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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daewon Pharmaceutical Co., Ltd.

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