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

Chronic Back Pain Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02375633
• Other study ID #: DW-330SR2_301
• Status: Completed
• Phase: Phase 3
• First received: February 24, 2015
• Last updated: October 7, 2016
• Start date: April 2014

Study information

• Verified date: October 2016
• Source: Daewon Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 166
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Chronic Back Pain

Intervention

Drug:
• DW-330SR2

• Pelubiprofen

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Daewon Pharmaceutical Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change of 100 mm Pain VAS		28 days	No