Clincosm LogoSign in Get a demo

ONSAIP-RC: Oral NSAI Versus Paracetamol or Placebo as a Second Line Treatment for Renal Colics

Sponsor
University of Monastir (Other)
Overall Status
Recruiting
CT.gov ID
NCT02304783
Collaborator
(none)
500
Enrollment
1
Location
3
Arms
125
Anticipated Duration (Months)
4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Detailed Description

Renal colic (RC)are a frequent cause of consultation in the emergency departement (ED).

They count for approximatively 20% of patients presenting to the ED with severe acute onset abdominal pain.

The first line treatment of renal colics is based on NSAI drugs associated with antalgics and is further investigated in the NSAI vs Morphine study (NCT02156596).

But there is no clear recommendations regarding the outpatient treatment of renal colics.

Oral NSAI are still widely used as a second line medicine for this condition and variety of molecules were tried with no solid scientific arguments.

Piroxicam, a non-selective COX inhibitor drug appared to the Oxicam class of NSAI, is widely used to treat rheumatoid conditions and other inflammatory conditions and often prescribed in Tunisia as a second line treatment of RC.

In this study, we aimed to investigate the efficiency and safety of the use of oral NSAI drugs (Piroxicam) compared to paracetamol or placebo as a second line treatment of renal colics.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
500 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Treatment
Official Title:
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.
Actual Study Start Date :
Jan 1, 2014
Actual Primary Completion Date :
Jun 1, 2022
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Oral Piroxicam

Piroxicam : 20 mg per pill; one pill per day for five days

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

    		•
    Placebo Comparator: Placebo

    Placebo: one pill per day for five days

    Drug: 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.
    Active Comparator: paracetamol

    paracetamol: 1000mg per day for five days

    Drug: 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.

    Outcome Measures

    Primary Outcome Measures

    1. 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]

      The efficacity of the oral NSAI treatment was evaluated at the seventh day by a telephone call, asking for the recurrence of pain, the reconsultation rates and intervals and the need for other treatments (antalgics...)

    Secondary Outcome Measures

    1. Safety of NSAI (telephone call, asking for the occurence of NSAI side effects such as abdominal pain, vomiting, rush, bleeding and ect) [seven days]

      The efficacity of the oral NSAI treatment was evaluated at the seventh day by a telephone call, asking for the occurence of NSAI side effects such as abdominal pain, vomiting, rush, bleeding and ect

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Over 16 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Emergency Department of University Hospital of Monastir Monastir Tunisia 5050

    Sponsors and Collaborators

    • University of Monastir

    Investigators

    • Principal Investigator: Semir Nouira, MD, University of Monastir

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Pr. Semir Nouira, Professor, University of Monastir
    ClinicalTrials.gov Identifier:
    NCT02304783
    Other Study ID Numbers:
    • Oral NSAI in RC
    First Posted:
    Dec 2, 2014
    Last Update Posted:
    Aug 17, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Pr. Semir Nouira, Professor, University of Monastir
    Renal colic, Piroxicam
    Additional relevant MeSH terms:
    Colic
    Renal Colic
    Acetaminophen
    Piroxicam

    Study Results

    No Results Posted as of Aug 17, 2022