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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02375633

Enrollment

166

Registered

2015-03-02

Start date

2014-04-30

Completion date

Unknown

Last updated

2016-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Back Pain

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.

Interventions

DRUGPelubiprofen

DRUGDW-330SR2

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
The change of 100 mm Pain VAS	28 days

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026