Renal ColicPhase 2RCNCT06345716
Paracetamol-Tramadol and Paracetamol-caffeine Versus Placebo in the Emergency Discharge Treatment of Renal Colic
A Phase 2 study testing paracétamol tramadol and Paracétamol cafeine in people with Renal Colic, run by University of Monastir at 1 site in Tunisia.
Trial summary
This is a prospective, randomized, single-blind study. Patients included in the study after successful treatment of the acute attack were randomized upon discharge from the Emergency Department into three groups: oral paracetamol-tramadol group, oral paracetamol-caffeine group and oral placebo group. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Renal Colic
- What is being tested?
- paracétamol tramadol and Paracétamol cafeine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,500 participants
- Where
- 1 siteTunisia
- Study dates
- 10 Apr 2024to 30 Nov 2025
- Phase
- Phase 2
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -Age > 18 years old.
- Consent to participate in the study.
- Pain in the flank/lumbar fossa of sudden onset with urine strips and/or imaging corresponding to the diagnosis of renal colic.
- Pain score at discharge < 30 (visual analog scale - VAS or verbal numerical scale - VAS from 0 to 100).
Who cannot join
- -Inability to appreciate pain according to the VAS.
- Pregnant or breastfeeding woman.
- Renal insufficiency with creatinine clearance < 60 ml/min.
Trial locations and contacts
1 site in 1 country.
Semir Nouira, Pr contact
Tunisia1 site, 1 recruiting
- Recruiting
Semir Nouira
Monastir
semir nouirq, professor, 0021673106046, semir.nouira.urg@gmail.com
About this study
This is a prospective, randomized, single-blind study. Patients included in the study after successful treatment of the acute attack were randomized upon discharge from the Emergency Department into three groups: oral paracetamol-tramadol group, oral paracetamol-caffeine group and oral placebo group.
Read the detailed description
This is a prospective, randomized, single-blind study. Patients included in the study after successful treatment of the acute attack were randomized upon discharge from the Emergency Department into three groups: oral paracetamol-tramadol group, oral paracetamol-caffeine group and oral placebo group.
Different parameters are collected on a standard form prepared for all cases of renal colic included in our study. This sheet essentially contains:
Temperature, systolic and diastolic blood pressure, heart rate, pain intensity assessed by VAS, abdominal tenderness as well as the existence of Giardano signs.
Additional examinations were not systematically carried out for all patients: AUSP, ECBU, renal ultrasound, creatinemia and blood sugar. Their realization depended on the clinical context.
The use of imaging was done following the indications specified in the text of the consensus of the French Society of Emergency Medicine (updated in 2008)
- Conditions
- Renal Colic
- Being tested
- paracétamol tramadol, Paracétamol cafeine, Placebo
- Keywords
- renal colic, paracetamol-tramadol, paracetamol-cafeine, placebo
- Medical subject headings
- Renal Colic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paracétamol tramadolDrug
Also called B
Each patient received 1 tablet * 2/day synalvic (325 mg of paracetamol + 37.5 mg of tramadol) for 7 days
Paracétamol cafeineDrug
Also called A
Each patient received 1 tab * 3/d stopalgic extra (65mgcaffeine+500mg paracetamol) for 7 days
PlaceboDrug
Also called C
Each patient received 1 tab * 3 / d of placebo (flour) every day for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Paracétamol-tramadol | Experimental | Each patient received 1 tablet * 2/day synalvic (325 mg of paracetamol + 37.5 mg of tramadol) for 7 days. Receives: Drug: paracétamol tramadol |
| Paracetamol-caffeine | Experimental | Each patient received 1 tab * 3/d stopalgic extra (65mgcaffeine+500mg paracetamol) for 7 days Receives: Drug: Paracétamol cafeine |
| Placebo | Experimental | Each patient received 1 tab * 3 / d of placebo (flour) every day for 7 days.
