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Methadone in Post-Herpetic Neuralgia Pain (NPH)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Daniel Ciampi Araujo de Andrade, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01752699
First received: December 11, 2012
Last updated: March 14, 2013
Last verified: March 2013
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Methadone in Post-Herpetic Neuralgia Pain

Resource links provided by NLM:

MedlinePlus related topics: Shingles
U.S. FDA Resources

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Change in baseline Pain [ Time Frame: baseline (visit inclusion) and three moths latter ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

No publications provided

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
Study First Received: December 11, 2012
Last Updated: March 14, 2013
Health Authority: Brazil: Ethics Committee

Keywords provided by 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
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents
Narcotics

ClinicalTrials.gov processed this record on May 16, 2013