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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Daewoong Pharmaceutical Co. LTD.
ClinicalTrials.gov Identifier:
NCT01557010
First received: March 14, 2012
Last updated: February 19, 2014
Last verified: February 2014

March 14, 2012
February 19, 2014
March 2012
November 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01557010 on ClinicalTrials.gov Archive Site
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Evaluate the Efficacy and Safety of DWP05195 in Subjects With Post-Herpetic Neuralgia
The Clinical Trial for Evaluation of Efficacy and Safety of DWP05195 in Postherpetic Neuralgia: Double-blind, Placebo-controlled, Randomized, Multi-center, Exploratory Clinical Trial

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Postherpetic Neuralgia
  • Drug: DWP05195
    Tablets, oral administration, 100mg
  • Drug: DWP05195
    Tablets, oral administration, 200mg
  • Drug: DWP05195
    Tablets, oral administration, 300mg
  • Drug: Control
    Tablets, oral administration, Placebo
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
140
December 2013
November 2013   (final data collection date for primary outcome measure)

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
Both
20 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01557010
DWP05195-P003
Not Provided
Daewoong Pharmaceutical Co. LTD.
Daewoong Pharmaceutical Co. LTD.
Not Provided
Not Provided
Daewoong Pharmaceutical Co. LTD.
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP