NCT01557010

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2012

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

March 14, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 19, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

February 21, 2014

Status Verified

February 1, 2014

Enrollment Period

1.7 years

First QC Date

March 14, 2012

Last Update Submit

February 19, 2014

Conditions

Postherpetic Neuralgia

Outcome Measures

Primary Outcomes (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

    8 weeks

Study Arms (4)

Treatment A

EXPERIMENTAL
Drug: DWP05195

Treatment B

EXPERIMENTAL
Drug: DWP05195

Treatment C

EXPERIMENTAL
Drug: DWP05195

Treatment D

PLACEBO COMPARATOR
Drug: Control

Interventions

DWP05195DRUG

Tablets, oral administration, 100mg

Treatment A
ControlDRUG

Tablets, oral administration, Placebo

Treatment D

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Mangwani-Mordani S, Goodman CF, Galor A. Novel Treatments for Chronic Ocular Surface Pain. Cornea. 2023 Mar 1;42(3):261-271. doi: 10.1097/ICO.0000000000003193. Epub 2022 Dec 19.

    PMID: 36729473DERIVED

MeSH Terms

Conditions

Neuralgia, Postherpetic

Condition Hierarchy (Ancestors)

NeuralgiaPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2012

First Posted

March 19, 2012

Study Start

March 1, 2012

Primary Completion

November 1, 2013

Study Completion

December 1, 2013

Last Updated

February 21, 2014

Record last verified: 2014-02