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

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. Identifier: NCT01557010
Recruitment Status : Completed
First Posted : March 19, 2012
Last Update Posted : February 21, 2014
Information provided by (Responsible Party):
Daewoong Pharmaceutical Co. LTD.

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

Condition or disease Intervention/treatment Phase
Postherpetic Neuralgia Drug: DWP05195 Drug: Control Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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
Study Start Date : March 2012
Actual Primary Completion Date : November 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shingles

Arm Intervention/treatment
Experimental: Treatment A Drug: DWP05195
Tablets, oral administration, 100mg

Experimental: Treatment B Drug: DWP05195
Tablets, oral administration, 200mg

Experimental: Treatment C Drug: DWP05195
Tablets, oral administration, 300mg

Placebo Comparator: Treatment D Drug: Control
Tablets, oral administration, Placebo

Primary Outcome Measures :
  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 ]

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Responsible Party: Daewoong Pharmaceutical Co. LTD. Identifier: NCT01557010     History of Changes
Other Study ID Numbers: DWP05195-P003
First Posted: March 19, 2012    Key Record Dates
Last Update Posted: February 21, 2014
Last Verified: February 2014

Additional relevant MeSH terms:
Neuralgia, Postherpetic
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms