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

NCT ID: NCT01557010

Last Updated: 2014-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2013-12-31

Brief Summary

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

Detailed Description

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Conditions

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Postherpetic Neuralgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Treatment A

Group Type EXPERIMENTAL

DWP05195

Intervention Type DRUG

Tablets, oral administration, 100mg

Treatment B

Group Type EXPERIMENTAL

DWP05195

Intervention Type DRUG

Tablets, oral administration, 200mg

Treatment C

Group Type EXPERIMENTAL

DWP05195

Intervention Type DRUG

Tablets, oral administration, 300mg

Treatment D

Group Type PLACEBO_COMPARATOR

Control

Intervention Type DRUG

Tablets, oral administration, Placebo

Interventions

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DWP05195

Tablets, oral administration, 100mg

Intervention Type DRUG

DWP05195

Tablets, oral administration, 200mg

Intervention Type DRUG

DWP05195

Tablets, oral administration, 300mg

Intervention Type DRUG

Control

Tablets, oral administration, Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Daewoong Pharmaceutical Co. LTD.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

References

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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.

Reference Type DERIVED
PMID: 36729473 (View on PubMed)

Other Identifiers

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DWP05195-P003

Identifier Type: -

Identifier Source: org_study_id

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