NCT02335398

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jul 2011

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 7, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 9, 2015

Completed
Last Updated

January 9, 2015

Status Verified

January 1, 2015

Enrollment Period

2.4 years

First QC Date

January 7, 2015

Last Update Submit

January 7, 2015

Conditions

Pain, Chronic

Keywords

methadonechronic painnoncancer paincancer painQTc prolongation

Outcome Measures

Primary Outcomes (1)

  • Pain score

    pain scores are assessed at baseline, and two, four, eight, and twelve weeks after starting methadone.

    3 months

Secondary Outcomes (4)

  • pain interferences scores

    3 months

  • severity of adverse effects

    3 months

  • QTc intervals

    3 months

  • Neuropathic pain score

    3 months

Study Arms (1)

methadone

EXPERIMENTAL

single group

Drug: Methadone

Interventions

MethadoneDRUG

The starting methadone dose for naïve-opioid patients was 2.5-5 mg every 8-12 hours. In patients who required opioid rotation, the conversion ratios, morphine:methadone, were 4:1, 8:1, and 12:1 for patients receiving less than 90 mg of morphine, receiving 90-300 mg of morphine, and receiving more than 300 mg of morphine , respectively. A fixed dose ratio of 1:20 was applied for changing from transdermal fentanyl to oral methadone. Then, the daily calculated methadone dose was divided into 8-12 hourly dosing. Calculated rescue dose was estimated to be 10-15% of total daily dose of methadone which there was switched to be morphine syrup in the ratio of 1:4.

Also known as: Methadone GPO
methadone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Outpatients aged 18 or over who suffered from severe chronic cancer or noncancer pain to be firstly treated with methadone as analgesics

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Siriraj Hospital

Bangkoknoi, Bangkok, 10700, Thailand

Location

Related Publications (5)

  • Mercadante 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: 10506634BACKGROUND

  • Mercadante 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: 11387363BACKGROUND

  • Ripamonti 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: 9779694BACKGROUND

  • Bruera 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: 11839235BACKGROUND

  • Pearson 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: 15918160BACKGROUND

MeSH Terms

Conditions

Chronic PainCancer Pain

Interventions

Methadone

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

KetonesOrganic Chemicals

Study Officials

  • Chuthamanee Suthisisang, Ph.D.

    Thailand: Faculty of Pharmacy, Mahidol University

    STUDY CHAIR

  • Phutsadee Pudchakan, Bsc.Pharm

    Thailand: Faculty of Pharmacy, Mahidol University

    PRINCIPAL INVESTIGATOR

  • Krittika Tanyasaensook, Ph.D.

    Thailand: Faculty of Pharmacy, Mahidol University

    STUDY DIRECTOR

  • Pongparadee Chaudakshetrin, M.D.

    Thailand: Faculty of Medicine Siriraj Hospital

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

January 7, 2015

First Posted

January 9, 2015

Study Start

July 1, 2011

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

January 9, 2015

Record last verified: 2015-01

Locations

TH(1)