*For the three groups, the tablets were packaged hermetically in identical envelopes taken at random to respect double blinding. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of RC and ED readmission
included recurrence of RC and ED readmission within 7-day follow-up
Measured: 7 day after inclusion
Secondary outcomes (2)
mean time interval
mean time to recurrence of pain
Measured: 7 day after inclusion
side effects
occurence of side effects
Measured: 7 days 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start10 Apr 2024
- Primary completion15 Mar 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,500 participants (estimated)
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
- Khaoula Bel Haj Ali, Study director, CHU Fattouma Bourguiba Monastir, service des urgences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06345716
- Sponsor's protocol ID
- renal colic 2024
- Acronym
- RC
- Status last verified
- Sep 2024
- First submitted
- 8 Mar 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paracetamol-Tramadol and Paracetamol-caffeine Versus Placebo in the Emergency Discharge Treatment of Renal Colic
- ClinicalTrials.gov ID
- NCT06345716
- Acronym / sponsor ID
- RC / renal colic 2024
- Conditions
- Renal Colic
- Keywords
- renal colic, paracetamol-tramadol, paracetamol-cafeine, placebo
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- University of MonastirUniversity, hospital or other
- Study start
- 10 Apr 2024 (actual)
- Primary completion
- 15 Mar 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 3 Apr 2024 (actual)
- 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.
This is a prospective, randomized, single-blind study. Patients included in the study after successful treatment of the acute attack were randomized upon discharge from the Emergency Department into three groups: oral paracetamol-tramadol group, oral paracetamol-caffeine group and oral placebo group.
Detailed description
This is a prospective, randomized, single-blind study. Patients included in the study after successful treatment of the acute attack were randomized upon discharge from the Emergency Department into three groups: oral paracetamol-tramadol group, oral paracetamol-caffeine group and oral placebo group.
Different parameters are collected on a standard form prepared for all cases of renal colic included in our study. This sheet essentially contains:
Temperature, systolic and diastolic blood pressure, heart rate, pain intensity assessed by VAS, abdominal tenderness as well as the existence of Giardano signs.
Additional examinations were not systematically carried out for all patients: AUSP, ECBU, renal ultrasound, creatinemia and blood sugar. Their realization depended on the clinical context.
The use of imaging was done following the indications specified in the text of the consensus of the French Society of Emergency Medicine (updated in 2008)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Paracétamol-tramadol | Experimental | Drug: paracétamol tramadolEach patient received 1 tablet * 2/day synalvic (325 mg of paracetamol + 37.5 mg of tramadol) for 7 days. |
| Paracetamol-caffeine | Experimental | Drug: Paracétamol cafeineEach patient received 1 tab * 3/d stopalgic extra (65mgcaffeine+500mg paracetamol) for 7 days |
| Placebo | Experimental | Drug: PlaceboEach patient received 1 tab * 3 / d of placebo (flour) every day for 7 days. *For the three groups, the tablets were packaged hermetically in identical envelopes taken at random to respect double blinding. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- -Age > 18 years old.
- Consent to participate in the study.
- Pain in the flank/lumbar fossa of sudden onset with urine strips and/or imaging corresponding to the diagnosis of renal colic.
- Pain score at discharge < 30 (visual analog scale - VAS or verbal numerical scale - VAS from 0 to 100).
Key exclusion criteria (3 listed)
- -Inability to appreciate pain according to the VAS.
- Pregnant or breastfeeding woman.
- Renal insufficiency with creatinine clearance < 60 ml/min.
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 |
|---|---|---|
| paracétamol tramadolAlso: BEach patient received 1 tablet * 2/day synalvic (325 mg of paracetamol + 37.5 mg of tramadol) for 7 days | Drug | Paracétamol-tramadol |
| Paracétamol cafeineAlso: AEach patient received 1 tab * 3/d stopalgic extra (65mgcaffeine+500mg paracetamol) for 7 days | Drug | Paracetamol-caffeine |
| PlaceboAlso: CEach patient received 1 tab * 3 / d of placebo (flour) every day for 7 days | Drug | Placebo |
Primary outcome
Recurrence of RC and ED readmission
Time frame: 7 day after inclusion
included recurrence of RC and ED readmission within 7-day follow-up
2 secondary outcomes
mean time interval
Time frame: 7 day after inclusion
side effects
Time frame: 7 days 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- 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, Pr contact
Khaoula Bel Haj Ali study director
CHU Fattouma Bourguiba Monastir, service des urgences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing paracétamol tramadol and Paracétamol cafeine 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 3 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: status not confirmed, as of the sponsor's last update on 19 Sep 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Khaoula Bel Haj Ali (99792724, belhajalikhaoula@yahoo.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of RC and ED readmission (time frame: 7 day after inclusion). 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 19 Sep 2024.