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OpenTrials
Completed

NCT Number: NCT02375633

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

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.

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Key information

Conditions

Chronic Back Pain

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DW-330SR2

Drug

Pelubiprofen

Drug

Primary outcomes

  1. The change of 100 mm Pain VAS

    Time frame: 28 days

Sponsors and collaborators

Lead sponsor

Daewon Pharmaceutical Co., Ltd.

Industry

Registry information

Important dates

Study start
2014
Primary completion
2014
First posted
Mar 2, 2015
Registry last updated
Oct 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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