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NCT Number: NCT01118572

A Study to Verify the Efficacy of YM177 (Celecoxib) in Postoperative Pain Patients

Aim of the study is to compare efficacy and safety of YM177 with placebo and etodolac in patients with postoperative pain.

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Key information

Conditions

Post Operative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Chugoku, Japan

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About this study

To verify the superiority to placebo and the noninferiority to etodolac of YM177 in terms of efficacy assessment in patients with postoperative pain. Also, to compare them in terms of safety assessment.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with spontaneous pain within 24 hours postoperatively
  • The intensity of the pain:
  • 4-categorical assessment: "Moderate pain" or "Severe pain"
  • VAS assessment: 45.0 mm or higher
  • Patients whose postoperative pain can be managed using an oral NSAID

Exclusion criteria

  • A past history of aspirin-induced asthma
  • A past of ischemic heart disease, serious arrhythmia, congestive heart failure or cerebrovascular disease
  • Patients who undergoes the surgical procedure under general anesthesia
  • Patients taking excluded medications

Treatment and study plan

YM177

Drug

oral

Other names: Celecoxib, Celecox

Etodolac

Drug

oral

Other names: Osteluc, Hypen

Placebo

Drug

oral

Primary outcomes

  1. Patient impressions (4-categorical assessments)

    Time frame: For 2 days

Secondary outcomes

  1. Pain intensity

    Time frame: For 2 days

  2. Pain intensity difference

    Time frame: For 2 days

  3. Discontinuation due to insufficient efficacy

    Time frame: For 2 days

  4. Safety assessed by AE, clinical lab tests and vital signs

    Time frame: For 2 days

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study title

A Phase III Study of YM177 (Postoperative Pain) -- An Etodolac- and Placebo-controlled, Multicenter, Double-blind, Group Comparison Study to Verify the Efficacy of YM177 (Celecoxib) in Postoperative Pain Patients --

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
May 6, 2010
Registry last updated
Oct 15, 2014

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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