Renal ColicPhase 4NCT03865004
Combination Trial of Intravenous Paracetamol - Morphine for Treating Acute Renal Colic in Emergency Setting: An Optimum Treatment
A Phase 4 study testing Paracetamol+Morphine and Dexketoprofen plus Morphine in people with Renal Colic, run by Akdeniz University.
Trial summary
This randomized, placebo-controlled trial evaluated the analgesic efficacy and safety of intravenous morphine-paracetamol combination and morphine-dexketoprofen combination morphine for the optimum treatment of renal colic. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Renal Colic
- What is being tested?
- Paracetamol+Morphine and Dexketoprofen plus Morphine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 136 participants
- Where
- No sites listed yet
- Study dates
- 17 Oct 2015to 17 Oct 2018
- 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
None listed.
Who cannot join
- -
About this study
Official title: Paracetamol Plus Morphine in ED
This randomized, placebo-controlled trial evaluated the analgesic efficacy and safety of intravenous morphine-paracetamol combination and morphine-dexketoprofen combination morphine for the optimum treatment of renal colic. Combination of IV morphine and paracetamol is as effective and rapid as combination of IV Morphine and IV dexketoprophen for optimum treating of renal colic.
- Conditions
- Renal Colic
- Being tested
- Paracetamol+Morphine, Dexketoprofen plus Morphine, Placebo plus Morphine
- Medical subject headings
- Renal Colic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paracetamol+MorphineDrug
Also called Parol
1gr paracetamol plus 0.1 mg/kg morphine were performed simultanously
Dexketoprofen plus MorphineDrug
Also called Arveles
Intravenous 75 mg Dexketoprofen plus 0,1 mg/kg morphine were performed simultanously
Placebo plus MorphineDrug
Also called SF
100 cc NaCl plus 0.1 mg/kg morphine were performed simultanously
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Paracetamol+Morphine; Drug: Dexketoprofen plus Morphine; Drug: Placebo plus Morphine |
| Paracetamol | Active comparator | Not described Receives: Drug: Paracetamol+Morphine; Drug: Dexketoprofen plus Morphine; Drug: Placebo plus Morphine |
| Dexketoprofene | Active comparator | Not described Receives: Drug: Paracetamol+Morphine; Drug: Dexketoprofen plus Morphine; Drug: Placebo plus Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain reductions in VAS scores during the 60th and 90th minutes
Measured: 60 minutes
Secondary outcomes (1)
Need for rescue analgesic
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2019
- Study start17 Oct 2015
- Primary completion17 Oct 2016
- Study completion17 Oct 2018
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.
- More trials run by Akdeniz 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03865004
- Sponsor's protocol ID
- firatbektas
- Status last verified
- Mar 2019
- First submitted
- 4 Mar 2019
- Last updated
- 6 Mar 2019
- 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 6 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paracetamol Plus Morphine in ED
- ClinicalTrials.gov ID
- NCT03865004
- Acronym / sponsor ID
- firatbektas
- Conditions
- Renal Colic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 17 Oct 2015 (actual)
- Primary completion
- 17 Oct 2016 (actual)
- Study completion
- 17 Oct 2018 (actual)
- First posted
- 6 Mar 2019 (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 randomized, placebo-controlled trial evaluated the analgesic efficacy and safety of intravenous morphine-paracetamol combination and morphine-dexketoprofen combination morphine for the optimum treatment of renal colic. Combination of IV morphine and paracetamol is as effective and rapid as combination of IV Morphine and IV dexketoprophen for optimum treating of renal colic.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Paracetamol+Morphine, Drug: Dexketoprofen plus Morphine, Drug: Placebo plus Morphine |
| Paracetamol | Active comparator | Drug: Paracetamol+Morphine, Drug: Dexketoprofen plus Morphine, Drug: Placebo plus Morphine |
| Dexketoprofene | Active comparator | Drug: Paracetamol+Morphine, Drug: Dexketoprofen plus Morphine, Drug: Placebo plus Morphine |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Paracetamol+MorphineAlso: Parol1gr paracetamol plus 0.1 mg/kg morphine were performed simultanously | Drug | Dexketoprofene, Paracetamol, Placebo |
| Dexketoprofen plus MorphineAlso: ArvelesIntravenous 75 mg Dexketoprofen plus 0,1 mg/kg morphine were performed simultanously | Drug | Dexketoprofene, Paracetamol, Placebo |
| Placebo plus MorphineAlso: SF100 cc NaCl plus 0.1 mg/kg morphine were performed simultanously | Drug | Dexketoprofene, Paracetamol, Placebo |
Primary outcome
pain reductions in VAS scores during the 60th and 90th minutes
Time frame: 60 minutes
1 secondary outcome
Need for rescue analgesic
Time frame: 30 minutes
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 6 Mar 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Paracetamol+Morphine and Dexketoprofen plus Morphine in people with Renal Colic, run by Akdeniz University.
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 0 inclusion and 1 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 6 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
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 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?
pain reductions in VAS scores during the 60th and 90th minutes (time frame: 60 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 6 Mar 2019.