Efficacy and Safety of Ultra-low Dose Methadone as Adjuvant Analgesic in Cancer Patients With Pain

Pain, Intractable Clinical Trial

— UDOME  

Official title:

A Double Blind Randomized Clinical Trial to Investigate the Efficacy and Safety of Ultra-low Dose Methadone as Adjuvant Analgesic Therapy in Cancer Patients With Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02687347
• Other study ID #: 15-369 MP-CUSM
• Status: Recruiting
• Phase: Phase 3
• First received: February 8, 2016
• Last updated: September 16, 2016
• Start date: February 2016
• Est. completion date: December 2018

Study information

• Verified date: September 2016
• Source: McGill University Health Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The research hypothesis of this study is: In patients with moderate to severe cancer related pain, the addition of low dose methadone to an existing opioid significantly reduces pain severity compared to low doses morphine.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 204
• Est. completion date: December 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients diagnosed of cancer-related pain of more than 3 months duration

• Pain relief during the last week rated unsatisfactory by the patient

• Pain severity during the last week rated moderate (between 4 and 7/10)

• Analgesic therapy must have been stable for 7 days

• Able to understand English or French

• Willing and able to give written informed consent

Exclusion Criteria:

• Patients who are currently receiving or have received methadone as analgesic in the last 6 months

• Contraindication to receive methadone (allergy, QTc segment on the ECG>450msec, concurrent treatment with medication that could increase methadone's effects)

• Patients presenting with changes in their cancer status/treatment with potential effects on their pain severity, during the duration of the trial (eg: new metastasis, indication for radiotherapy)

• Patients whose life expectancy is shorter than 2 months

• Patients with cognitive impairment presenting with difficulties understanding the trial and completing the research questionnaires

• Pregnant or lactating women (women of childbearing potential must have negative pregnancy test)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Pain, Intractable

Intervention

Drug:
• oral methadone
Oral methadone is the study drug
• oral morphine
Oral morphine is the active comparator. It is not a placebo intervention

Locations

Country	Name	City	State
Canada	Alan Edwards Pain Management Unit. Mcgill University Health Centre	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
McGill University Health Center

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	pain interference	Brief Pain Inventory: Composite questions 9-A to 9-G	2 months	No
Primary	pain relief	1) Pain item of the Edmonton Symptom Assessment Scale	2 months	No
Primary	pain relief	Questions 3 to 6 of the Brief Pain Inventory	2 months	No
Secondary	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0".	prevalence and severity of opioid induced side effects	2 months	Yes