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Completed

NCT Number: NCT01557010

Evaluate the Efficacy and Safety of DWP05195 in Subjects With Post-Herpetic Neuralgia

The purpose of this study is to evaluate efficacy, safety of administered DWP05195 in Postherpetic Neuralgia.

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Key information

Conditions

Postherpetic Neuralgia Nervous System Diseases Neuralgia Neuralgia, Postherpetic Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or Female subjects aged 20 to 80 years
  • Subjects with symptoms of neuropathic pain associated with postherpetic neuralgia(PHN).
  • Subjects must have pain present for > 3 months after healing of the acute herpes zoster skin rash.

Exclusion criteria

  • Other severe pain that may potentially confound pain assessment.
  • Subjects with symptoms of neuropathic pain applied Medical Equipment
  • Within 2 years: Subjects were diagnosed with cancer

Treatment and study plan

DWP05195

Drug

Tablets, oral administration, 100mg

Control

Drug

Tablets, oral administration, Placebo

Primary outcomes

  1. Endpoint change from the baseline after administered 8 weeks mean pain score based on the Numerical pain Rating Scale(NPRS) from the subject's daily pain diary

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Daewoong Pharmaceutical Co. LTD.

Industry

Registry information

Official study title

The Clinical Trial for Evaluation of Efficacy and Safety of DWP05195 in Postherpetic Neuralgia: Double-blind, Placebo-controlled, Randomized, Multi-center, Exploratory Clinical Trial

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 19, 2012
Registry last updated
Feb 21, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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