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

This study has been completed.
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01118572
First received: May 5, 2010
Last updated: January 5, 2011
Last verified: January 2011
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Patient impressions (4-categorical assessments) [ Time Frame: For 2 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain intensity [ Time Frame: For 2 days ] [ Designated as safety issue: No ]
  • Pain intensity difference [ Time Frame: For 2 days ] [ Designated as safety issue: No ]
  • Discontinuation due to insufficient efficacy [ Time Frame: For 2 days ] [ Designated as safety issue: No ]
  • Safety assessed by AE, clinical lab tests and vital signs [ Time Frame: For 2 days ] [ Designated as safety issue: No ]

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
oral
Other Names:
  • Celecoxib
  • Celecox
Active Comparator: etodolac group Drug: etodolac
oral
Other Names:
  • Osteluc
  • Hypen
Placebo Comparator: placebo group Drug: Placebo
oral

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01118572

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

No publications provided

Responsible Party: Director, Astellas Pharma, Inc
ClinicalTrials.gov Identifier: NCT01118572     History of Changes
Other Study ID Numbers: 177-CL-102
Study First Received: May 5, 2010
Last Updated: January 5, 2011
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Astellas Pharma Inc:
Celecoxib
Celecox
Pain
Surgery
NSAIDs

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Etodolac
Celecoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Central Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 23, 2013