Methadone in Post-Herpetic Neuralgia Pain

NCT ID: NCT01752699

Last Updated: 2013-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-01-31

Study Completion Date

2013-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Post-herpetic Neuralgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Methadone

in this arm patients will take methadone 5mg.

Group Type EXPERIMENTAL

Methadone

Intervention Type DRUG

patients with post-herpetic neuralgia take methadone or placebo to treat pain symptoms.

Placebo

in this arm patients will take placebo pills.

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

patients with post-herpetic neuralgia take placebo to treat the pain symptoms.

Interventions

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Methadone

patients with post-herpetic neuralgia take methadone or placebo to treat pain symptoms.

Intervention Type DRUG

Placebo

patients with post-herpetic neuralgia take placebo to treat the pain symptoms.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Daniel Ciampi Araujo de Andrade

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type DERIVED
PMID: 23917673 (View on PubMed)

Other Identifiers

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NPH

Identifier Type: -

Identifier Source: org_study_id

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