Clinical Trials Register

Summary
EudraCT Number:	2012-002776-14
Sponsor's Protocol Code Number:	2012-002776-14
National Competent Authority:	Sweden - MPA
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2013-12-13
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Sweden - MPA

A.2

EudraCT number

2012-002776-14

A.3

Full title of the trial

Ibuprofen versus mecillinam for uncomplicated cystitis in adult, non-pregnant women

Ibuprofen versus mecillinam vid behandling av okomplicerad cystit hos vuxna ej-gravida kvinnor

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Treatment of cystitis in adult, non-pregnant women

Behandling av cystit hos ej-gravida kvinnor

A.4.1

Sponsor's protocol code number

2012-002776-14

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	University of Oslo, Faculty of medicine, Institute of Health and Society
B.1.3.4	Country	Norway
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	The Norwegian Research Council
B.4.2	Country	Norway
B.4.1	Name of organisation providing support	The National Centre of Emergency Primary Health Care
B.4.2	Country	Norway
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	University of Oslo
B.5.2	Functional name of contact point	Ingvild Vik
B.5.3	Address:
B.5.3.1	Street Address	Antibiotic Center of Primary Care
B.5.3.2	Town/ city	P.o. box 1130, Blindern, Oslo
B.5.3.3	Post code	0318
B.5.3.4	Country	Norway
B.5.4	Telephone number	004723487000
B.5.6	E-mail	ingvild.vik@medisin.uio.no

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Ibuprofen ratiopharm
D.2.1.1.2	Name of the Marketing Authorisation holder	Ratiopharm
D.2.1.2	Country which granted the Marketing Authorisation	Norway
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Ibuprofen
D.3.4	Pharmaceutical form	Capsule
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Gastroenteral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	IBUPROFEN
D.3.9.1	CAS number	15687-27-1
D.3.9.4	EV Substance Code	SUB08098MIG
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Selexid
D.2.1.1.2	Name of the Marketing Authorisation holder	Leo Pharma
D.2.1.2	Country which granted the Marketing Authorisation	Norway
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Capsule
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Gastroenteral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	32886-97-8
D.3.9.3	Other descriptive name	PIVMECILLINAM HYDROCHLORIDE
D.3.9.4	EV Substance Code	SUB03884MIG
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

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

E.1.1.1

Medical condition in easily understood language

Cystitis in women

Cystit hos kvinnor

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

E.1.3

Condition being studied is a rare disease

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.

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

E.2.3

Trial contains a sub-study

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.

Kvinnor mellan 18 och 60år, med dysuri och polakisuri och/eller frekventa trängningar, förmåga att förstå svenska språket samt ge skrivet samtycke

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

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

E.5.1.1

Timepoint(s) of evaluation of this end point

Four days

Fyra dagar

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

E.5.2.1

Timepoint(s) of evaluation of this end point

Four weeks

Fyra veckor

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

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

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

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

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

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

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.

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)

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

140

F.4.2.2

In the whole clinical trial

400

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

None

Ingen

G. Investigator Networks to be involved in the Trial
G.4 Investigator Network to be involved in the Trial: 1
G.4.1	Name of Organisation	EMA Oslo
G.4.3.4	Network Country	Norway
G.4 Investigator Network to be involved in the Trial: 2
G.4.1	Name of Organisation	EMA Bergen
G.4.3.4	Network Country	Norway
G.4 Investigator Network to be involved in the Trial: 3
G.4.1	Name of Organisation	University of Copenhagen, Dept of General Practice
G.4.3.4	Network Country	Denmark
G.4 Investigator Network to be involved in the Trial: 4
G.4.1	Name of Organisation	University of Lund, Dept of General Practice SUS, Malmö, CRC
G.4.3.4	Network Country	Sweden

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2014-04-02

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2014-03-04

P. End of Trial
P.	End of Trial Status	Completed

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