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

Postherpetic Neuralgia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01557010
• Other study ID #: DWP05195-P003
• Status: Completed
• Phase: Phase 2
• First received: March 14, 2012
• Last updated: February 19, 2014
• Start date: March 2012
• Est. completion date: December 2013

Study information

• Verified date: February 2014
• Source: Daewoong Pharmaceutical Co. LTD.
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: December 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neuralgia
• Neuralgia, Postherpetic
• Postherpetic Neuralgia

Intervention

Drug:
• DWP05195
Tablets, oral administration, 100mg
• DWP05195
Tablets, oral administration, 200mg
• DWP05195
Tablets, oral administration, 300mg
• Control
Tablets, oral administration, Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Daewoong Pharmaceutical Co. LTD.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		8 weeks	No