NCT02375633

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
166

participants targeted

Target at P25-P50 for phase_3

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

April 1, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 2, 2015

Completed
Last Updated

October 10, 2016

Status Verified

October 1, 2016

Enrollment Period

7 months

First QC Date

February 24, 2015

Last Update Submit

October 7, 2016

Conditions

Chronic Back Pain

Outcome Measures

Primary Outcomes (1)

  • The change of 100 mm Pain VAS

    28 days

Study Arms (2)

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

DW-330SR2DRUG
DW-330SR2
PelubiprofenDRUG
Pelubiprofen

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

pelubiprofen

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2015

First Posted

March 2, 2015

Study Start

April 1, 2014

Primary Completion

November 1, 2014

Last Updated

October 10, 2016

Record last verified: 2016-10