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Methadone in Post-Herpetic Neuralgia Pain (NPH)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01752699
First Posted: December 19, 2012
Last Update Posted: March 18, 2013
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.
Information provided by (Responsible Party):
Daniel Ciampi Araujo de Andrade, University of Sao Paulo
  Purpose
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.

Condition Intervention Phase
Post-herpetic Neuralgia Drug: Methadone Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Methadone in Post-Herpetic Neuralgia Pain

Resource links provided by NLM:


Further study details as provided by Daniel Ciampi Araujo de Andrade, University of Sao Paulo:

Primary Outcome Measures:
  • Change in baseline Pain [ Time Frame: baseline (visit inclusion) and three moths latter ]
    Assessing by verbal analog scale (VAS)


Enrollment: 10
Study Start Date: January 1998
Study Completion Date: March 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Methadone
in this arm patients will take methadone 5mg.
Drug: Methadone
patients with post-herpetic neuralgia take methadone or placebo to treat pain symptoms.
Experimental: Placebo
in this arm patients will take placebo pills.
Drug: Placebo
patients with post-herpetic neuralgia take placebo to treat the pain symptoms.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Daniel Ciampi Araujo de Andrade, MD, PhD, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01752699     History of Changes
Other Study ID Numbers: NPH
First Submitted: December 11, 2012
First Posted: December 19, 2012
Last Update Posted: March 18, 2013
Last Verified: March 2013

Keywords provided by Daniel Ciampi Araujo de Andrade, University of Sao Paulo:
neuropathic pain,
post-herpetic neuralgia,
methadone,

Additional relevant MeSH terms:
Neuralgia
Neuralgia, Postherpetic
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
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