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

October 14, 2014 updated by: Astellas Pharma Inc

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 --

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

616

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Chubu, Japan
      • Chugoku, Japan
      • Hokkaido, Japan
      • Kansai, Japan
      • Kantou, Japan
      • Kyusyu, Japan
      • Shikoku, Japan
      • Touhoku, Japan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo group
Drug: Placebo
oral
Experimental: YM177 group
Drug: YM177
oral
Other Names:
  • Celecoxib
  • Celecox
Active Comparator: etodolac group
Drug: etodolac
oral
Other Names:
  • Osteluc
  • Hypen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Patient impressions (4-categorical assessments)
Time Frame: For 2 days
For 2 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Pain intensity
Time Frame: For 2 days
For 2 days
Pain intensity difference
Time Frame: For 2 days
For 2 days
Discontinuation due to insufficient efficacy
Time Frame: For 2 days
For 2 days
Safety assessed by AE, clinical lab tests and vital signs
Time Frame: For 2 days
For 2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

May 5, 2010

First Submitted That Met QC Criteria

May 5, 2010

First Posted (Estimate)

May 6, 2010

Study Record Updates

Last Update Posted (Estimate)

October 15, 2014

Last Update Submitted That Met QC Criteria

October 14, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 177-CL-102

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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