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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01118572
Recruitment Status : Completed
First Posted : May 6, 2010
Last Update Posted : October 15, 2014
Information provided by (Responsible Party):
Astellas Pharma Inc

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

Condition or disease Intervention/treatment Phase
Post Operative Pain Drug: YM177 Drug: etodolac Drug: Placebo Phase 3

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  (Clinical Trial)
Actual Enrollment : 616 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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 --
Study Start Date : February 2010
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

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

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Additional Information:
Responsible Party: Astellas Pharma Inc Identifier: NCT01118572     History of Changes
Other Study ID Numbers: 177-CL-102
First Posted: May 6, 2010    Key Record Dates
Last Update Posted: October 15, 2014
Last Verified: October 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