Renal ColicPhase 3ONSAIP-RCNCT02304783
Oral NSAI Versus Paracetamol or Placebo as a Second Line Treatment for Renal Colics
A Phase 3 study testing Piroxicam and paracetamol in people with Renal Colic, run by University of Monastir at 1 site in Tunisia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Colic
- What is being tested?
- Piroxicam and paracetamol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,400 participants
- Where
- 1 siteTunisia
- Study dates
- Jan 2014to Dec 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18 years old
- Consenting to participate in the study
- Patients treated in the ED for RC
- No contraindications of NSAI treatment
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Tunisia1 site
Emergency Department of University Hospital of Monastir
Monastir, 5050
About this study
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.
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.
Read the 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.
- Conditions
- Renal Colic
- Being tested
- Piroxicam, Placebo, paracetamol
- Keywords
- Renal colic, Piroxicam
- Medical subject headings
- Renal Colic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PiroxicamDrug
Also called Piroxen
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.
PlaceboDrug
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.
paracetamolDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Oral Piroxicam | Active comparator | Piroxicam : 20 mg per pill; one pill per day for five days associated with placebo (1pill) (taken separately) Receives: Drug: Piroxicam |
| Placebo | Placebo comparator | Placebo: two pills per day for five days (taken separately) Receives: Drug: Placebo |
| paracetamol | Active comparator | paracetamol: 2000mg per day for five days two pills taken separately) Receives: Drug: paracetamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: seven days
Secondary outcomes (1)
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
Measured: seven days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2014 (estimated)
- Study startJan 2014
- Primary completionJun 2021
- Study completionDec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal ColicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 1,400 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Monastir
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pr. Semir Nouira, University of Monastir
- Investigators
- Semir Nouira, MD, Principal investigator, University of Monastir
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02304783
- Sponsor's protocol ID
- Oral NSAI in RC
- Acronym
- ONSAIP-RC
- Status last verified
- Apr 2024
- First submitted
- 26 Nov 2014
- Last updated
- 5 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02304783
- Acronym / sponsor ID
- ONSAIP-RC / Oral NSAI in RC
- Conditions
- Renal Colic
- Keywords
- Renal colic, Piroxicam
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,400 participants (actual)
- Lead sponsor
- University of MonastirUniversity, hospital or other
- Study start
- Jan 2014 (actual)
- Primary completion
- Jun 2021 (actual)
- Study completion
- Dec 2021 (actual)
- First posted
- 2 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Oral Piroxicam | Active comparator | Drug: PiroxicamPiroxicam : 20 mg per pill; one pill per day for five days associated with placebo (1pill) (taken separately) |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo: two pills per day for five days (taken separately) |
| paracetamol | Active comparator | Drug: paracetamolparacetamol: 2000mg per day for five days two pills taken separately) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Over 18 years old
- Consenting to participate in the study
- Patients treated in the ED for RC
- No contraindications of NSAI treatment
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PiroxicamAlso: PiroxenPatients 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. | Drug | Oral Piroxicam |
| PlaceboPatients 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. | Drug | Placebo |
| paracetamolPatients 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. | Drug | paracetamol |
Primary outcome
Efficacity of oral NSAI (telephone call, asking for the recurrence of pain, the reconsultation rates and intervals and the need for other treatments)
Time frame: seven days
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)
1 secondary outcome
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)
Time frame: seven days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2024.
- official department siteLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Renal Colic
RecruitingPhase 3
Comparative Efficacy of IV Dexamethasone vs. Nebulized Terbutaline for Renal Colic Pain in the ED
Renal Colic
Not yet recruiting
Relief Efficacy of Lidocaine Versus Morphine for Acute Renal Colic in the Emergency Department
Renal Colic, Kidney Stones, Urolithiasis, Hypocitraturia
Recruiting
Ear Pressure Points Plus Pain Meds for Faster Kidney Stone Pain Relief
Renal Colic, Acupuncture, Ear
Active, not recruiting
Sterile Water Injection vs Morphine for Renal Colic
Renal Colic, Urolithiasis
Not yet recruitingPhase 4
Analgesic Efficacy of Transcutaneous Electrical Nerve Stimulation and Dexketoprofen in Renal Colic
Renal Colic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Semir Nouira, MD principal investigator
University of Monastir
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Piroxicam and paracetamol in people with Renal Colic, run by University of Monastir at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacity of oral NSAI (telephone call, asking for the recurrence of pain, the reconsultation rates and intervals and the need for other treatments) (time frame: seven days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2024; AzTrials last refreshed its copy on 6 Nov 2026.