Oral NSAI Versus Acetaminophen or Placebo as a Discharge Treatment of Non Complicated Renal Colics (NAP-RC)
Primary Purpose
Renal Colic
Status
Recruiting
Phase
Phase 2
Locations
Tunisia
Study Type
Interventional
Intervention
Piroxicam
Acetaminophen
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Renal Colic focused on measuring Renal Colic, NSAI, Acetaminophen
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: Contraindication of NSAI treatment Patients non reachable by telephone call Patients that did not receive or use the treatment
Sites / Locations
- Fattouma Bourguiba University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
NSAI
Acetaminophen
Placebo
Arm Description
Piroxicam: 20 mg per pill; one pill per day for five days
Paracetamol: 1000 mg per day for five days
Placebo: one pill per day for five days
Outcomes
Primary Outcome Measures
Efficacity of oral NSAI
The efficacity of the oral NSAI treatment was evaluated at the seventh day by a telephone call, asking for the reccurence of pain, the reconsultation rates and intervals and the need for other treatments (antalgics...)
Secondary Outcome Measures
Safety of NSAI
Safety was evaluated by a telephone call asking for the occurence of NSAI side effects such as abdominal pain , vomiting , rush, bleeding or others
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05722782
Brief Title
Oral NSAI Versus Acetaminophen or Placebo as a Discharge Treatment of Non Complicated Renal Colics
Acronym
NAP-RC
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 Department for Renal Colics
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2023 (Anticipated)
Primary Completion Date
June 2027 (Anticipated)
Study Completion Date
December 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Monastir
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Treatment with NSAI in renal colics has not been well investigated and there is no clear recommendations regarding this subject.
The aim of this study is to determine if an oral NSAI treatment is beneficial in patients discharged for the emergency department after the first line treatment of a renal colic investigating the reccurence of pain, the reconsultation rates and the admissions.
Detailed Description
Renal colic (RC) are a frequent cause of consultation in the emergency departement (ED). It counts 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 non solid scientific arguments.
Piroxicam, a non-selective COX inhibitor drug appared to the oxicam class of NSAI, is widely used to treat rhumatoid and inflammatory disesases, and often prescribed in Tunisia as a second line treatment of RC.
In this study, the investigators aimed to investigate the efficiency and safety of the use of oral NSAI drugs (piroxicam) compared to Acetaminophen or placebo as a second line treatment of renal colics
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Colic
Keywords
Renal Colic, NSAI, Acetaminophen
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NSAI
Arm Type
Active Comparator
Arm Description
Piroxicam: 20 mg per pill; one pill per day for five days
Arm Title
Acetaminophen
Arm Type
Active Comparator
Arm Description
Paracetamol: 1000 mg per day for five days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo: one pill per day for five days
Intervention Type
Drug
Intervention Name(s)
Piroxicam
Other Intervention Name(s)
Piroxen
Intervention Description
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 efficacy and the side effects of the treatment
Intervention Type
Drug
Intervention Name(s)
Acetaminophen
Intervention Description
Patients allocated to this arm received , as a second line treatment of renal colics , a five days treatment with 1000 mg Acetaminophen per day and were contacted at the seventh day by telephone call to investigate the efficacy and the side effects of the treatment
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Patients allocated to this arm received , as a second line treatment of renal colics , a five days treatment with placebo per day and were contacted at the seventh day by telephone call to investigate the efficacy and the side effects of the treatment
Primary Outcome Measure Information:
Title
Efficacity of oral NSAI
Description
The efficacity of the oral NSAI treatment was evaluated at the seventh day by a telephone call, asking for the reccurence of pain, the reconsultation rates and intervals and the need for other treatments (antalgics...)
Time Frame
07 days
Secondary Outcome Measure Information:
Title
Safety of NSAI
Description
Safety was evaluated by a telephone call asking for the occurence of NSAI side effects such as abdominal pain , vomiting , rush, bleeding or others
Time Frame
07 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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:
Contraindication of NSAI treatment
Patients non reachable by telephone call
Patients that did not receive or use the treatment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nouira semir, MD
Phone
73106000
Ext
+216
Email
semir.nouira@rns.tn
Facility Information:
Facility Name
Fattouma Bourguiba University Hospital
City
Monastir
ZIP/Postal Code
5000
Country
Tunisia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
samir nouira, MD
12. IPD Sharing Statement
Learn more about this trial
Oral NSAI Versus Acetaminophen or Placebo as a Discharge Treatment of Non Complicated Renal Colics
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