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

NCT ID: NCT02375633

Last Updated: 2016-10-10

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

PHASE3

Total Enrollment

166 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Brief Summary

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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

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Conditions

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Chronic Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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DW-330SR2

DW-330SR(Pelubiprofen) 45mg twice a day

Group Type EXPERIMENTAL

DW-330SR2

Intervention Type DRUG

Pelubiprofen

Active Comparator(Pelubiprofen) 30mg three times a day

Group Type ACTIVE_COMPARATOR

Pelubiprofen

Intervention Type DRUG

Interventions

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DW-330SR2

Intervention Type DRUG

Pelubiprofen

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Daewon Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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DW-330SR2_301

Identifier Type: -

Identifier Source: org_study_id

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