Acute Cystitis (Excl in Pregnancy)Phase 4IMUTINCT01849926
Ibuprofen Versus Mecillinam for Uncomplicated Cystitis
A Phase 4 study testing Ibuprofen and Mecillinam in people with Acute Cystitis (Excl in Pregnancy), run by University of Oslo at 1 site in Norway.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Acute Cystitis (Excl in Pregnancy)
- What is being tested?
- Ibuprofen and Mecillinam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 383 participants
- Where
- 1 siteNorway
- Study dates
- Apr 2013to Jul 2016
- 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 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- woman between 18 and 60 years of age
- dysuria and pollakiuria and/or urinary urgency
- ability to give written consent
Who cannot join
- pregnancy/breastfeeding child under one month of age
- diabetes
- kidney disease
- organic aciduria
- clinical suspicion of pyelonephritis; fever, reduced general condition, upper back pain
- vaginal symptoms such as discharge or irritation
Show all 27Show fewer
- 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
- participated in a clinical trial within the last four weeks
- previously undergone a pyelonephritis
- previous allergic reaction to penicillin
- previous allergic reaction to ibuprofen, or worsening of asthma when using nonsteroidal antiinflammatory drugs(NSAIDs)
- narrow oesophagus
- use of the drug probenecid
- severe gastritis or previous ulcer
- anticoagulative treatment
- ongoing use of steroids
- use of immunosuppressant drugs
- thrombocytopenia,
- Chrohn's disease or Ulcerative colitis
- heart insufficiency
- severe psychiatric illness or dementia
- severe drug addiction
- unable to communicate in Norwegian, Swedish or Danish language
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ibuprofen Versus Mecillinam for Uncomplicated Cystitis in Adult, Non-pregnant Women
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 efficient as treatment with mecillinam in this group.
Read the detailed description
The design of the study will be a double blinded randomized controlled trial (RCT). Half of the patients will receive treatment with mecillinam and the other half will receive treatment with ibuprofen. The study will follow the principles of Good Clinical Practice (GCP).
Urine cultures will be obtained on day one and after two weeks. The patients will be given a diary where they daily will register symptom load, possible complications or adverse effects and on which day they feel completely cured. We will contact the patients after two weeks to make sure they have followed the study procedures. After four weeks we will perform a final interview with the patient.
- Conditions
- Acute Cystitis (Excl in Pregnancy)
- Being tested
- Ibuprofen, Mecillinam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbuprofenDrug
Also called Ibux
MecillinamDrug
Also called Selexid, Penomax
| Study group | Role | What they receive |
|---|---|---|
| Ibuprofen | Active comparator | Tablet, over capsulated, 600mg three times a day for three days. Receives: Drug: Ibuprofen |
| Mecillinam | Active comparator | Tablet, over capsulated, 200mg three times a day for three days. Receives: Drug: Mecillinam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who are symptom free by day four
Both symptom load with regard to specific symptoms and when feeling completely symptom free will be registered in the patient diary.
Measured: Four days
Secondary outcomes (1)
The patients' symptom load with regard to specific symptoms.
Specific symptoms, such as dysuria, urgency and pollakiuria, will be given a number from 0-6 in the patient diary, 0 = no problem and 6= as bad as it can get.
Measured: Seven days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2013 (estimated)
- Study startApr 2013
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute Cystitis (Excl in Pregnancy)Studies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 383 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bergen, Lund University, University of Copenhagen
- Responsible party
- Principal investigator, Morten Lindbaek, University of Oslo
- Investigators
- Morten Lindbæk, Professor, Principal investigator, University of Oslo, faculty of medicine, institute for health and society, department of general medicine, antibiotic centre of primary care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01849926
- Sponsor's protocol ID
- UiO_IMUTI
- Acronym
- IMUTI
- Status last verified
- Nov 2017
- First submitted
- 4 Apr 2013
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Sachdeva A, Rai BP, Veeratterapillay R, Harding C, Nambiar A. Non-steroidal anti-inflammatory drugs for treating symptomatic uncomplicated urinary tract infections in non-pregnant adult women. Cochrane Database Syst Rev. 2024 Dec 19;12(12):CD014762. doi: 10.1002/14651858.CD014762.pub2.
PubMed 39698942Vik I, Mdala I, Bollestad M, Cordoba GC, Bjerrum L, Neumark T, Damsgaard E, Baerheim A, Grude N, Lindbaek M. Predicting the use of antibiotics after initial symptomatic treatment of an uncomplicated urinary tract infection: analyses performed after a randomised controlled trial. BMJ Open. 2020 Aug 30;10(8):e035074. doi: 10.1136/bmjopen-2019-035074.
PubMed 32868350Vik I, Bollestad M, Grude N, Baerheim A, Damsgaard E, Neumark T, Bjerrum L, Cordoba G, Olsen IC, Lindbaek M. Ibuprofen versus pivmecillinam for uncomplicated urinary tract infection in women-A double-blind, randomized non-inferiority trial. PLoS Med. 2018 May 15;15(5):e1002569. doi: 10.1371/journal.pmed.1002569. eCollection 2018 May.
