Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03221907
Other study ID # DW1502-301
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date April 11, 2016
Est. completion date January 8, 2019

Study information

Verified date March 2019
Source Daewon Pharmaceutical Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A multi-center, randomized, double-blind, parallel, active-controlled phase III clinical trial to evaluate the efficacy and safety of 'GLA5PR GLARS-NF1 Tab.' and 'Pregabalin' in peripheral neuropathic pain


Recruitment information / eligibility

Status Completed
Enrollment 352
Est. completion date January 8, 2019
Est. primary completion date January 8, 2019
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria:

- both male and female who are over 19-year-old

- patient whose pain scale is 4~9

- patient who has pain of mononeuropathy

Exclusion Criteria:

- patient whose CCr is <60ml/min

- patient who has other pain which is not from mononeuropathy

- patient who is going to have an operation during this study

- patient who has abnormal ECG

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
GLA5PR GLARS-NF1
Pregabalin tablet
GLA5PR GLARS-NF1 placebo
tablet manufactured to mimic GLA5PR GLARS-NF1
Pregabalin
Pregabalin capsule
Pregabalin placebo
tablet manufactured to mimic pregabalin capsule

Locations

Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Daewon Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Daily Pain Rating Scale 12-week