Ureteral Calculi, Hyperalgic, Not ComplicatedPhase 4NCT00639574
Nefopam and Morphine Consumption in the Treatment of Ureteral Calculi
A Phase 4 study testing Néfopam in people with Ureteral Calculi, Hyperalgic, Not Complicated, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
The administration of néfopam after initial treatment by kétoproféne, could obtain, in patients remaining pain and classically need morphine, analgesia at least the same as morphine alone. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Ureteral Calculi, Hyperalgic, Not Complicated
- What is being tested?
- Néfopam
- How many people
- 52 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2008to Sep 2009
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18 to 50 years old.
- Admitted to the emergency room for typical ureteral calculi with severe pain (VAS > or = 60), and microscopic hematuria in the strip without signs of urinary complications.
- Preliminary Agreement patient.
Who cannot join
- Patient disagree.
- Pregnant women (sought by the questioning).
- Fever > 38 ° C.
- Leucocyturie or nitriturie (dipstick).
- Contraindication to ketoprofen.
- Contraindication to néfopam.
Show all 10Show fewer
- Contraindication to morphine.
- Contraindication linked to drug interactions as mentioned in the Summary of Product Characteristics of the Authorization for placing on the market of Acupan ®.
- Treatment opioid analgesics, nonsteroidal anti-inflammatory or inflammatory or paracetamol in the previous 12 hours.
- Secondary exclusion to a urinary tract infection or systemic.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interest of Néfopam in the Treatment of Pain During the Intense Ureteral Calculi Uncomplicated in Adults in Emergencies Unit.
The administration of néfopam after initial treatment by kétoproféne, could obtain, in patients remaining pain and classically need morphine, analgesia at least the same as morphine alone. The use of néfopam second line after ketoprofen could reducing (or even eliminating) the need for morphine (and its side effects), allowing a reduction in the length of stay of patients in the emergency unit.
The main objective is to show that the addition of a néfopam initial treatment with the kétoproféne, reduces, in patients with ureteral calculi, the percentage of patients requiring the use of a treatment by morphine.
The secondary objective is to reduce the side effects caused by the morphine, shorten the time to install the appropriate level of analgesia while reducing the risk of failure of the titration morphine, reduce the time spent on titration of morphine and reduce the length of stay patient intake in emergency unit.
Read the detailed description
The study is prospective, parallel, double-blind, randomized, placebo-controlled analysis with intent to treat. There are 2 groups:
- A group N: néfopam
- A group P: placebo And all the patient receive, before randomization, 100 mg of ketoprofen (Profenid ®) on 20 minutes.
The number of subjects is 52.
- Being tested
- Néfopam
- Keywords
- Pain, morphine, nefopam, co analgesia, ureteral calculi, emergency
- Medical subject headings
- Ureteral Calculi, Pain, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NéfopamDrug
There are two groups :
- a group N : néfopam
- a group P : placebo All the patients receive, before randomization, 100 mg of ketoprofen (Profenid) on 20 minutes.
What is being measured
The primary outcome is the main question the study is designed to answer.
Need to use morphine as an analgesic scheme (binary yes/no)
Measured: As analgesic scheme
Secondary outcomes (3)
Quantity of morphine consumed after titration (mg and number of bolus)
Measured: After titration and after administration of placebo or néfopam
Pain (measured by the EVA) after administration of placebo or néfopam
Measured: After titration and after administration of placebo or néfopam
Simplified verbal Scale of Satisfaction
Measured: After titration and after administration of placebo or néfopam
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionNov 2008
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ureteral Calculi, Hyperalgic, Not ComplicatedStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Investigators
- Moustafa Fares, Dr, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00639574
- Sponsor's protocol ID
- CHU-0030
- Status last verified
- Mar 2010
- First submitted
- 14 Mar 2008
- Last updated
- 29 Mar 2010
- Results posted
- No
Publications
Moustafa F, Liotier J, Mathevon T, Pic D, Perrier C, Schmidt J. Usefulness of nefopam in treating pain of severe uncomplicated renal colics in adults admitted to emergency units: a randomised double-blind controlled trial. The 'INCoNU' study. Emerg Med J. 2013 Feb;30(2):143-8. doi: 10.1136/emermed-2011-200753. Epub 2012 Mar 16.