PubMed 29763434Vik I, Bollestad M, Grude N, Baerheim A, Molstad S, Bjerrum L, Lindbaek M. Ibuprofen versus mecillinam for uncomplicated cystitis--a randomized controlled trial study protocol. BMC Infect Dis. 2014 Dec 17;14:693. doi: 10.1186/s12879-014-0693-y.
PubMed 25516016
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ibuprofen Versus Mecillinam for Uncomplicated Cystitis in Adult, Non-pregnant Women
- ClinicalTrials.gov ID
- NCT01849926
- Acronym / sponsor ID
- IMUTI / UiO_IMUTI
- Conditions
- Acute Cystitis (Excl in Pregnancy)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 383 participants (actual)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Collaborators
- University of Bergen, Lund University, University of Copenhagen
- Study start
- Apr 2013
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 9 May 2013 (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.
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 efficient as treatment with mecillinam in this group.
Detailed description
The design of the study will be a double blinded randomized controlled trial (RCT). Half of the patients will receive treatment with mecillinam and the other half will receive treatment with ibuprofen. The study will follow the principles of Good Clinical Practice (GCP).
Urine cultures will be obtained on day one and after two weeks. The patients will be given a diary where they daily will register symptom load, possible complications or adverse effects and on which day they feel completely cured. We will contact the patients after two weeks to make sure they have followed the study procedures. After four weeks we will perform a final interview with the patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ibuprofen | Active comparator | Drug: IbuprofenTablet, over capsulated, 600mg three times a day for three days. |
| Mecillinam | Active comparator | Drug: MecillinamTablet, over capsulated, 200mg three times a day for three days. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- woman between 18 and 60 years of age
- dysuria and pollakiuria and/or urinary urgency
- ability to give written consent
Key exclusion criteria (27 listed)
- pregnancy/breastfeeding child under one month of age
- diabetes
- kidney disease
- organic aciduria
- clinical suspicion of pyelonephritis; fever, reduced general condition, upper back pain
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 |
|---|---|---|
| IbuprofenAlso: Ibux | Drug | Ibuprofen |
| MecillinamAlso: Selexid, Penomax | Drug | Mecillinam |
Primary outcome
Number of patients who are symptom free by day four
Time frame: Four days
Both symptom load with regard to specific symptoms and when feeling completely symptom free will be registered in the patient diary.
1 secondary outcome
The patients' symptom load with regard to specific symptoms.
Time frame: Seven days
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 Nov 2017.
- Derived from this study: PubMed 39698942Sachdeva A, Rai BP, Veeratterapillay R, Harding C, Nambiar A. Non-steroidal anti-inflammatory drugs for treating symptomatic uncomplicated urinary tract infections in non-pregnant adult women. Cochrane Database Syst Rev. 2024 Dec 19;12(12):CD014762. doi: 10.1002/14651858.CD014762.pub2.
- Derived from this study: PubMed 32868350Vik I, Mdala I, Bollestad M, Cordoba GC, Bjerrum L, Neumark T, Damsgaard E, Baerheim A, Grude N, Lindbaek M. Predicting the use of antibiotics after initial symptomatic treatment of an uncomplicated urinary tract infection: analyses performed after a randomised controlled trial. BMJ Open. 2020 Aug 30;10(8):e035074. doi: 10.1136/bmjopen-2019-035074.
- Derived from this study: PubMed 29763434Vik I, Bollestad M, Grude N, Baerheim A, Damsgaard E, Neumark T, Bjerrum L, Cordoba G, Olsen IC, Lindbaek M. Ibuprofen versus pivmecillinam for uncomplicated urinary tract infection in women-A double-blind, randomized non-inferiority trial. PLoS Med. 2018 May 15;15(5):e1002569. doi: 10.1371/journal.pmed.1002569. eCollection 2018 May.
- Derived from this study: PubMed 25516016Vik I, Bollestad M, Grude N, Baerheim A, Molstad S, Bjerrum L, Lindbaek M. Ibuprofen versus mecillinam for uncomplicated cystitis--a randomized controlled trial study protocol. BMC Infect Dis. 2014 Dec 17;14:693. doi: 10.1186/s12879-014-0693-y.
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.
Morten Lindbæk, Professor principal investigator
University of Oslo, faculty of medicine, institute for health and society, department of general medicine, antibiotic centre of primary care
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 Ibuprofen and Mecillinam in people with Acute Cystitis (Excl in Pregnancy), run by University of Oslo at 1 site in Norway.
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 27 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 Nov 2017. 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 Norway. 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?
Number of patients who are symptom free by day four (time frame: Four days). 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 NCT01849926, which also lists 4 linked publications.
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 Nov 2017.