Acute Renal ColicPhase 4NCT03704623
Parecoxib vs Paracetamol in the Treatment of Acute Renal Colic
A Phase 4 study testing Paracetamol and Parecoxib in people with Acute Renal Colic and Ureteric Stone, run by Mansoura University at 1 site in Kuwait.
Trial summary
This study will be conducted to compare the efficacy and safety of Parecoxib versus Paracetamol for treatment of acute renal colic due to ureteric stones. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Acute Renal Colic, Ureteric Stone
- What is being tested?
- Paracetamol and Parecoxib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteKuwait
- Study dates
- 1 May 2019to 15 Aug 2020
- Phase
- Phase 4
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical signs and symptoms consistent with acute renal colic
Who cannot join
- Hypersensitivity to either Paracetamol or Parecoxib.
- History of peptic ulcer.
- Pregnant or breastfeeding females.
- Patients with hepatic impairment (Child-Pugh score >10).
- Patients with chronic kidney disease (CKD) Stage 4 or 5 (eGFR <30mls/min).
- History of coronary ischemia, peripheral vascular or cerebrovascular disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Parecoxib vs Paracetamol in the Treatment of Acute Renal Colic Due to Ureteric Calculi: Randomized Controlled Trial
This study will be conducted to compare the efficacy and safety of Parecoxib versus Paracetamol for treatment of acute renal colic due to ureteric stones.
Read the detailed description
Eligible patients will be randomized to one of the two treatment groups. Group 1 patients will receive IV 1 g of Paracetamol while group 2 patients will receive 40 mg of Parecoxib IV.
The Visual Analogue Scale (VAS) will be calculated on presentation and at 30 minutes after analgesia administration. Patients who do not respond to an initial dose of the analgesia will receive rescue analgesia in the form of Morphine, 01.mg/kg, IV.
- Conditions
- Acute Renal Colic, Ureteric Stone
- Being tested
- Paracetamol, Parecoxib
- Keywords
- Acute renal colic, Ureteric stone, Selective COX2 inhibitor, Parecoxib, Paracetamol
- Medical subject headings
- Renal Colic, Ureterolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParacetamolDrug
Also called Perfalgan
Paracetamol 1g IV
ParecoxibDrug
Also called Dynastat
Parecoxib 40 mg IV
| Study group | Role | What they receive |
|---|---|---|
| Paracetamol | Active comparator | Patients will receive IV 1 g of Paracetamol Receives: Drug: Paracetamol |
| Parecoxib | Active comparator | Patients will receive 40 mg of Parecoxib IV Receives: Drug: Parecoxib |
What is being measured
The primary outcome is the main question the study is designed to answer.
The need for rescue analgesia (Morphine)
Patient who had persistent pain
Measured: 30 minutes
Secondary outcomes (1)
The incidence of adverse effects due to medication used
Assessment of adverse effects of the drug used
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2018
- Study start1 May 2019
- Primary completion15 Aug 2020
- Study completion15 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Renal ColicStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible patients will be randomized to one of the two treatment groups.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Collaborators
- Amiri Hospital
- Responsible party
- Principal investigator, Ahmed R. EL-Nahas, Mansoura University
- Investigators
- Abdullatif AL-Terki, MD, Study chair, Amiri Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03704623
- Sponsor's protocol ID
- Parecoxib vs Paracetamol
- Status last verified
- Aug 2020
- First submitted
- 10 Oct 2018
- Last updated
- 28 Aug 2020
- 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 28 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parecoxib vs Paracetamol in the Treatment of Acute Renal Colic Due to Ureteric Calculi: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03704623
- Acronym / sponsor ID
- Parecoxib vs Paracetamol
- Conditions
- Acute Renal Colic, Ureteric Stone
- Keywords
- Acute renal colic, Ureteric stone, Selective COX2 inhibitor, Parecoxib, Paracetamol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Collaborators
- Amiri Hospital
- Study start
- 1 May 2019 (actual)
- Primary completion
- 15 Aug 2020 (actual)
- Study completion
- 15 Aug 2020 (actual)
- First posted
- 15 Oct 2018 (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 study will be conducted to compare the efficacy and safety of Parecoxib versus Paracetamol for treatment of acute renal colic due to ureteric stones.
Detailed description
Eligible patients will be randomized to one of the two treatment groups. Group 1 patients will receive IV 1 g of Paracetamol while group 2 patients will receive 40 mg of Parecoxib IV.
The Visual Analogue Scale (VAS) will be calculated on presentation and at 30 minutes after analgesia administration. Patients who do not respond to an initial dose of the analgesia will receive rescue analgesia in the form of Morphine, 01.mg/kg, IV.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Eligible patients will be randomized to one of the two treatment groups.
| Arm | Type | Receives |
|---|---|---|
| Paracetamol | Active comparator | Drug: ParacetamolPatients will receive IV 1 g of Paracetamol |
| Parecoxib | Active comparator | Drug: ParecoxibPatients will receive 40 mg of Parecoxib IV |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical signs and symptoms consistent with acute renal colic
Key exclusion criteria (6 listed)
- Hypersensitivity to either Paracetamol or Parecoxib.
- History of peptic ulcer.
- Pregnant or breastfeeding females.
- Patients with hepatic impairment (Child-Pugh score >10).
- Patients with chronic kidney disease (CKD) Stage 4 or 5 (eGFR <30mls/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 |
|---|---|---|
| ParacetamolAlso: PerfalganParacetamol 1g IV | Drug | Paracetamol |
| ParecoxibAlso: DynastatParecoxib 40 mg IV | Drug | Parecoxib |
Primary outcome
The need for rescue analgesia (Morphine)
Time frame: 30 minutes
Patient who had persistent pain
1 secondary outcome
The incidence of adverse effects due to medication used
Time frame: 24 hours
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 28 Aug 2020.
- Individual participant dataSharing planned: No
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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.
Abdullatif AL-Terki, MD study chair
Amiri Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Paracetamol and Parecoxib in people with Acute Renal Colic and Ureteric Stone, run by Mansoura University at 1 site in Kuwait.
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 1 inclusion and 6 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 28 Aug 2020. 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 Kuwait. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
The need for rescue analgesia (Morphine) (time frame: 30 minutes). 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 28 Aug 2020.