E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
acute musculoskeletal syndromes |
acute musculoskeletale syndromen |
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E.1.1.1 | Medical condition in easily understood language |
Strains and sprains |
Distorsies en kneuzingen |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10002182 |
E.1.2 | Term | Analgesia |
E.1.2 | System Organ Class | 100000004865 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10033762 |
E.1.2 | Term | Paracetamol |
E.1.2 | System Organ Class | 100000004848 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.1 |
E.1.2 | Level | HLGT |
E.1.2 | Classification code | 10005942 |
E.1.2 | Term | Bone and joint injuries |
E.1.2 | System Organ Class | 10022117 - Injury, poisoning and procedural complications |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.1 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10028288 |
E.1.2 | Term | Muscle, tendon and ligament injuries |
E.1.2 | System Organ Class | 10022117 - Injury, poisoning and procedural complications |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective of the study is to compare the effect in treatment of pain with three different strategies of pain management in patients presenting to an Emergency Department and to a general practice with acute musculoskeletal syndromes (defined as musculoskeletal complaints after sustaining an injury with exclusion of a fracture). The strategies of pain management which will be compared are paracetamol, diclofenac and the combination of paracetamol and diclofenac.
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Primaire doel van de studie is het vergelijken van het effect in pijnbestrijding van drie verschillende behandelingsstrategieen bij patienten die zich presenteren op de Spoedeisende Hulp en in een huisartsenpraktijk met acute musculoskeletale syndromen (gedefineerd als musculoskeletale klachten na een trauma, waarbij een fractuur wordt geexcludeerd). De strategieen die vergeleken gaan worden zijn: paracetamol, diclofenac en de combinatie van beiden. |
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E.2.2 | Secondary objectives of the trial |
Secondary objectives of the study are safety of the three different strategies of pain management, patient satisfaction with the treatment and a cost-effectiveness analysis.
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Secundaire doelen zijn veiligheid van de drie verschillende strategieen van pijnbestrijding, patient tevredenheid met de behandeling en een kosten-baten analyse. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- adult (18 years and older) patients
- presenting to the emergency department of the Academic Medical Centre (AMC) or to a general practice in Amsterdam South-East (Gezondheidscentrum Gein)
- with traumatic musculoskeletal complaints: isolated, non-penetrating injury of a limb, without a fracture
- within 48 hours
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- volwassen patienten (18 jaar en ouder)
- die zich presenteren op de afdeling Spoedeisende Hulp van het AMC of bij Gezondheidscentrum Gein (een huisartsenpraktijk in Amsterdam Zuidoost)
- met traumatische musculoskeletale klachten: niet-penetrerend extremiteitsletsel, d.w.z. een pijnlijke acute kneuzing of distorsie van een extremiteit
- minder dan 48 uur voor presentatie |
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E.4 | Principal exclusion criteria |
- previous treatment with analgesia for the same injury
- self inflicted injury (“auto-mutilation”)
- presence of wound, joint dislocation, fracture or more then one injury
- daily use of paracetamol and/or NSAID’s and/or other analgesia within two weeks before presentation
- patients with chronic pain
- previous adverse reaction or known allergy to paracetamol, NSAID’s or omeprazol
- pregnancy
- previous gastro-intestinal hemorrhage or perforation after NSAID use
- active or recurrent peptic ulceration or peptic bleeding (2 or more evident episodes)
- previous exacerbation of asthma after use of NSAID’s or acetylsalicylic acid
- severe cardiac failure
- liver cirrhosis
- severe renal insufficiency (eGFR<30mL/min)
- bone marrow depression or blood dyscrasia (active or in past medical history)
- combined use of angiotensin converting enzyme inhibitors (or angiotensin receptor blockers) AND diuretics
- physical, visual or cognitive impairment or non-Dutch language speaking (unable to use NRS, pain diary or EQ5D questionnaire) |
- eerdere behandeling met pijnstillende medicatie voor hetzelfde letsel
- letsel door patient bewust toegebracht (automutilatie)
- aanwezigheid van wond, gewrichtsdislocatie of fractuur
- dagelijks gebruik van paracetamol en/of nsaid's en/of andere analgetica gedurende de 2 weken voor presentatie
- patienten met chronische pijn
