Parecoxib vs Paracetamol in the Treatment of Acute Renal Colic

NCT03704623 | Completed Phase 4

• 1 other identifier: Parecoxib vs Paracetamol
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Renal Colic; Ureteric Stone

Keywords

Acute renal colic; Ureteric stone; Selective COX2 inhibitor; Parecoxib; Paracetamol

Outcome Measures

Primary Outcomes (1)

• The need for rescue analgesia (Morphine)

  Patient who had persistent pain

  30 minutes

Secondary Outcomes (1)

• The incidence of adverse effects due to medication used

  24 hours

Study Arms (2)

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

Paracetamol DRUG

Paracetamol 1g IV

Also known as: Perfalgan

Paracetamol

Parecoxib DRUG

Parecoxib 40 mg IV

Also known as: Dynastat

Parecoxib

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical signs and symptoms consistent with acute renal colic

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead
• Amiri Hospital: collaborator

Study Sites (1)

Al-Amiri Hospital

Kuwait City, Kuwait

Location

MeSH Terms

Conditions

Renal Colic; Ureterolithiasis

Interventions

Acetaminophen; parecoxib

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Ureteral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Abdullatif AL-Terki, MD

  Amiri Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The emergency department (ED) nurse will do randomization by drawing one of the sealed closed envelopes that contain the analgesic to be administered.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Urology

Model Details: Eligible patients will be randomized to one of the two treatment groups.

Study Record Dates

• First Submitted: October 10, 2018
• First Posted: October 15, 2018
• Study Start: May 1, 2019
• Primary Completion: August 15, 2020
• Study Completion: August 15, 2020
• Last Updated: August 28, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

KU (1)