A Study Comparing Etoricoxib and Diclofenac Sodium in Pos... | NCT01190722

Studies
A Study Comparing Etoricoxib and Diclofenac Sodium in Post Hallux Valgus Surgery Pain

NCT01190722

Sponsor

Karolinska Institutet

Status

Withdrawn

Last Update Posted

Dec 2, 2017Actual

Enrollment

0Actual

Phase

Phase 4

Conditions

Hallux Valgus
Postoperative Pain

Interventions

etoricoxib
Diclofenac

Countries

Not provided

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

Nov 2017

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The study site was closed down

Expanded Access Info

Start Date

Nov 10, 2010Actual

Primary Completion Date

Dec 11, 2010Actual

Completion Date

Dec 12, 2010Actual

First Submitted Date

Aug 27, 2010

First Submission Date that Met QC Criteria

Aug 27, 2010

First Posted Date

Aug 30, 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

Nov 29, 2017

Last Update Posted Date

Dec 2, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The investigators hypothesize that cyclooxygenas-II-selective inhibitors (Coxibs) provide a better patients assessed overall satisfaction when used for pain management after elective hallux valgus surgery as compared to traditional Non-steroidal anti-inflammatory drugs (NSAIDs).

Detailed Description

The aim of the present study is to compare patients' satisfaction with pain medication during the first 7 first postoperative days following elective hallux valgus surgery in general anaesthesia between etoricoxib and diclofenac in a prospective randomised double-blind study design.

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
etoricoxib	Experimental	active study drug, coxib	Drug: etoricoxib
diclofenac	Active Comparator	active traditional NSAID control	Drug: Diclofenac

Interventions

Name	Type	Description	Arm Group Labels	Other Names
etoricoxib	Drug	120 mg once daily for the 1st 6 postoperative days	etoricoxib

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Patients Global Evaluation of Study Medication	Patients self-assessment of global satisfaction with pain medication	postoperative day 1-6

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

American Society of Anesthesiology (ASA) physiological class 1-2 patients
aged 18-65 years
scheduled for elective hallux valgus surgery in general anesthesia

Exclusion Criteria:

NSAID allergy
liver disease
renal disease
uncontrolled cardiovascular disease
Lithium therapy
chronic pain
regular analgesia use

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jan Jakobsson, Professor	Karolinska Institutet	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006215	Hallux Valgus
D010149	Pain, Postoperative

Ancestor Terms

ID	Term
D005530	Foot Deformities
D009140	Musculoskeletal Diseases
D011183	Postoperative Complications
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077613	Etoricoxib
D004008	Diclofenac

Ancestor Terms

ID	Term
D013450	Sulfones
D013457	Sulfur Compounds
D009930	Organic Chemicals
D011725	Pyridines

Browse Leaves

Not provided

Browse Branches

Not provided