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

Daewon Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Chronic Back Pain

Treatments: Drug: Pelubiprofen; Drug: DW-330SR2

Study type: Interventional

Funder types: Industry

Identifiers

NCT02375633

DW-330SR2_301

Details and patient eligibility

About

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.

Enrollment: 166 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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166 participants in 2 patient groups

DW-330SR2

Experimental group

Description:

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

Treatment:

Drug: DW-330SR2

Pelubiprofen

Active Comparator group

Description:

Active Comparator(Pelubiprofen) 30mg three times a day

Treatment:

Drug: Pelubiprofen