control in Thailand has been limited because physicians are not familiar with its dosing and concern about the risk of drug accumulation and cardiac arrhythmia. Therefore, this prospective study was conducted to evaluate the efficacy and safety of a methadone protocol in Thai patients with severe chronic noncancer and cancer pain.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pain, Chronic | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Methadone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- methadone
- description
- single group
- interventionNames
- Drug: Methadone
Primary outcomes (1)
- measure
- Pain score
- timeFrame
- 3 months
- description
- pain scores are assessed at baseline, and two, four, eight, and twelve weeks after starting methadone.
Secondary outcomes (4)
- measure
- pain interferences scores
- timeFrame
- 3 months
- description
- pain interferences scores are assessed at baseline, and two, four, eight, and twelve weeks after starting methadone.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Outpatients aged 18 or over who suffered from severe chronic cancer or noncancer pain to be firstly treated with methadone as analgesics Exclusion Criteria: * QTc interval that was more than 500 msec * History of opioid addiction * Having structural heart diseases * During pregnancy or lactation period * Patients who have hypersensitivity to methadone
References
Publications (5)
- BACKGROUNDMercadante S, Casuccio A, Calderone L. Rapid switching from morphine to methadone in cancer patients with poor response to morphine. J Clin Oncol. 1999 Oct;17(10):3307-12. doi: 10.1200/JCO.1999.17.10.3307. PMID 10506634
- BACKGROUNDMercadante S, Casuccio A, Fulfaro F, Groff L, Boffi R, Villari P, Gebbia V, Ripamonti C. Switching from morphine to methadone to improve analgesia and tolerability in cancer patients: a prospective study. J Clin Oncol. 2001 Jun 1;19(11):2898-904. doi: 10.1200/JCO.2001.19.11.2898. PMID 11387363
- BACKGROUNDRipamonti C, Groff L, Brunelli C, Polastri D, Stavrakis A, De Conno F. Switching from morphine to oral methadone in treating cancer pain: what is the equianalgesic dose ratio? J Clin Oncol. 1998 Oct;16(10):3216-21. doi: 10.1200/JCO.1998.16.10.3216. PMID 9779694
- BACKGROUNDBruera E, Sweeney C. Methadone use in cancer patients with pain: a review. J Palliat Med. 2002 Feb;5(1):127-38. doi: 10.1089/10966210252785097. PMID 11839235
- BACKGROUNDPearson EC, Woosley RL. QT prolongation and torsades de pointes among methadone users: reports to the FDA spontaneous reporting system. Pharmacoepidemiol Drug Saf. 2005 Nov;14(11):747-53. doi: 10.1002/pds.1112. PMID 15918160