Oral NSAI Versus Paracetamol or Placebo as a Second Line Treatment for Renal Colics

NCT02304783 | Completed Phase 3

• 1 other identifier: Oral NSAI in RC
• Study Type: interventional
• Target: 1,400
• Locations: 1 country
• Sites: 1

Brief Summary

Outpatients treatment with NSAI in renal colics has not been well investigated and there is no clear recommendations regarding this matter. The aim of this study is to determine if an oral NSAI treatment is beneficial in patients discharged for the emergency departement after the first line treatment of a renal colic investigating the recurrence of pain, the reconsultation rates and the admissions.

Conditions

Renal Colic

Keywords

Renal colic, Piroxicam

Outcome Measures

Primary Outcomes (1)

• Efficacity of oral NSAI (telephone call, asking for the recurrence of pain, the reconsultation rates and intervals and the need for other treatments)

  The efficacity of the oral NSAI treatment was evaluated at the seventh day by a telephone call, asking for the recurrence of painand the readmission rates)

  seven days

Secondary Outcomes (1)

• Safety of NSAI (telephone call, asking for mean time to recurrence and the occurence of NSAI side effects such as abdominal pain, vomiting, rush, bleeding and ect)

  seven days

Study Arms (3)

Oral Piroxicam

ACTIVE COMPARATOR

Piroxicam : 20 mg per pill; one pill per day for five days associated with placebo (1pill) (taken separately)

Drug: Piroxicam

Placebo

PLACEBO COMPARATOR

Placebo: two pills per day for five days (taken separately)

Drug: Placebo

paracetamol

ACTIVE COMPARATOR

paracetamol: 2000mg per day for five days two pills taken separately)

Drug: paracetamol

Interventions

Piroxicam DRUG

Patients allocated to this arm received, as a second line treatment of renal colics, a five days treatment with 20 mg piroxicam associated with placebo per day and were contacted at the seventh day by telephone call to investigate the efficacity and the side effects of the treatment.

Also known as: Piroxen

Oral Piroxicam

Placebo DRUG

Patients allocated to this arm received a five days treatment with Placebo and were contacted at the seventh day by telephone call to investigate the efficacity and the side effects of the treatment.

Placebo

paracetamol DRUG

Patients allocated to this arm received a five days treatment with Paracetamol and were contacted at the seventh day by telephone call to investigate the efficacity and the side effects of the treatment.

paracetamol

Eligibility Criteria

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

You may qualify if:

• Over 18 years old
• Consenting to participate in the study
• Patients treated in the ED for RC
• No contraindications of NSAI treatment

You may not qualify if:

• Patients excluded from the first phase of the study
• Contraindication of NSAI treatment
• Patients non reachable by telephone call
• Patients that did not receive or use the treatment

Sponsors & Collaborators

• University of Monastir: lead

Study Sites (1)

Emergency Department of University Hospital of Monastir

Monastir, 5050, Tunisia

Location

Related Links

• official department site

MeSH Terms

Conditions

Renal Colic

Interventions

Piroxicam; Acetaminophen

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiazines; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Acetanilides; Anilides; Amides; Aniline Compounds; Amines

Study Officials

• Semir Nouira, MD

  University of Monastir

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 26, 2014
• First Posted: December 2, 2014
• Study Start: January 1, 2014
• Primary Completion: June 1, 2021
• Study Completion: December 1, 2021
• Last Updated: April 5, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)