Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Development and Evaluation of a Methadone Protocol for Severe Chronic Pain Management

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02335398
Recruitment Status : Completed
First Posted : January 9, 2015
Last Update Posted : January 9, 2015
Sponsor:
Information provided by (Responsible Party):
Mahidol University

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.

Condition or disease Intervention/treatment Phase
Pain, Chronic Drug: Methadone Phase 4

Detailed Description:

Chronic pain is defined as pain that persists beyond normal tissue healing time, which is assumed for 3 months by the IASP. The symptoms include either continuous or intermittent pain, that could be caused by tumor or other multiple etiologies. The consequence of uncontrolled chronic pain presents not only physiologic symptoms but also psychiatric disorders leading to severely impact daily living.

In Thailand, the use of methadone for pain management has been limited because physicians are not familiar with its dosing and concern about the risk of drug accumulation and cardiac arrhythmia. Therefore, the aim of this study is to evaluate the efficacy and safety of a protocol of methadone dosing in outpatients with severe chronic pain.

Thirty four chronic pain patients will be included to initiate methadone use following the protocol. Pain scores, pain interferences scores, neuropathic pain score, severity of adverse effects, and QTc intervals will be assessed at baseline, and two, four, eight, and twelve weeks after starting methadone.

The approved protocol of methadone therapy obtained from this study could be clinically utilized by physicians for severe chronic pain management.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Development and Evaluation of a Methadone Protocol for Severe Chronic Pain Management
Study Start Date : July 2011
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: methadone
single group
Drug: Methadone
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.
Other Name: Methadone GPO




Primary Outcome Measures :
  1. Pain score [ Time Frame: 3 months ]
    pain scores are assessed at baseline, and two, four, eight, and twelve weeks after starting methadone.


Secondary Outcome Measures :
  1. pain interferences scores [ Time Frame: 3 months ]
    pain interferences scores are assessed at baseline, and two, four, eight, and twelve weeks after starting methadone.

  2. severity of adverse effects [ Time Frame: 3 months ]
    severity of adverse effects are assessed at baseline, and two, four, eight, and twelve weeks after starting methadone

  3. QTc intervals [ Time Frame: 3 months ]
    QTc intervals are assessed at baseline, and two, four, eight, and twelve weeks after starting methadone

  4. Neuropathic pain score [ Time Frame: 3 months ]
    Neuropathic pain score are assessed at baseline, and two, four, eight, and twelve weeks after starting methadone



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02335398


Locations
Layout table for location information
Thailand
Siriraj Hospital
Bangkoknoi, Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Investigators
Layout table for investigator information
Study Chair: Chuthamanee Suthisisang, Ph.D. Thailand: Faculty of Pharmacy, Mahidol University
Principal Investigator: Phutsadee Pudchakan, Bsc.Pharm Thailand: Faculty of Pharmacy, Mahidol University
Study Director: Krittika Tanyasaensook, Ph.D. Thailand: Faculty of Pharmacy, Mahidol University
Study Director: Pongparadee Chaudakshetrin, M.D. Thailand: Faculty of Medicine Siriraj Hospital

Publications:
Layout table for additonal information
Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT02335398     History of Changes
Other Study ID Numbers: 289/2554(EC4)
First Posted: January 9, 2015    Key Record Dates
Last Update Posted: January 9, 2015
Last Verified: January 2015
Keywords provided by Mahidol University:
methadone
chronic pain
noncancer pain
cancer pain
QTc prolongation
Additional relevant MeSH terms:
Layout table for MeSH terms
Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Methadone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents