A Study to Verify the Efficacy of YM177 (Celecoxib) in Postoperative Pain Patients
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 --
1 other identifier
interventional
616
1 country
8
Brief Summary
Aim of the study is to compare efficacy and safety of YM177 with placebo and etodolac in patients with postoperative pain.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2010
Shorter than P25 for phase_3
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 5, 2010
CompletedFirst Posted
Study publicly available on registry
May 6, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedOctober 15, 2014
October 1, 2014
9 months
May 5, 2010
October 14, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Patient impressions (4-categorical assessments)
For 2 days
Secondary Outcomes (4)
Pain intensity
For 2 days
Pain intensity difference
For 2 days
Discontinuation due to insufficient efficacy
For 2 days
Safety assessed by AE, clinical lab tests and vital signs
For 2 days
Study Arms (3)
YM177 group
EXPERIMENTALetodolac group
ACTIVE COMPARATORplacebo group
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Patients with spontaneous pain within 24 hours postoperatively
- The intensity of the pain:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Unknown Facility
Chugoku, Japan
Unknown Facility
Chūbu, Japan
Unknown Facility
Hokkaido, Japan
Unknown Facility
Kansai, Japan
Unknown Facility
Kantou, Japan
Unknown Facility
Kyusyu, Japan
Unknown Facility
Shikoku, Japan
Unknown Facility
Tōhoku, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Use Central Contact
Astellas Pharma Inc
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 5, 2010
First Posted
May 6, 2010
Study Start
February 1, 2010
Primary Completion
November 1, 2010
Study Completion
November 1, 2010
Last Updated
October 15, 2014
Record last verified: 2014-10