Methadone in Post-Herpetic Neuralgia Pain (NPH)
Primary Purpose
Post-herpetic Neuralgia
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Methadone
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Post-herpetic Neuralgia focused on measuring neuropathic pain,, post-herpetic neuralgia,, methadone,
Eligibility Criteria
Inclusion Criteria:
- Patients with chronic (>6 months) symptomatic PHN
- with visual analogical scale >40/100mm
- use of first and second line drugs (tricyclic antidepressants, venlafaxine and gabapentinoids)
Exclusion Criteria:
- Don't full the criteria above
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Methadone
Placebo
Arm Description
in this arm patients will take methadone 5mg.
in this arm patients will take placebo pills.
Outcomes
Primary Outcome Measures
Change in baseline Pain
Assessing by verbal analog scale (VAS)
Secondary Outcome Measures
Full Information
NCT ID
NCT01752699
First Posted
December 11, 2012
Last Updated
March 14, 2013
Sponsor
University of Sao Paulo
1. Study Identification
Unique Protocol Identification Number
NCT01752699
Brief Title
Methadone in Post-Herpetic Neuralgia Pain
Acronym
NPH
Official Title
Methadone in Post-Herpetic Neuralgia Pain
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
January 1998 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Neuropathic pain is a common condition and affecting 40 to 70% of the general population. Post-herpetic neuralgia is a condition almost complex and requires a multi modal treatment. Aim: This is a pilot proof-of-principle study designed to evaluate the use of low-dose methadone in post-herpetic neuralgia patients who remained refractory after first and second line treatment for post-herpetic neuralgia (PHN) and had indication for the association of an opioid agent to their current drug regimen.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-herpetic Neuralgia
Keywords
neuropathic pain,, post-herpetic neuralgia,, methadone,
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Methadone
Arm Type
Experimental
Arm Description
in this arm patients will take methadone 5mg.
Arm Title
Placebo
Arm Type
Experimental
Arm Description
in this arm patients will take placebo pills.
Intervention Type
Drug
Intervention Name(s)
Methadone
Intervention Description
patients with post-herpetic neuralgia take methadone or placebo to treat pain symptoms.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
patients with post-herpetic neuralgia take placebo to treat the pain symptoms.
Primary Outcome Measure Information:
Title
Change in baseline Pain
Description
Assessing by verbal analog scale (VAS)
Time Frame
baseline (visit inclusion) and three moths latter
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with chronic (>6 months) symptomatic PHN
with visual analogical scale >40/100mm
use of first and second line drugs (tricyclic antidepressants, venlafaxine and gabapentinoids)
Exclusion Criteria:
Don't full the criteria above
12. IPD Sharing Statement
Citations:
PubMed Identifier
23917673
Citation
Teixeira MJ, Okada M, Moscoso AS, Puerta MY, Yeng LT, Galhardoni R, Tengan S, Andrade DC. Methadone in post-herpetic neuralgia: A pilot proof-of-concept study. Clinics (Sao Paulo). 2013 Jul;68(7):1057-60. doi: 10.6061/clinics/2013(07)25.
Results Reference
derived
Learn more about this trial
Methadone in Post-Herpetic Neuralgia Pain
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