Celecoxib Japan Observational Study for the Patients With... | NCT01876121

Studies
Celecoxib Japan Observational Study for the Patients With Acute Pain

NCT01876121

Sponsor

Astellas Pharma Inc

Status

Completed

Last Update Posted

Sep 5, 2014Estimated

Enrollment

784Actual

Phase

Not provided

Conditions

Patients With Traumatic Pain, Post-surgical Pain and Tooth Extract Pain

Interventions

Celecoxib

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

Sep 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

Jul 2012

Primary Completion Date

Apr 2013Actual

Completion Date

Apr 2013Actual

First Submitted Date

Jun 10, 2013

First Submission Date that Met QC Criteria

Jun 11, 2013

First Posted Date

Jun 12, 2013Estimated

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

Sep 4, 2014

Last Update Posted Date

Sep 5, 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

This study is to assess the safety and efficacy of celecoxib on the pain relief from acute pain.

Detailed Description

Patients with traumatic pain, post-surgical and tooth extract pain will be included in this study. Patients will receive Celecoxib for 2 weeks and the efficacy on pain relief and the safety will be evaluated.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

784Actual

Label	Type	Description	Intervention Names
Celecox group			Drug: Celecoxib

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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety assessed by the incidence of adverse events and lab-tests		For 2 weeks

Secondary Outcomes

Measure	Description	Time Frame
Overall pain improvement assessed by visual analogue scale (VAS)		Baseline and week-2

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with traumatic pain, post-surgical pain and tooth extract pain

Exclusion Criteria:

Hyperreactive to sulfonamide
Aspirin asthma patients
Peptidic ulcer patients
Serious liver disease patients
Serious kidney disease patients
Serious heart failure patients
End of pregnancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with traumatic pain, post-surgical pain and tooth extract pain

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Use Central Contact	Astellas Pharma Inc	Study Chair

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative
D059787	Acute Pain

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068579	Celecoxib

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
		Chūbu			Japan