A Study to Verify the Efficacy of YM177 (Celecoxib) in Po... | NCT01118572

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

NCT01118572

Sponsor

Astellas Pharma Inc

Status

Completed

Last Update Posted

Oct 15, 2014Estimated

Enrollment

616Actual

Phase

Phase 3

Conditions

Post Operative Pain

Interventions

YM177
etodolac
Placebo

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2010

Primary Completion Date

Nov 2010Actual

Completion Date

Nov 2010Actual

First Submitted Date

May 5, 2010

First Submission Date that Met QC Criteria

May 5, 2010

First Posted Date

May 6, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 14, 2014

Last Update Posted Date

Oct 15, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

616Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
YM177 group	Experimental	Drug: YM177
etodolac group	Active Comparator	Drug: etodolac
placebo group	Placebo Comparator	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
YM177	Drug	oral	YM177 group	Celecoxib Celecox

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Patient impressions (4-categorical assessments)		For 2 days

Secondary Outcomes

Measure	Description	Time Frame
Pain intensity		For 2 days
Pain intensity difference		For 2 days
Discontinuation due to insufficient efficacy

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Use Central Contact	Astellas Pharma Inc	Study Chair

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative
D010146	Pain

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D009461	Neurologic Manifestations

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068579	Celecoxib
D017308	Etodolac

Ancestor Terms

ID	Term
D000096926	Benzenesulfonamides
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
		Chugoku			Japan