Dexketoprofen and Etoricoxib in Patients Undergoing Hip A... | NCT02568735

Studies
Dexketoprofen and Etoricoxib in Patients Undergoing Hip Arthroplasty

NCT02568735

Sponsor

Kuopio University Hospital

Status

Completed

Last Update Posted

May 3, 2016Estimated

Enrollment

24Actual

Phase

Phase 4

Conditions

Pain, Postoperative

Interventions

Dexketoprofen
Etoricoxib

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2016

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

Jan 2013

Primary Completion Date

Dec 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

Oct 5, 2015

First Submission Date that Met QC Criteria

Oct 5, 2015

First Posted Date

Oct 6, 2015Estimated

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

Apr 30, 2016

Last Update Posted Date

May 3, 2016Estimated

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 main purpose of this study was to determine the plasma and central nervious system pharmacokinetics of dexketoprofen and etoricoxib. The secondary aim was to asses their effect on the concentrations of interleukin 6, prostaglandin E2 and other proinflammatory markers both in plasma and cerebrospinal fluid. Thirdly, the investigators aimed to evaluate their efficacy in postoperative pain treatment.

Detailed Description

Not provided

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

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Etoricoxib	Experimental	Etoricoxib 60mg if body weight≤ 60kg, 90mg if body weight 61-90kg and 120mg if body weight> 90kg by mouth	Drug: Etoricoxib
Dexketoprofen	Active Comparator	Dexketoprofen 0,5 mg/kg up to 50 mg intravenously	Drug: Dexketoprofen

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dexketoprofen	Drug	After total hip replacement surgery patient were given either etoricoxib or dexketoprofen	Dexketoprofen

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cerebrospinal fluid concentration dexketoprofen and etoricoxib	Cerebrospinal fluid concentration of dexketoprofen and etoricoxib	0-24 hours
Plasma concentration dexketoprofen and etoricoxib	Plasma concentration dexketoprofen and etoricoxib	0-24 hours

Secondary Outcomes

Measure	Description	Time Frame
Pain	Pain assessed with numeral rating scale	0-24 h

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

agreed to participate the study
American Society of Anesthesiologist s physical status classification 1-3
elective hip arthroplasty planned
no contraindications to the study drugs
no contraindication to lumbar puncture

Exclusion Criteria:

refused to participate the study
age less than 40 or over 75 years
Planned anesthesia method other than spinal anesthesia
contraindications to the study drugs
Contraindications to lumbar puncture

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Date	Date Unknown
Release	Apr 11, 2017
Reset	May 15, 2017
Release	Dec 29, 2022
Reset	Jan 24, 2023
Release	Mar 14, 2023
Reset	Apr 6, 2023

Submission Tracking

Estimated Results First Submitted Date

Apr 11, 2017

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Apr 11, 2017			May 15, 2017
Dec 29, 2022

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
C118296	dexketoprofen trometamol
D000077613	Etoricoxib

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided