Evaluate the Efficacy and Safety of DWP05195 in Subjects With Post-Herpetic Neuralgia
This study is not yet open for participant recruitment.
Verified March 2012 by Daewoong Pharmaceutical Co. LTD.
Sponsor:
Daewoong Pharmaceutical Co. LTD.
Information provided by (Responsible Party):
Daewoong Pharmaceutical Co. LTD.
ClinicalTrials.gov Identifier:
NCT01557010
First received: March 14, 2012
Last updated: March 15, 2012
Last verified: March 2012
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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 ]
| Estimated Enrollment: | 140 |
| Study Start Date: | March 2012 |
| Estimated Primary Completion Date: | February 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: | March 15, 2012 |
| 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 May 16, 2013