- eerdere allergische reactie of overgevoeligheidsreactie op paracetamol, nsaid's of omeprazol
- zwangerschap
- eerdere gastro-intestinale bloeding of perforatie na gebruik NSAID's
- actief of terugkerend ulcus pepticum of gastro-intestinale bloeding (2 of meer episodes)
- eerdere astma aanval na gebruik van NSAID's of acetylsalicylzuur
- ernstig hartfalen
- levercirrose
- ernstige nierinsufficientie (eGFR<30mL/min)
- beenmerg depressie of bloed dyscrasie (actief of in de medische voorgeschiedenis)
- gecombineerd gebruik van angiotensin converting enzyme inhibitors (ACE-remmers) of angtiotensine receptor blokkers EN diuretica
- fysieke, visuele of cognitieve beperking of niet-Nederlands sprekend (niet in staat tot het uitvoeren van NRS pijnscores in het pijndagboek of het invullen van de EQ5D vragenlijst) |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary outcome is decrease in pain, measured by differences in Numeric Rating Scales (NRS). A decrease of 1.3 in NRS is considered clinically relevant. This analgesic effectiveness will be monitored by repetitive measurements of pain scores using the NRS during the stay in the emergency department or during the visit to the general practitioner. After discharge, pain is measured and documented during three consecutive days in the home environment. |
De primaire uitkomst is vermindering in pijn, gemeten in verschillen in Numerical Rating Scales (NRS). Een vermindering van 1.3 in NRS wordt beschouwd als klinisch relevant. Deze analgetische effectiviteit zal gemonitored worden door herhaaldelijke metingen van pijn, gebruik makend van de NRS, gedurende het verblijf van de proefpersoon op de afdeling Spoedeisende Hulp of de huisartsenpraktijk. Na ontslag zal pijn gemeten en gedocumenteerd worden gedurende drie dagen in de thuissituatie. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Primary outcome will be measured at 90 minutes after administration of the study drugs |
De primaire uitkomst zal 90 minuten na toediening studiemedicatie worden gemeten |
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E.5.2 | Secondary end point(s) |
Secondary outcomes are occurrence of adverse events after use of pain medication.The safety profile of the different drugs involved will be investigated by monitoring the occurrence of adverse events in the emergency department or general practice and during a period of three days after discharge. Other secondary outcomes are patient satisfaction about pain relief, need for additional pain medication and cost-effectiveness of the different pain management strategies.
Special attention is given to the group of patients older then 60 years (block-randomization), as these patients have the highest risk of having NSAID-related adverse events. |
Secundaire uitkomsten zijn het optreden van bijwerkingen na het gebruik van de studiemedicatie. Het veiligheidsprofiel van de verschillende medicijnen zal worden onderzocht door middel van het monitoren van het optreden van bijwerkingen in de huisartsenpraktijk en op de afdeling spoedeisende hulp en gedurende de drie dagen hierna in de thuissituatie. Andere secundaire uitkomsten zijn patienttevredenheid over de pijnbestrijding, behoefte aan additionele pijnmedicatie en kosten-effectiviteitsanalyse van de verschillende pijnbehandelingsstrategieen. Als onderdeel hiervan zal de EQ5D vragenlijst worden ingevuld. Speciale aandacht wordt besteed aan de groep patiënten ouder dan 60 jaar (blok-randomisatie), gezien deze patiënten hoger risico lopen op NSAID-gerelateerde bijwerkingen. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
- during stay at emergency department or in general practice at 30 and 60 minutes
- by using a pain diary at home during three consecutive days after discharge, measuring pain with NRS three times daily (as well as occurrence of adverse events)
- EQ5D questionnaire once daily during these three days and a final measurement one month after inclusion
- patient satisfaction at discharge from emergency department or general practice and after three days at home |
- gedurende verblijf op SEH of bij huisarts na 30 of 60 minuten
- door middel van gebruik van pijndagboekjes in de thuissituatie gedurende drie dagen na ontslag, de patienten meten zelf de pijn met NRS drie keer per dag (evenals het eventuele optreden van bijwerkingen)
- EQ5D vragenlijst, wordt dagelijks ingevuld gedurende de drie dagen na ontslag en eenmaal 1 maand na inclusie |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Paracetamol vs Diclofenac vs Paracetamol + Diclofenac |
Paracetamol vs Diclofenac vs Paracetamol + Diclofenac |
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E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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LVLS |
Laatste bezoek (telefonisch) contact laatst geincludeerde proefpersoon |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | 0 |