Back to resultsA Study to Verify the Efficacy of YM177 (Celecoxib) in Postoperative Pain Patients
Primary Purpose
Post Operative Pain
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
YM177
etodolac
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Post Operative Pain focused on measuring Celecoxib, Celecox, Pain, Surgery, NSAIDs
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
YM177 group
etodolac group
placebo group
Arm Description
Outcomes
Primary Outcome Measures
Patient impressions (4-categorical assessments)
Secondary Outcome Measures
Pain intensity
Pain intensity difference
Discontinuation due to insufficient efficacy
Safety assessed by AE, clinical lab tests and vital signs
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01118572
Brief Title
A Study to Verify the Efficacy of YM177 (Celecoxib) in Postoperative Pain Patients
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 Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Aim of the study is to compare efficacy and safety of YM177 with placebo and etodolac in patients with postoperative pain.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain
Keywords
Celecoxib, Celecox, Pain, Surgery, NSAIDs
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
616 (Actual)
8. Arms, Groups, and Interventions
Arm Title
YM177 group
Arm Type
Experimental
Arm Title
etodolac group
Arm Type
Active Comparator
Arm Title
placebo group
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
YM177
Other Intervention Name(s)
Celecoxib, Celecox
Intervention Description
oral
Intervention Type
Drug
Intervention Name(s)
etodolac
Other Intervention Name(s)
Osteluc, Hypen
Intervention Description
oral
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
oral
Primary Outcome Measure Information:
Title
Patient impressions (4-categorical assessments)
Time Frame
For 2 days
Secondary Outcome Measure Information:
Title
Pain intensity
Time Frame
For 2 days
Title
Pain intensity difference
Time Frame
For 2 days
Title
Discontinuation due to insufficient efficacy
Time Frame
For 2 days
Title
Safety assessed by AE, clinical lab tests and vital signs
Time Frame
For 2 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Organizational Affiliation
Astellas Pharma Inc
Official's Role
Study Chair
Facility Information:
City
Chubu
Country
Japan
City
Chugoku
Country
Japan
City
Hokkaido
Country
Japan
City
Kansai
Country
Japan
City
Kantou
Country
Japan
City
Kyusyu
Country
Japan
City
Shikoku
Country
Japan
City
Touhoku
Country
Japan
12. IPD Sharing Statement
Links:
URL
http://www.clinicaltrials.jp/user/ctrSearch.jsp
Description
Link to Results on JAPIC - enter 140636 in the JapicCTI-RNo. field (Japanese record)
Learn more about this trial
A Study to Verify the Efficacy of YM177 (Celecoxib) in Postoperative Pain Patients
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