PubMed 22427403
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Néfopam in the Treatment of Pain During the Intense Ureteral Calculi Uncomplicated in Adults in Emergencies Unit.
- ClinicalTrials.gov ID
- NCT00639574
- Acronym / sponsor ID
- CHU-0030
- Keywords
- Pain, morphine, nefopam, co analgesia, ureteral calculi, emergency
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 20 Mar 2008 (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.
The administration of néfopam after initial treatment by kétoproféne, could obtain, in patients remaining pain and classically need morphine, analgesia at least the same as morphine alone. The use of néfopam second line after ketoprofen could reducing (or even eliminating) the need for morphine (and its side effects), allowing a reduction in the length of stay of patients in the emergency unit.
The main objective is to show that the addition of a néfopam initial treatment with the kétoproféne, reduces, in patients with ureteral calculi, the percentage of patients requiring the use of a treatment by morphine.
The secondary objective is to reduce the side effects caused by the morphine, shorten the time to install the appropriate level of analgesia while reducing the risk of failure of the titration morphine, reduce the time spent on titration of morphine and reduce the length of stay patient intake in emergency unit.
Detailed description
The study is prospective, parallel, double-blind, randomized, placebo-controlled analysis with intent to treat. There are 2 groups:
- A group N: néfopam
- A group P: placebo And all the patient receive, before randomization, 100 mg of ketoprofen (Profenid ®) on 20 minutes.
The number of subjects is 52.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age between 18 to 50 years old.
- Admitted to the emergency room for typical ureteral calculi with severe pain (VAS > or = 60), and microscopic hematuria in the strip without signs of urinary complications.
- Preliminary Agreement patient.
Key exclusion criteria (10 listed)
- Patient disagree.
- Pregnant women (sought by the questioning).
- Fever > 38 ° C.
- Leucocyturie or nitriturie (dipstick).
- Contraindication to ketoprofen.
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 |
|---|---|---|
| NéfopamThere are two groups : * a group N : néfopam * a group P : placebo All the patients receive, before randomization, 100 mg of ketoprofen (Profenid) on 20 minutes. | Drug | – |
Primary outcome
Need to use morphine as an analgesic scheme (binary yes/no)
Time frame: As analgesic scheme
3 secondary outcomes
Quantity of morphine consumed after titration (mg and number of bolus)
Time frame: After titration and after administration of placebo or néfopam
Pain (measured by the EVA) after administration of placebo or néfopam
Time frame: After titration and after administration of placebo or néfopam
Simplified verbal Scale of Satisfaction
Time frame: After titration and after administration of placebo or néfopam
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 29 Mar 2010.
- Derived from this study: PubMed 22427403Moustafa F, Liotier J, Mathevon T, Pic D, Perrier C, Schmidt J. Usefulness of nefopam in treating pain of severe uncomplicated renal colics in adults admitted to emergency units: a randomised double-blind controlled trial. The 'INCoNU' study. Emerg Med J. 2013 Feb;30(2):143-8. doi: 10.1136/emermed-2011-200753. Epub 2012 Mar 16.
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.
Moustafa Fares, Dr principal investigator
University Hospital, Clermont-Ferrand
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 Néfopam in people with Ureteral Calculi, Hyperalgic, Not Complicated, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 3 inclusion and 10 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 29 Mar 2010. 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 France. 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?
Need to use morphine as an analgesic scheme (binary yes/no) (time frame: As analgesic scheme). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00639574, which also lists 1 linked publication.
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 29 Mar 2010.