The Efficacy of Solifenacin Succinate as Adjuvant Therapy... | NCT02094703

Studies
The Efficacy of Solifenacin Succinate as Adjuvant Therapy for Urinary Tract Infection in Females

NCT02094703

Sponsor

Dr Cipto Mangunkusumo General Hospital

Status

Unknown status

Last Update Posted

Mar 24, 2014Estimated

Enrollment

126Estimated

Phase

Phase 4

Conditions

Urinary Tract Infection

Interventions

Levofloxacin
Solifenacin succinate
Placebo (for Solifenacin succinate)

Countries

Indonesia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2013

Primary Completion Date

Nov 2014Estimated

Completion Date

Dec 2014Estimated

First Submitted Date

Mar 10, 2014

First Submission Date that Met QC Criteria

Mar 19, 2014

First Posted Date

Mar 24, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 19, 2014

Last Update Posted Date

Mar 24, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Harrina Erlianti Rahardjo,MD,PhD, MD, PhD, Dr Cipto Mangunkusumo General HospitalPrincipal Investigator

Lead Sponsor

Dr Cipto Mangunkusumo General HospitalOTHER

Collaborators

Name	Class
Astellas Pharma Indonesia Inc.	INDUSTRY
Pharos Life Corporation	INDUSTRY

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

126Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
levofloxacin and solifenacin succinate	Experimental	Levofloxacin 500 mg tablet and solifenacin succinate 5 mg tablet by mouth once daily for 3 days	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	Drug: Levofloxacin Drug: Placebo (for Solifenacin succinate)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Levofloxacin	Drug		levofloxacin and placebo levofloxacin and solifenacin succinate	neslav

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of participants with storage symptoms		up to three days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

females (18-65 years old)
dysuria in symptomatic non complicated urinary tract infection

Exclusion Criteria:

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
Catheter-mounted
Neurological diseases/disorders
patients with allergy/hypersensitivity with Levofloxacin/Solifenacin

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cipto Mangunkusumo Hospital	Recruiting	Jakarta	Jakarta Special Capital Region	10430	Indonesia

Condition Browse Module

MeSH Terms

ID	Term
D014552	Urinary Tract Infections

Ancestor Terms

ID	Term
D007239	Infections
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D064704	Levofloxacin
D000069464	Solifenacin Succinate

Ancestor Terms

ID	Term
D015242	Ofloxacin
D024841	Fluoroquinolones
D042462	4-Quinolones
D015363	Quinolones

Browse Leaves

Not provided

Browse Branches

Not provided