Clinical trial

The Investigation of the Efficacity and Safety of Oral Non Steroidal Anti Inflammatory (NSAI) Drugs Such as Piroxicam as a Second Line Treatment of Patients Consulting the Emergency Departement for Renal Colics.

Name

Oral NSAI in RC

Description

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.

Trial arms

Trial start

2014-01-01

Estimated PCD

2021-06-01

Trial end

2021-12-01

Status

Completed

Phase

Early phase I

Treatment

Piroxicam

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.

Arms:

Oral Piroxicam

Other names:

Piroxen

Placebo

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.

Arms:

Placebo

paracetamol

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.

Arms:

paracetamol

Size

1400

Primary endpoint

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

seven days

Eligibility criteria

Inclusion Criteria: * Over 18 years old * Consenting to participate in the study * Patients treated in the ED for RC * No contraindications of NSAI treatment Exclusion Criteria: * 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 1400, 'type': 'ACTUAL'}}

Updated at

2024-04-05

1 organization

2 products

1 drug

1 indication

Organization

University of Monastir

Product

Indication

Drug

Product