This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been completed.
Information provided by (Responsible Party):
Astellas Pharma Inc Identifier:
First received: May 5, 2010
Last updated: October 14, 2014
Last verified: October 2014
Aim of the study is to compare efficacy and safety of YM177 with placebo and etodolac in patients with postoperative pain.

Condition Intervention Phase
Post Operative Pain Drug: YM177 Drug: etodolac Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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 --

Resource links provided by NLM:

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Patient impressions (4-categorical assessments) [ Time Frame: For 2 days ]

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

Enrollment: 616
Study Start Date: February 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: YM177 group Drug: YM177
Other Names:
  • Celecoxib
  • Celecox
Active Comparator: etodolac group Drug: etodolac
Other Names:
  • Osteluc
  • Hypen
Placebo Comparator: placebo group Drug: Placebo

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.

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01118572

Chubu, Japan
Chugoku, Japan
Hokkaido, Japan
Kansai, Japan
Kantou, Japan
Kyusyu, Japan
Shikoku, Japan
Touhoku, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Study Chair: Use Central Contact Astellas Pharma Inc
  More Information

Additional Information:
Responsible Party: Astellas Pharma Inc Identifier: NCT01118572     History of Changes
Other Study ID Numbers: 177-CL-102
Study First Received: May 5, 2010
Last Updated: October 14, 2014

Keywords provided by Astellas Pharma Inc:

Additional relevant MeSH terms:
Pain, Postoperative
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents processed this record on July 26, 2017