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

This study is not yet open for participant recruitment.

Verified March 2012 by Daewoong Pharmaceutical Co. LTD.

Sponsor:

Information provided by (Responsible Party):

Daewoong Pharmaceutical Co. LTD.

ClinicalTrials.gov Identifier:

NCT01557010

First received: March 14, 2012

Last updated: March 15, 2012

Last verified: March 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	March 14, 2012
Last Updated Date	March 15, 2012
Start Date ^ICMJE	March 2012
Estimated Primary Completion Date	February 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 15, 2012)	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 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01557010 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Evaluate the Efficacy and Safety of DWP05195 in Subjects With Post-Herpetic Neuralgia
Official Title ^ICMJE	The Clinical Trial for Evaluation of Efficacy and Safety of DWP05195 in Postherpetic Neuralgia: Double-blind, Placebo-controlled, Randomized, Multi-center, Exploratory Clinical Trial
Brief Summary	The purpose of this study is to evaluate efficacy, safety of administered DWP05195 in Postherpetic Neuralgia.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Postherpetic Neuralgia
Intervention ^ICMJE	Drug: DWP05195 Tablets, oral administration, 100mg Drug: DWP05195 Tablets, oral administration, 200mg Drug: DWP05195 Tablets, oral administration, 300mg Drug: Control Tablets, oral administration, Placebo
Study Arm (s)	Experimental: Treatment A Intervention: Drug: DWP05195 Experimental: Treatment B Intervention: Drug: DWP05195 Experimental: Treatment C Intervention: Drug: DWP05195 Placebo Comparator: Treatment D Intervention: Drug: Control
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Not yet recruiting
Estimated Enrollment ^ICMJE	140
Completion Date	Not Provided
Estimated Primary Completion Date	February 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	20 Years to 80 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01557010
Other Study ID Numbers ^ICMJE	DWP05195-P003
Has Data Monitoring Committee	Not Provided
Responsible Party	Daewoong Pharmaceutical Co. LTD.
Study Sponsor ^ICMJE	Daewoong Pharmaceutical Co. LTD.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Daewoong Pharmaceutical Co. LTD.
Verification Date	March 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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