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A Study to Investigate the Efficacy and Safety With Gepotidacin in Japanese Female Participants With Uncomplicated Urinary Tract Infection (Acute Cystitis) (EAGLE-J)

Primary Purpose

Urinary Tract Infections

Status
Recruiting
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Gepotidacin
Nitrofurantoin
Placebo
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Tract Infections focused on measuring Acute cystitis, Efficacy, Gepotidacin, Nitrofurantoin, Urinary Tract Infection, Japanese Female

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: The participant has a body weight >=40 kilograms (kg). The participant has 2 or more of the following clinical signs and symptoms of acute cystitis with onset less than (<) 96 hours prior to study entry: dysuria, frequency, urgency, or lower abdominal pain. The participant has nitrite or pyuria (greater than [>]15 white blood cell [WBC]/high-power field [HPF] or the presence of 3 plus (+) /large leukocyte esterase) from a pretreatment clean-catch midstream urine sample based on local laboratory procedures. The participant is capable of giving signed informed consent/assent. Exclusion Criteria: The participant resides in a nursing home or dependent care type facility. The participant has a body mass index >=40.0 kilogram per meter square (kg/m^2) or a body mass index >=35.0 kg/m^2 and is experiencing obesity-related health conditions such as uncontrolled high blood pressure or uncontrolled diabetes. The participant is immunocompromised or has altered immune defenses that may predispose the participant to a higher risk of treatment failure and/or complications. The participant has any of the following: Poorly controlled asthma or chronic obstructive pulmonary disease; Acute severe pain; Active peptic ulcer disease; Parkinson disease; Myasthenia gravis; a history of seizure disorder requiring medications for control (this does not include a history of childhood febrile seizures); Or Known acute porphyria. Any surgical or medical condition (active or chronic) that may interfere with drug absorption, distribution, metabolism, or excretion of the study intervention. The participant has a known glucose-6-phosphate dehydrogenase deficiency. The participant, in the judgment of the investigator, would not be able or willing to comply with the protocol or complete study follow-up. The participant has acute uncomplicated cystitis that is known or suspected to be due to fungal, parasitic, or viral pathogens; or known or suspected to be due to Pseudomonas aeruginosa or Enterobacterales (other than E. coli) as the contributing pathogen. The participant has symptoms known or suspected to be caused by another disease process, such as asymptomatic bacteriuria, overactive bladder, chronic incontinence, or chronic interstitial cystitis, that may interfere with the clinical efficacy assessments or preclude complete resolution of acute cystitis symptoms. The participant has an anatomical or physiological anomaly that predisposes the participant to UTIs or may be a source of persistent bacterial colonization, including calculi, obstruction or stricture of the urinary tract, primary renal disease (e.g., polycystic renal disease), or neurogenic bladder, or the participant has a history of anatomical or functional abnormalities of the urinary tract (e.g., chronic vesicoureteral reflux, detrusor insufficiency). The participant has an indwelling catheter, nephrostomy, ureter stent, or other foreign material in the urinary tract. The participant who, in the opinion of the investigator, has an otherwise complicated UTI, an active upper UTI (e.g., pyelonephritis, urosepsis), signs and symptom onset >=96 hours before study entry, or a temperature >=38 Degrees Celsius [°C], flank pain, chills, or any other manifestations suggestive of upper UTI. The participant has known anuria, oliguria, or significant impairment of renal function (creatinine clearance <60 milliliters per minute (mL/min) or clinically significant elevated serum creatinine as determined by the investigator). The participant presents with vaginal discharge at Baseline (e.g., suspected sexually transmitted disease). The participant has congenital long QT syndrome or known prolongation of the corrected QT (QTc) interval. The participant has uncompensated heart failure. The participant has severe left ventricular hypertrophy. The participant has a family history of QT prolongation or sudden death. The participant has a recent history of vasovagal syncope or episodes of symptomatic bradycardia or brady arrhythmia within the last 12 months. The participant is taking QT-prolonging drugs or drugs known to increase the risk of torsades de pointes (TdP) per the www.crediblemeds.org. "Known Risk of TdP" category at the time of her Baseline Visit, which cannot be safely discontinued from the Baseline Visit to the TOC Visit; or the participant is taking a strong cytochrome P450 enzyme 3A4 (CYP3A4) inhibitor. For any participant >=12 to <18 years of age, the participant has an abnormal ECG reading at Baseline. The participant has a QTc >450 msec or a QTc >480 msec for participants with bundle branch block. The participant has a documented or recent history of uncorrected hypokalemia within the past 3 months. The participant has a known alanine aminotransferase (ALT) value >2 times upper limit of normal (ULN). The participant has a known total bilirubin value >1.5 times ULN (isolated bilirubin >1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin <35 percent [%]). The participant has cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice. The participant has a previous history of cholestatic jaundice/hepatic dysfunction associated with nitrofurantoin. The participant has received treatment with other systemic antimicrobials or systemic antifungals within 1 week before study entry.

