A Phase 3 interventional study of Piroxicam and Placebo in Renal Colic, sponsored by University of Monastir. Completed at 1 site in Tunisia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-05.
Sponsored by University of Monastir · Phase 3, 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 one of 2 that started in 2014, is one of 3 in phase 3, and was the 3rd registered.
79 studies on the registry are indexed under Renal Colic; 10 are open to participants now.
This study's enrollment of 1,400 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. 2 started in 2014.
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:
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.
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.
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 associated with placebo (1pill) (taken separately)
Drug: Piroxicam
Placebo: two pills per day for five days (taken separately)
Drug: Placebo
paracetamol: 2000mg per day for five days two pills taken separately)
Drug: paracetamol
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
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.
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.
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)
Time frame: seven days
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)
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
Time frame: seven days
Plan to share: No
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drugs tested here: Piroxicam · Acetaminophen