A Phase 2 interventional study of Piroxicam and Acetaminophen in Renal Colic, sponsored by University of Monastir. Recruiting at 1 site in Tunisia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-14.
Sponsored by University of Monastir · Phase 2, Interventional, and Treatment
Among 10 studies in Renal Colic by University of Monastir — 3 open to participants now, 3 under way, 1 of them phase 3. Renal Colic · University of Monastir.
Among the 10 studies in Renal Colic by University of Monastir, this one is the only one that started in 2023, is one of 4 in phase 2, and was the 7th registered.
79 studies on the registry are indexed under Renal Colic; 10 are open to participants now.
This study's planned enrollment of 500 is above the median of 118 across 60 interventional studies indexed under Renal Colic.
Browse Renal Colic studies →3 of the 10 studies in Renal Colic by University of Monastir are open now, in 1 country. Each count lists the studies.
Of the 5 Renal Colic studies recruiting now, 2 (40%) set no upper age limit and 2 (40%) stop at 75 or younger; 0 take children under 18; 0 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →10 studies; the count open now beside each. This study's row is marked.
First in 2012; this study’s year is marked. 1 started in 2023.
Median enrollment 500 across the 9 interventional studies, 878 across the 1 observational. Of the 7 that completed or were terminated, 0 (0%) have results posted.
University of Monastir is the lead sponsor of 114 studies on the registry; 29 are open to participants now.
1 of the studies in Renal Colic by University of Monastir that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05722782University of MonastirOral NSAI Versus Acetaminophen or Placebo as a Discharge Treatment of Non Complicated Renal Colics | 2027-06 |
Among the 10 studies in Renal Colic by University of Monastir, from their registry updates:
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.
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Piroxicam: 20 mg per pill; one pill per day for five days
Drug: Piroxicam
Paracetamol: 1000 mg per day for five days
Drug: Acetaminophen
Placebo: one pill per day for five days
Drug: Placebo
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
Also known as: Piroxen
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
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
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...)
Time frame: 07 days
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
Time frame: 07 days
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Studies of the drugs tested here: Piroxicam · Acetaminophen