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
  Purpose

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


Condition Intervention Phase
Postherpetic Neuralgia
Drug: DWP05195
Drug: Control
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Daewoong Pharmaceutical Co. LTD.:

Primary Outcome Measures:
  • 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 ]

Enrollment: 140
Study Start Date: March 2012
Study Completion Date: December 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Daewoong Pharmaceutical Co. LTD.
ClinicalTrials.gov Identifier: NCT01557010     History of Changes
Other Study ID Numbers: DWP05195-P003
Study First Received: March 14, 2012
Last Updated: February 19, 2014
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

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

ClinicalTrials.gov processed this record on April 22, 2014