Parecoxib vs Paracetamol in the Treatment of Acute Renal... | NCT03704623

Studies
Parecoxib vs Paracetamol in the Treatment of Acute Renal Colic

NCT03704623

Sponsor

Mansoura University

Status

Completed

Last Update Posted

Aug 28, 2020Actual

Enrollment

200Actual

Phase

Phase 4

Conditions

Acute Renal Colic
Ureteric Stone

Interventions

Paracetamol
Parecoxib

Countries

Kuwait

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

Aug 2020

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

May 1, 2019Actual

Primary Completion Date

Aug 15, 2020Actual

Completion Date

Aug 15, 2020Actual

First Submitted Date

Oct 10, 2018

First Submission Date that Met QC Criteria

Oct 12, 2018

First Posted Date

Oct 15, 2018Actual

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

Aug 26, 2020

Last Update Posted Date

Aug 28, 2020Actual

Name	Class
Amiri Hospital	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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 will be conducted to compare the efficacy and safety of Parecoxib versus Paracetamol for treatment of acute renal colic due to ureteric stones.

Detailed Description

Eligible patients will be randomized to one of the two treatment groups. Group 1 patients will receive IV 1 g of Paracetamol while group 2 patients will receive 40 mg of Parecoxib IV.

The Visual Analogue Scale (VAS) will be calculated on presentation and at 30 minutes after analgesia administration. Patients who do not respond to an initial dose of the analgesia will receive rescue analgesia in the form of Morphine, 01.mg/kg, IV.

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

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Paracetamol	Active Comparator	Patients will receive IV 1 g of Paracetamol	Drug: Paracetamol
Parecoxib	Active Comparator	Patients will receive 40 mg of Parecoxib IV	Drug: Parecoxib

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Paracetamol	Drug	Paracetamol 1g IV	Paracetamol	Perfalgan

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The need for rescue analgesia (Morphine)	Patient who had persistent pain	30 minutes

Secondary Outcomes

Measure	Description	Time Frame
The incidence of adverse effects due to medication used	Assessment of adverse effects of the drug used	24 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical signs and symptoms consistent with acute renal colic

Exclusion Criteria:

Hypersensitivity to either Paracetamol or Parecoxib.
History of peptic ulcer.
Pregnant or breastfeeding females.
Patients with hepatic impairment (Child-Pugh score >10).
Patients with chronic kidney disease (CKD) Stage 4 or 5 (eGFR <30mls/min).
History of coronary ischemia, peripheral vascular or cerebrovascular disease.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Abdullatif AL-Terki, MD	Amiri Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Al-Amiri Hospital		Kuwait City			Kuwait

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

Condition Browse Module

MeSH Terms

ID	Term
D056844	Renal Colic
D053039	Ureterolithiasis

Ancestor Terms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000082	Acetaminophen
C409945	parecoxib

Ancestor Terms

ID	Term
D000083	Acetanilides
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814

Browse Leaves

Not provided

Browse Branches

Not provided

Masking Info

Masking

Double

Masking Description

The emergency department (ED) nurse will do randomization by drawing one of the sealed closed envelopes that contain the analgesic to be administered.

Who Masked

ParticipantInvestigator