Sites / Locations

  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Gepotidacin + Placebo

Nitrofurantoin + Placebo

Arm Description

Outcomes

Primary Outcome Measures

Number of participants with therapeutic response (combined per participant clinical and microbiological response) at the TOC Visit
A therapeutic success refers to participants who have been deemed both a "microbiological success" (reduction of all qualifying bacterial uropathogens [greater than or equal to {>=}10^5 colony-forming units per milliliter {CFU/mL}] recovered at Baseline to less than (<)10^3 CFU/mL as observed on quantitative urine culture without the participant receiving other systemic antimicrobials at the TOC Visit) and a "clinical success" (resolution of signs and symptoms of acute cystitis present at Baseline [and no new signs and symptoms] without the participant receiving other systemic antimicrobials at the TOC Visit). All other combinations (other than clinical success + microbiological success) are deemed failures for therapeutic response.

Secondary Outcome Measures

Number of participants with therapeutic response to gepotidacin compared to nitrofurantoin at the TOC Visit
Number of participants with clinical outcome and response at the TOC visit
Clinical success (response) is defined as clinical resolution. Clinical resolution (outcome) is defined as resolution of signs and symptoms of acute cystitis present at Baseline (and no new signs and symptoms) without the participant receiving other systemic antimicrobials.
Number of participants with per participant microbiological outcome and response at the TOC visit
Participant-level microbiological success (response) is defined as microbiological eradication. Microbiological eradication (outcome) is defined as reduction of all qualifying bacterial uropathogens [>=10^5 CFU/mL] recovered at Baseline to <10^3 CFU/mL as observed on quantitative urine culture without the participant receiving other systemic antimicrobials.
Number of participants with therapeutic response in female participants with acute uncomplicated cystitis who have qualifying uropathogen(s) resistant to two or more specific classes of antimicrobials
Number of participants with clinical outcome and response in female participants with acute uncomplicated cystitis who have qualifying uropathogen(s) resistant to two or more specific classes of antimicrobials
Number of participants with microbiological outcome and response in female participants with acute uncomplicated cystitis who have qualifying uropathogen(s) resistant to two or more specific classes of antimicrobials
Number of participants with Investigator assessment of clinical response at the TOC Visit
Number of participants with Treatment-Emergent Adverse Events (TEAEs)
Number of participants with Serious Adverse Events (SAEs)
Number of participants with Adverse Events of Special Interest (AESIs)
Change from baseline in hematology parameters: neutrophil count, lymphocyte count, monocyte count, eosinophil count, basophil count and platelet count (Giga cells per liter)
Change from baseline in hematology parameter: Red Blood Cell (RBC) count (Trillion cells per liter)
Change from baseline in hematology parameter: Hemoglobin (Hb) (Grams per liter)
Change from baseline in hematology parameter: Hematocrit (Proportion of red blood cells in blood)
Change from baseline in hematology parameter: Mean Corpuscular Volume (MCV) (Femtoliters)
Change from baseline in hematology parameter: Mean Corpuscular Hemoglobin (MCH) (Picograms)
Change from baseline in clinical chemistry parameters: Blood urea nitrogen [BUN], glucose [non-fasting], calcium, chloride, sodium, magnesium, phosphate, and potassium levels (Millimoles per liter)
Change from baseline in clinical chemistry parameters: Total bilirubin, direct bilirubin and creatinine levels (Micromoles per liter)
Change from baseline in clinical chemistry parameters: albumin and total protein levels (Gram per liter)
Change from baseline in clinical chemistry parameters: Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase levels (International units per liter)
Change from Baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) (Millimeters of mercury [mmHg])
Change from baseline in pulse rate (Beats per minute)
Change from baseline in body temperature (Degrees Celsius)
Change from baseline in heart rate (Beats per minute)
Change from baseline in electrocardiogram parameters: PR Interval, QRS Duration, QT Interval, QT interval corrected for heart rate according Fridericia's formula (QTcF) and Bazett's formula (QTcB) (Milliseconds [msec])
Plasma concentration of gepotidacin
Urine concentration of gepotidacin

Full Information

First Posted
November 23, 2022
Last Updated
February 9, 2023
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT05630833
Brief Title
A Study to Investigate the Efficacy and Safety With Gepotidacin in Japanese Female Participants With Uncomplicated Urinary Tract Infection (Acute Cystitis)
Acronym
EAGLE-J
Official Title
A Phase III, Multicenter, Randomized, Active Reference, Double Blind, Double-dummy Study in Japanese Female Participants to Evaluate the Efficacy and Safety of Gepotidacin in the Treatment of Uncomplicated Urinary Tract Infection (Acute Cystitis)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 11, 2023 (Actual)
Primary Completion Date
September 11, 2023 (Anticipated)
Study Completion Date
October 9, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the consistency of therapeutic response of gepotidacin at the Test of cure (TOC) Visit (Days 10 to 13) in female participants with acute uncomplicated cystitis with qualifying bacterial uropathogen(s) at baseline that all are susceptible to nitrofurantoin in Japan, with that from global studies (Studies 204989 [NCT04020341] and 212390 [NCT04187144]).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infections
Keywords
Acute cystitis, Efficacy, Gepotidacin, Nitrofurantoin, Urinary Tract Infection, Japanese Female

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Gepotidacin + Placebo
Arm Type
Experimental
Arm Title
Nitrofurantoin + Placebo
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Gepotidacin
Intervention Description
Gepotidacin will be administered.
Intervention Type
Drug
Intervention Name(s)
Nitrofurantoin
Intervention Description
Nitrofurantoin will be administered.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo will be administered.
Primary Outcome Measure Information:
Title
Number of participants with therapeutic response (combined per participant clinical and microbiological response) at the TOC Visit
Description
A therapeutic success refers to participants who have been deemed both a "microbiological success" (reduction of all qualifying bacterial uropathogens [greater than or equal to {>=}10^5 colony-forming units per milliliter {CFU/mL}] recovered at Baseline to less than (<)10^3 CFU/mL as observed on quantitative urine culture without the participant receiving other systemic antimicrobials at the TOC Visit) and a "clinical success" (resolution of signs and symptoms of acute cystitis present at Baseline [and no new signs and symptoms] without the participant receiving other systemic antimicrobials at the TOC Visit). All other combinations (other than clinical success + microbiological success) are deemed failures for therapeutic response.
Time Frame
Days 10 to 13
Secondary Outcome Measure Information:
Title
Number of participants with therapeutic response to gepotidacin compared to nitrofurantoin at the TOC Visit
Time Frame
Days 10 to 13
Title
Number of participants with clinical outcome and response at the TOC visit
Description
Clinical success (response) is defined as clinical resolution. Clinical resolution (outcome) is defined as resolution of signs and symptoms of acute cystitis present at Baseline (and no new signs and symptoms) without the participant receiving other systemic antimicrobials.
Time Frame
Days 10 to 13
Title
Number of participants with per participant microbiological outcome and response at the TOC visit
Description
Participant-level microbiological success (response) is defined as microbiological eradication. Microbiological eradication (outcome) is defined as reduction of all qualifying bacterial uropathogens [>=10^5 CFU/mL] recovered at Baseline to <10^3 CFU/mL as observed on quantitative urine culture without the participant receiving other systemic antimicrobials.
Time Frame
Days 10 to 13
Title
Number of participants with therapeutic response in female participants with acute uncomplicated cystitis who have qualifying uropathogen(s) resistant to two or more specific classes of antimicrobials
Time Frame
Days 10 to 13
Title
Number of participants with clinical outcome and response in female participants with acute uncomplicated cystitis who have qualifying uropathogen(s) resistant to two or more specific classes of antimicrobials
Time Frame
Days 10 to 13
Title
Number of participants with microbiological outcome and response in female participants with acute uncomplicated cystitis who have qualifying uropathogen(s) resistant to two or more specific classes of antimicrobials
Time Frame
Days 10 to 13
Title
Number of participants with Investigator assessment of clinical response at the TOC Visit
Time Frame
Days 10 to 13
Title
Number of participants with Treatment-Emergent Adverse Events (TEAEs)
Time Frame
Up to Day 31
Title
Number of participants with Serious Adverse Events (SAEs)
Time Frame
Up to Day 31
Title
Number of participants with Adverse Events of Special Interest (AESIs)
Time Frame
Up to Day 31
Title
Change from baseline in hematology parameters: neutrophil count, lymphocyte count, monocyte count, eosinophil count, basophil count and platelet count (Giga cells per liter)
Time Frame
Baseline, On-Therapy (Days 2 to 4), and TOC (Days 10 to 13)
Title
Change from baseline in hematology parameter: Red Blood Cell (RBC) count (Trillion cells per liter)
Time Frame
Baseline, On-Therapy (Days 2 to 4), and TOC (Days 10 to 13)
Title
Change from baseline in hematology parameter: Hemoglobin (Hb) (Grams per liter)
Time Frame
Baseline, On-Therapy (Days 2 to 4), and TOC (Days 10 to 13)
Title
Change from baseline in hematology parameter: Hematocrit (Proportion of red blood cells in blood)
Time Frame
Baseline, On-Therapy (Days 2 to 4), and TOC (Days 10 to 13)
Title
Change from baseline in hematology parameter: Mean Corpuscular Volume (MCV) (Femtoliters)
Time Frame
Baseline, On-Therapy (Days 2 to 4), and TOC (Days 10 to 13)
Title
Change from baseline in hematology parameter: Mean Corpuscular Hemoglobin (MCH) (Picograms)
Time Frame
Baseline, On-Therapy (Days 2 to 4), and TOC (Days 10 to 13)
Title
Change from baseline in clinical chemistry parameters: Blood urea nitrogen [BUN], glucose [non-fasting], calcium, chloride, sodium, magnesium, phosphate, and potassium levels (Millimoles per liter)
Time Frame
Baseline, On-Therapy (Days 2 to 4), and TOC (Days 10 to 13)
Title
Change from baseline in clinical chemistry parameters: Total bilirubin, direct bilirubin and creatinine levels (Micromoles per liter)
Time Frame
Baseline, On-Therapy (Days 2 to 4), and TOC (Days 10 to 13)
Title
Change from baseline in clinical chemistry parameters: albumin and total protein levels (Gram per liter)
Time Frame
Baseline, On-Therapy (Days 2 to 4), and TOC (Days 10 to 13)
Title
Change from baseline in clinical chemistry parameters: Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase levels (International units per liter)
Time Frame
Baseline, On-Therapy (Days 2 to 4), and TOC (Days 10 to 13)
Title
Change from Baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) (Millimeters of mercury [mmHg])
Time Frame
Baseline, On-Therapy (Days 2 to 4), and TOC (Days 10 to 13)
Title
Change from baseline in pulse rate (Beats per minute)
Time Frame
Baseline, On-Therapy (Days 2 to 4), and TOC (Days 10 to 13)
Title
Change from baseline in body temperature (Degrees Celsius)
Time Frame
Baseline, On-Therapy (Days 2 to 4), and TOC (Days 10 to 13)
Title
Change from baseline in heart rate (Beats per minute)
Time Frame
Baseline, On-Therapy (Days 2 to 4), and TOC (Days 10 to 13)
Title
Change from baseline in electrocardiogram parameters: PR Interval, QRS Duration, QT Interval, QT interval corrected for heart rate according Fridericia's formula (QTcF) and Bazett's formula (QTcB) (Milliseconds [msec])
Time Frame
Baseline, On-Therapy (Days 2 to 4), and TOC (Days 10 to 13)
Title
Plasma concentration of gepotidacin
Time Frame
Up to Day 4
Title
Urine concentration of gepotidacin
Time Frame
Up to Day 4

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The participant has a body weight >=40 kilograms (kg). The participant has 2 or more of the following clinical signs and symptoms of acute cystitis with onset less than (<) 96 hours prior to study entry: dysuria, frequency, urgency, or lower abdominal pain. The participant has nitrite or pyuria (greater than [>]15 white blood cell [WBC]/high-power field [HPF] or the presence of 3 plus (+) /large leukocyte esterase) from a pretreatment clean-catch midstream urine sample based on local laboratory procedures. The participant is capable of giving signed informed consent/assent. Exclusion Criteria: The participant resides in a nursing home or dependent care type facility. The participant has a body mass index >=40.0 kilogram per meter square (kg/m^2) or a body mass index >=35.0 kg/m^2 and is experiencing obesity-related health conditions such as uncontrolled high blood pressure or uncontrolled diabetes. The participant is immunocompromised or has altered immune defenses that may predispose the participant to a higher risk of treatment failure and/or complications. The participant has any of the following: Poorly controlled asthma or chronic obstructive pulmonary disease; Acute severe pain; Active peptic ulcer disease; Parkinson disease; Myasthenia gravis; a history of seizure disorder requiring medications for control (this does not include a history of childhood febrile seizures); Or Known acute porphyria. Any surgical or medical condition (active or chronic) that may interfere with drug absorption, distribution, metabolism, or excretion of the study intervention. The participant has a known glucose-6-phosphate dehydrogenase deficiency. The participant, in the judgment of the investigator, would not be able or willing to comply with the protocol or complete study follow-up. The participant has acute uncomplicated cystitis that is known or suspected to be due to fungal, parasitic, or viral pathogens; or known or suspected to be due to Pseudomonas aeruginosa or Enterobacterales (other than E. coli) as the contributing pathogen. The participant has symptoms known or suspected to be caused by another disease process, such as asymptomatic bacteriuria, overactive bladder, chronic incontinence, or chronic interstitial cystitis, that may interfere with the clinical efficacy assessments or preclude complete resolution of acute cystitis symptoms. The participant has an anatomical or physiological anomaly that predisposes the participant to UTIs or may be a source of persistent bacterial colonization, including calculi, obstruction or stricture of the urinary tract, primary renal disease (e.g., polycystic renal disease), or neurogenic bladder, or the participant has a history of anatomical or functional abnormalities of the urinary tract (e.g., chronic vesicoureteral reflux, detrusor insufficiency). The participant has an indwelling catheter, nephrostomy, ureter stent, or other foreign material in the urinary tract. The participant who, in the opinion of the investigator, has an otherwise complicated UTI, an active upper UTI (e.g., pyelonephritis, urosepsis), signs and symptom onset >=96 hours before study entry, or a temperature >=38 Degrees Celsius [°C], flank pain, chills, or any other manifestations suggestive of upper UTI. The participant has known anuria, oliguria, or significant impairment of renal function (creatinine clearance <60 milliliters per minute (mL/min) or clinically significant elevated serum creatinine as determined by the investigator). The participant presents with vaginal discharge at Baseline (e.g., suspected sexually transmitted disease). The participant has congenital long QT syndrome or known prolongation of the corrected QT (QTc) interval. The participant has uncompensated heart failure. The participant has severe left ventricular hypertrophy. The participant has a family history of QT prolongation or sudden death. The participant has a recent history of vasovagal syncope or episodes of symptomatic bradycardia or brady arrhythmia within the last 12 months. The participant is taking QT-prolonging drugs or drugs known to increase the risk of torsades de pointes (TdP) per the www.crediblemeds.org. "Known Risk of TdP" category at the time of her Baseline Visit, which cannot be safely discontinued from the Baseline Visit to the TOC Visit; or the participant is taking a strong cytochrome P450 enzyme 3A4 (CYP3A4) inhibitor. For any participant >=12 to <18 years of age, the participant has an abnormal ECG reading at Baseline. The participant has a QTc >450 msec or a QTc >480 msec for participants with bundle branch block. The participant has a documented or recent history of uncorrected hypokalemia within the past 3 months. The participant has a known alanine aminotransferase (ALT) value >2 times upper limit of normal (ULN). The participant has a known total bilirubin value >1.5 times ULN (isolated bilirubin >1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin <35 percent [%]). The participant has cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice. The participant has a previous history of cholestatic jaundice/hepatic dysfunction associated with nitrofurantoin. The participant has received treatment with other systemic antimicrobials or systemic antifungals within 1 week before study entry.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name or Official Title & Degree
EU GSK Clinical Trials Call Center
Phone
+44 (0) 20 89904466
Email
GSKClinicalSupportHD@gsk.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Ibaraki
ZIP/Postal Code
300-0062
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Masaru Mori
Facility Name
GSK Investigational Site
City
Osaka
ZIP/Postal Code
534-0024
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Kenji Sugimoto
Facility Name
GSK Investigational Site
City
Saitama
ZIP/Postal Code
352-0001
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Hiroyuki Kusuyama

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
IPD Sharing Time Frame
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
IPD Sharing Access Criteria
Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
IPD Sharing URL
https://www.gsk.com/en-gb/innovation/trials/data-transparency/

Learn more about this trial

A Study to Investigate the Efficacy and Safety With Gepotidacin in Japanese Female Participants With Uncomplicated Urinary Tract Infection (Acute Cystitis)

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