Urinary Tract InfectionPhase 4NCT02094703
The Efficacy of Solifenacin Succinate as Adjuvant Therapy for Urinary Tract Infection in Females
A Phase 4 study testing Levofloxacin and Solifenacin succinate in people with Urinary Tract Infection, run by Dr Cipto Mangunkusumo General Hospital at 1 site in Indonesia.
Trial summary
The efficacy of Solifenacin Succinate 5 mg as adjuvant therapy and levofloxacin (500 mg) for short-term treatment to reduce symptoms in patients with symptomatic non complicated urinary tract infection in females. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Urinary Tract Infection
- What is being tested?
- Levofloxacin and Solifenacin succinate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 1 siteIndonesia
- Study dates
- Apr 2013to Dec 2014
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- females (18-65 years old)
- dysuria in symptomatic non complicated urinary tract infection
Who cannot join
- Pediatric Patients (< 18 years old)
- geriatric Patients (> 65 years old)
- pregnant Patients
- Patients with complicated urinary tract infection
- sexually transmitted infections
- Patients with pathological abnormalities in the urinary bladder, including stone/mass
Show all 9Show fewer
- Catheter-mounted
- Neurological diseases/disorders
- patients with allergy/hypersensitivity with Levofloxacin/Solifenacin
Trial locations and contacts
1 site in 1 country.
Indonesia1 site, 1 recruiting
- Recruiting
Cipto Mangunkusumo Hospital
Jakarta, Jakarta Special Capital Region, 10430
Harrina Erlianti Rahardjo, +62 816-825-226, harrinaerlianti@yahoo.com
About this study
Official title: The Efficacy of Solifenacin Succinate as Adjuvant Therapy for Symptomatic Non-complicated Urinary Tract Infection in Females
The efficacy of Solifenacin Succinate 5 mg as adjuvant therapy and levofloxacin (500 mg) for short-term treatment to reduce symptoms in patients with symptomatic non complicated urinary tract infection in females.
- Conditions
- Urinary Tract Infection
- Being tested
- Levofloxacin, Solifenacin succinate, Placebo (for Solifenacin succinate)
- Keywords
- female, age 18-65 years, storage symptoms, clinical urinary tract infection, non complicated
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevofloxacinDrug
Also called neslav
Solifenacin succinateDrug
Placebo (for Solifenacin succinate)Drug
| Study group | Role | What they receive |
|---|---|---|
| levofloxacin and solifenacin succinate | Experimental | Levofloxacin 500 mg tablet and solifenacin succinate 5 mg tablet by mouth once daily for 3 days Receives: Drug: Levofloxacin; Drug: Solifenacin succinate |
| levofloxacin and placebo | Active comparator | Levofloxacin 500 mg tablet and placebo (for solifenacin succinate) by mouth once daily for 3 days Receives: Drug: Levofloxacin; Drug: Placebo (for Solifenacin succinate) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with storage symptoms
Measured: up to three days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2014 (estimated)
- Study startApr 2013
- Primary completionNov 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr Cipto Mangunkusumo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Astellas Pharma Indonesia Inc., Pharos Life Corporation
- Responsible party
- Principal investigator, Harrina Erlianti Rahardjo,MD,PhD, Dr Cipto Mangunkusumo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02094703
- Sponsor's protocol ID
- URO-SOL-01-2012
- Status last verified
- Mar 2014
- First submitted
- 10 Mar 2014
- Last updated
- 24 Mar 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Solifenacin Succinate as Adjuvant Therapy for Symptomatic Non-complicated Urinary Tract Infection in Females
- ClinicalTrials.gov ID
- NCT02094703
- Acronym / sponsor ID
- URO-SOL-01-2012
- Conditions
- Urinary Tract Infection
- Keywords
- female, age 18-65 years, storage symptoms, clinical urinary tract infection, non complicated
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Dr Cipto Mangunkusumo General HospitalUniversity, hospital or other
- Collaborators
- Astellas Pharma Indonesia Inc., Pharos Life Corporation
- Study start
- Apr 2013
- Primary completion
- Nov 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 24 Mar 2014 (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 efficacy of Solifenacin Succinate 5 mg as adjuvant therapy and levofloxacin (500 mg) for short-term treatment to reduce symptoms in patients with symptomatic non complicated urinary tract infection in females.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| levofloxacin and solifenacin succinate | Experimental | Drug: Levofloxacin, Drug: Solifenacin succinateLevofloxacin 500 mg tablet and solifenacin succinate 5 mg tablet by mouth once daily for 3 days |
| levofloxacin and placebo | Active comparator | Drug: Levofloxacin, Drug: Placebo (for Solifenacin succinate)Levofloxacin 500 mg tablet and placebo (for solifenacin succinate) by mouth once daily for 3 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- females (18-65 years old)
- dysuria in symptomatic non complicated urinary tract infection
Key exclusion criteria (9 listed)
- Pediatric Patients (< 18 years old)
- geriatric Patients (> 65 years old)
- pregnant Patients
- Patients with complicated urinary tract infection
- sexually transmitted infections
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 |
|---|---|---|
| LevofloxacinAlso: neslav | Drug | levofloxacin and placebo, levofloxacin and solifenacin succinate |
| Solifenacin succinate | Drug | levofloxacin and solifenacin succinate |
| Placebo (for Solifenacin succinate) | Drug | levofloxacin and placebo |
Primary outcome
Number of participants with storage symptoms
Time frame: up to three days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2014.
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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.
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 Levofloxacin and Solifenacin succinate in people with Urinary Tract Infection, run by Dr Cipto Mangunkusumo General Hospital at 1 site in Indonesia.
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 2 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 24 Mar 2014. 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 Indonesia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with storage symptoms (time frame: up to three days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Mar 2014.