Phase 3 Study of DW-330SR2 and Pelubiprofen in Chronic Ba... | NCT02375633

Studies
Phase 3 Study of DW-330SR2 and Pelubiprofen in Chronic Back Pain Patients

NCT02375633

Sponsor

Daewon Pharmaceutical Co., Ltd.

Status

Completed

Last Update Posted

Oct 10, 2016Estimated

Enrollment

166Actual

Phase

Phase 3

Conditions

Chronic Back Pain

Interventions

DW-330SR2
Pelubiprofen

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2014

Primary Completion Date

Nov 2014Actual

Completion Date

Not provided

First Submitted Date

Feb 24, 2015

First Submission Date that Met QC Criteria

Feb 27, 2015

First Posted Date

Mar 2, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 7, 2016

Last Update Posted Date

Oct 10, 2016Estimated

Description Module

Brief Summary

A Multicenter, Randomized, Double-blinded, Parallel, Active-controlled, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DW-330SR2 and Pelubiprofen in Chronic Back Pain Patients.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

166Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
DW-330SR2	Experimental	DW-330SR(Pelubiprofen) 45mg twice a day	Drug: DW-330SR2
Pelubiprofen	Active Comparator	Active Comparator(Pelubiprofen) 30mg three times a day	Drug: Pelubiprofen

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DW-330SR2	Drug		DW-330SR2
Pelubiprofen

Measure	Description	Time Frame
The change of 100 mm Pain VAS		28 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

More than 12 weeks by the time the trial started , and low back pain that requires analgesia administration.
Class 1 or 2 back pain patients along Quebec Task Force Classification
Patients with pain at least 40mm test results at visit2
The voluntary or legal guardian 's written consent to participate in this clinical trial subjects

Exclusion Criteria:

Severe gastrointestinal disease, heart disease, high blood pressure patients
Patients with secondary causes are obvious
Within 24 weeks patient who has back surgery before clinical trial participation
Within 4 weeks patient who experienced psychotropic drugs, a narcotic analgesic dosage that may affect the pain sensation
Within 4 weeks patient who treated steroid drug by oral or injection
Within 2 weeks patient who treated MAO inhibition drugs
Patients with severe respiratory depression status

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided