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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01752699
Other study ID # NPH
Secondary ID
Status Completed
Phase Phase 3
First received December 11, 2012
Last updated March 14, 2013
Start date January 1998
Est. completion date March 2013

Study information

Verified date March 2013
Source University of Sao Paulo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date March 2013
Est. primary completion date February 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Drug:
Methadone
patients with post-herpetic neuralgia take methadone or placebo to treat pain symptoms.
Placebo
patients with post-herpetic neuralgia take placebo to treat the pain symptoms.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Sao Paulo

Outcome

Type Measure Description Time frame Safety issue
Primary Change in baseline Pain Assessing by verbal analog scale (VAS) baseline (visit inclusion) and three moths latter
See also
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Terminated NCT03094195 - Dose Response Study of EMA401 in Patients With Post-herpetic Neuralgia (PHN) Phase 2
Completed NCT02318719 - DS-5565 Phase III Study for Post-herpetic Neuralgia N/A
Completed NCT01250561 - Reduction of Postherpetic Neuralgia in Herpes Zoster N/A
Completed NCT02607280 - DS-5565 Phase III Study for Renal Impairment in Japanese Subjects Phase 3
Completed NCT01037088 - Effects of Vaporized Marijuana on Neuropathic Pain Phase 1/Phase 2
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Recruiting NCT05593237 - Transcranial Magnetic Stimulation for Chronic Neuropathic Pain N/A
Completed NCT01848730 - Efficacy and Safety of CNV2197944 Versus Placebo in Patients With Post-herpetic Neuralgia Phase 2