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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT02335398 |
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Date of registration:
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07/01/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Development and Evaluation of a Methadone Protocol for Severe Chronic Pain Management
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Scientific title:
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Development and Evaluation of a Methadone Protocol for Severe Chronic Pain Management |
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Date of first enrolment:
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July 2011 |
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Target sample size:
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34 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT02335398 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Thailand
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Contacts
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Name:
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Phutsadee Pudchakan, Bsc.Pharm |
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Address:
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Telephone:
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Email:
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Affiliation:
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Thailand: Faculty of Pharmacy, Mahidol University |
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Name:
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Krittika Tanyasaensook, Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Thailand: Faculty of Pharmacy, Mahidol University |
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Name:
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Pongparadee Chaudakshetrin, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Thailand: Faculty of Medicine Siriraj Hospital |
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Name:
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Chuthamanee Suthisisang, Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Thailand: Faculty of Pharmacy, Mahidol University |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Pain, Chronic
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Intervention(s)
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Drug: Methadone
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Primary Outcome(s)
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Pain score
[Time Frame: 3 months]
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Secondary Outcome(s)
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pain interferences scores
[Time Frame: 3 months]
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QTc intervals
[Time Frame: 3 months]
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severity of adverse effects
[Time Frame: 3 months]
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Neuropathic pain score
[Time Frame: 3 months]
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Secondary ID(s)
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289/2554(EC4)
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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