- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02335398
Development and Evaluation of a Methadone Protocol for Severe Chronic Pain Management
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
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Bangkok
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Bangkoknoi, Bangkok, Thailand, 10700
- Siriraj Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: methadone
single group
|
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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain score
Time Frame: 3 months
|
pain scores are assessed at baseline, and two, four, eight, and twelve weeks after starting methadone.
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
pain interferences scores
Time Frame: 3 months
|
pain interferences scores are assessed at baseline, and two, four, eight, and twelve weeks after starting methadone.
|
3 months
|
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 months
|
QTc intervals
Time Frame: 3 months
|
QTc intervals are assessed at baseline, and two, four, eight, and twelve weeks after starting methadone
|
3 months
|
Neuropathic pain score
Time Frame: 3 months
|
Neuropathic pain score are assessed at baseline, and two, four, eight, and twelve weeks after starting methadone
|
3 months
|
Collaborators and Investigators
Sponsor
Investigators
- 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 and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 289/2554(EC4)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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