E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Uncomplicated cystitis in adult, non pregnant women, age 18-60. |
Okomplicerad cystit hos vuxna ej-gravida kvinnor i åldrarna 18-60 |
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E.1.1.1 | Medical condition in easily understood language |
Cystitis in women |
Cystit hos kvinnor |
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E.1.1.2 | Therapeutic area | Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10000699 |
E.1.2 | Term | Acute cystitis (excl in pregnancy) |
E.1.2 | System Organ Class | 100000004862 |
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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 |
Although uncomplicated cystitis is considered to be a mild condition and mostly self limiting, most patients who see a doctor will be treated with antibiotics. Antibiotics are known to give a quick relief of symptoms and shorten the course of the condition by a few days.
The aim of this study is to evaluate ibuprofen versus mecillinam in the treatment of uncomplicated cystitis in otherwise healthy, non-pregnant women.
Our main objective is to see whether symptomatic treatment with ibuprofen is equally efficiant as treatment with mecillinam in this group. |
Okomplicerad cystit anses vara en mild och självläkande åkomma, trotts detta behandlas de flesta kvinnor som uppsöker läkare med antibiotika. Antibiotika brukar resultera i snabb symptomlindring samt förkortar tiden med symptom.
Syftet med denna studie är att utvärdera effekten av ibuprofen versus mecillinam vid behandling av akut okomplicerad cystit hos vuxna, icke gravida kvinnor. Vi önskar att se om ibuprofen utgör ett likvärdigt behandlingsalternativ till mecillinam i denna patientgrupp.
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E.2.2 | Secondary objectives of the trial |
Will it take longer for the patients in the ibuprofen group to feel well? Are there more complications in the ibuprofen group compared to the mecillinam group? Are they more likely to develop an upper urinary tract infection? Are they more likely to develop a second uncomplicated cystitis within the four weeks of follow up? Are there more positive urine cultures in the ibuprofen group after two weeks? |
Tar det längre tid för patienterna i ibuprofengruppen att känna sig återställda? Finns där flera komplikationer i ibuprofengruppen jämfört med mecilinamgruppen? Har patienter i Ibuprofengruppen en ökad risk för att utveckla övre urinvägsinfektion? Eller en ökad risk för att utveckla ny okomplicerad cystit under uppföljningsperioden (4 veckor)? Är positiva kontrollodlingar (14 dagar) överrepresenterade i ibuprofengruppen |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Woman between 18 and 60 years of age.
Dysuria and urinary frequency and/or urinary urgency.
Ability to speak, understand and write Norwegian/Swedish/Danish and ability to give consent.
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Kvinnor mellan 18 och 60år, med dysuri och polakisuri och/eller frekventa trängningar, förmåga att förstå svenska språket samt ge skrivet samtycke
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E.4 | Principal exclusion criteria |
Pregnancy/breastfeeding child under one month of age
Diabetes
Kidney disease or use of the drug probenecid
Clinical suspicion of pyelonefritis; fever, reduced general condition, upper back pain
Vaginal symptoms such as discharge or irritation
Severe abdominal pain
Symptoms that have lasted for more than seven days
One or more urinary tract infections within the lasts four weeks
Permanent bladder catheter or use of bladder catheter within the last four weeks
Use of antibiotics within the last two weeks
Previous allergic reaction to penicillin
Previous allergic reaction to ibuprofen, or worsening of asthma when taking NSAIDs
Narrow oesophagus
Severe gastritis or previous ulcer
Anticoagulative treatment
Ongoing use of steroids
Use of immunosuppressant drugs
Thrombocytopenia
Heart insufficiency
Severe psychiatric illness or dementia
Severe drug addiction
Unable to communicate in Norwegian, Swedish or Danish language |
Graviditet/amning av barn <1månad, diabetes, njursjukdom, genetisk aciduri, kliniks misstanke om njurbäckeninflammation, vaginala symptom såsom riklig flytning eller irritation, svår buksmärta, symptom > 7 dagar, urinvägsinfektion under de senaste 4 veckorna, permanent KAD eller KAD under de senaste 14 dagarna, antibiotika behandling under de senaste 2 veckorna, deltagande i annan klinisk studie under de 2 veckorna, tidigare njurbäckeninflammation, tidigare penicillinallergi, tidigare allergi mot ibuprofen eller försämring av astma på NSAID, esophagusstriktur, svår gastritt eller tidigare ulcus, pågående Probecid, kortison, Waran eller immunosupressivbehandling, trombocytopeni, ulcerös kolit samt Mb.Crohn, hjärtsvikt, svår psykisk åkomma eller demens, narkotikamissbruk, bristande kunskaper i svenska språket |
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E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of patients who feel cured by day four as registered in the patient diary |
Andelen patienter som i dagböckerna uppgav att de kände sig återställda dag 4 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
The patients’ symptom load with regard to specific symptoms.
Proportion of patients who had a relapse of symptoms of uncomplicated cystitis within the study period.
Proportion of patients who were in need of a secondary medical consult within the study period.
Proportion of patients who developed an upper urinary tract infection (pyelonefritis).
Proportion of patients who experienced severe adverse effects.
Proportion of patients with a positive urine culture after two weeks. |
Patienternas symptomtyngd med avseende på specifika symptom
Andelen patienter som upplevd återfall av cystitsymptom under studietiden
Andelen patienter som sökt läkare för urinvägsrelaterade symptom under studietiden.
Andelen patienter som utvecklad en övre urinvägsinfektion(pyelonefritt)
Andelen patienter med upplevda allvarliga biverkningar
Andelen patienter med positiv urinodling efter 14 dagar
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
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 | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 2 |
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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We will end the trial when a sufficient number of patients have been included according to the power calculation, i.e. 400 patients in total, 200 in Oslo and 70at each of the other three study sites. End of trial is four weeks after the visit of the last subject undergoing the trial since the follow up of the subject is four weeks after inclusion in the trial.
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Vi avslutar studien när tillräckligt antal patienter inkluderats - enligt Powerberäkningen behöver 400 patienter inkluderas; 200 patienter i Oslo, och ca 200 från de övriga inkluderande studiecentra i Norge, Danmark samt Sverige. Datainsamlingen avslutas 4 veckor efter den senast inkluderade patienten (efter den senast inkluderade 4 -veckors kontroll) |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |