AzTrials
AzTrials

Urinary Tract InfectionsPhase 3EAGLE-JNCT05630833

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

A Phase 3 study testing Gepotidacin and Nitrofurantoin in people with Urinary Tract Infections, run by GlaxoSmithKline at 27 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the consistency of therapeutic response of gepotidacin 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]… Read more about this study

Who is it for?
Ages 12 years and older, women only
Conditions the study is for
Urinary Tract Infections
What is being tested?
Gepotidacin and Nitrofurantoin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
380 participants
Where
27 sitesJapan
Study dates
11 Jan 2023to 2 Feb 2024
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 12 years and older
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 30Show fewer
  • 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.

Trial locations and contacts

27 sites in 1 country.

27 sites in 1 country

Japan27 sites

  • GSK Investigational Site

    Chiba, 263-0043

  • GSK Investigational Site

    Chiba, 270-0034

  • GSK Investigational Site

    Chiba, 272-0107

  • GSK Investigational Site

    Chiba, 286-0201

  • GSK Investigational Site

    Fukuoka, 810-0001

  • GSK Investigational Site

    Fukuoka, 811-0120

  • GSK Investigational Site

    Fukuoka, 814-0013

  • GSK Investigational Site

    Fukuoka, 816-0943

  • GSK Investigational Site

    Gunma, 370-0826

  • GSK Investigational Site

    Hokkaido, 006-0816

  • GSK Investigational Site

    Ibaraki, 300-0062

  • GSK Investigational Site

    Ibaraki, 305-0821

  • GSK Investigational Site

    Kagoshima, 890-0073

  • GSK Investigational Site

    Kanagawa, 231-0861

  • GSK Investigational Site

    Kanagawa, 232-0067

  • GSK Investigational Site

    Kochi, 781-0085

  • GSK Investigational Site

    Miyagi, 980-0803

  • GSK Investigational Site

    Osaka, 534-0024

  • GSK Investigational Site

    Osaka, 564-0063

  • GSK Investigational Site

    Saga, 840-0831

  • GSK Investigational Site

    Saitama, 352-0001

  • GSK Investigational Site

    Saitama, 360-0012

  • GSK Investigational Site

    Tokyo, 130-0026

  • GSK Investigational Site

    Tokyo, 162-0804

  • GSK Investigational Site

    Tokyo, 167-0051

  • GSK Investigational Site

    Tokyo, 175-0093

  • GSK Investigational Site

    Tokyo, 186-0002

Other trials in Japan

About this study

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)

The purpose of this study is to evaluate the consistency of therapeutic response of gepotidacin 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]).

Being tested
Gepotidacin, Nitrofurantoin, Placebo
Keywords
Acute cystitis, Efficacy, Gepotidacin, Nitrofurantoin, Urinary Tract Infection, Japanese Female
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.

  • GepotidacinDrug

    Gepotidacin will be administered.

  • NitrofurantoinDrug

    Nitrofurantoin will be administered.

  • PlaceboDrug

    Placebo will be administered.

Study groups in NCT05630833
Study groupRoleWhat they receive
Gepotidacin + PlaceboExperimentalNot described
Receives: Drug: Gepotidacin; Drug: Placebo
Nitrofurantoin + PlaceboActive comparatorNot described
Receives: Drug: Nitrofurantoin; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Therapeutic Response (TR) (Combined Per-participant Microbiological and Clinical Success) for Gepotidacin at the Test of Cure (TOC) Visit

    TR at TOC (success/failure) is a measure of the overall efficacy response. A therapeutic success at TOC referred to participant who have been deemed both a microbiological success (reduction of all qualifying bacterial uropathogens recovered at BL to <10^3 colony forming units per milliliter [CFU/mL] without receiving other systemic antimicrobials [AB] before the TOC visit) and a clinical success (resolution of symptoms of acute cystitis present at BL and no new symptoms without receiving other AB before the TOC visit [or AB for uUTI on day of TOC visit]). Lack of clinical or microbiological success (including missing outcome assessments) was considered as therapeutic failure.

    Measured: At TOC visit (Days 9 to 16)

Secondary outcomes (34)

  1. Number of Participants With Therapeutic Response (TR) of Gepotidacin Compared to Nitrofurantoin at the Test of Cure (TOC) Visit - Micro-ITT NTF-S Population

    TR at TOC (success/failure) is a measure of the overall efficacy response. A therapeutic success at TOC referred to participant who have been deemed both a microbiological success (reduction of all qualifying bacterial uropathogens recovered at BL to <10^3 colony forming units per milliliter [CFU/mL] without receiving other systemic antimicrobials [AB] before the TOC visit) and a clinical success (resolution of symptoms of acute cystitis present at BL and no new symptoms without receiving other AB before the TOC visit [or AB for uUTI on day of TOC visit]). Lack of clinical or microbiological success (including missing outcome assessments) was considered as therapeutic failure.

    Measured: At TOC visit (Days 9 to 16)

  2. Number of Participants With Clinical Outcome at the TOC Visit - Micro-ITT NTF-S Population

    Clinical outcome at TOC was categorized as clinical resolution, clinical improvement, clinical worsening and unable to determine. Clinical resolution at TOC was defined as resolution of signs and symptoms of acute cystitis present at BL (and no symptoms) without receiving any other AB before the TOC visit. Clinical improvement at TOC was defined as improvement (but not complete resolution) in total symptom score (CSS) from BL, without receiving any other AB before the TOC visit. Clinical worsening at TOC was defined as worsening or no change in CSS from BL or received other AB for the current infection (uUTI) before or on the date of the TOC visit. Unable to determine outcome criteria were: BL score is missing (and thus improvement/worsening cannot be determined), TOC assessment is missing, or receipt of other AB not for the current infection before the TOC visit (unless clinical worsening outcome criteria were met).

    Measured: At TOC visit (Days 9 to 16)

  3. Number of Participants With Clinical Response at the TOC Visit - Micro-ITT NTF-S Population

    Clinical response at TOC was categorized as clinical success and clinical failure. Clinical success at TOC was defined as resolution of symptoms of acute cystitis present at BL (and no new symptoms), without receiving any other AB before the TOC visit. Lack of resolution, including receipt of an AB for uUTI at the TOC visit, or a missing outcome assessment was defined as Clinical Failure at TOC.

    Measured: At TOC visit (Days 9 to 16)

  4. Number of Participants With Microbiological Outcome (MO) at the TOC Visit -Micro-ITT NTF-S Population

    Participant-level MO at TOC was categorized as microbiological eradication (ME), microbiological persistence (MP), microbiological recurrence (MR) and unable to determine (UTD). ME at TOC was defined as all baseline qualifying uropathogens (QUP) have an outcome of eradication at TOC (i.e., <10^3 CFU/mL without the participant receiving other systemic antimicrobials before the TOC Visit). MP at TOC was defined as at least 1 QUP has an outcome of persistence (≥10^3 CFU/mL) at TOC. MR at TOC was defined as at least 1 QUP had an outcome of recurrence and none have an outcome of persistence at TOC. UTD at TOC was defined as all QUP outcomes are UTD at TOC.

    Measured: At TOC visit (Days 9 to 16)

  5. Number of Participants With Microbiological Response at the TOC Visit -Micro-ITT NTF-S Population

    Participant-level microbiological response at TOC was categorized as microbiological success and microbiological failure. Microbiological success at TOC was defined as all baseline qualifying uropathogens (QUP) had a microbiological outcome of eradication at TOC visit. Microbiological failure was defined as lack of microbiological success, including those participants with UTD outcomes.

    Measured: At TOC visit (Days 9 to 16)

  6. Number of Participants With Therapeutic Response (TR) at the TOC Visit

    TR at TOC (success/failure) is a measure of the overall efficacy response. A therapeutic success at TOC referred to participant who have been deemed both a microbiological success (reduction of all qualifying bacterial uropathogens recovered at BL to <10^3 colony forming units per milliliter [CFU/mL] without receiving other systemic antimicrobials [AB] before the TOC visit) and a clinical success (resolution of symptoms of acute cystitis present at BL and no new symptoms without receiving other AB before the TOC visit [or AB for uUTI on day of TOC visit]). Lack of clinical or microbiological success (including missing outcome assessments) was considered as therapeutic failure.

    Measured: At TOC visit (Days 9 to 16)

  7. Number of Participants With Clinical Outcome at the TOC Visit

    Clinical outcome at TOC was categorized as clinical resolution, clinical improvement, clinical worsening and unable to determine. Clinical resolution at TOC was defined as resolution of signs and symptoms of acute cystitis present at BL (and no symptoms) without receiving any other AB before the TOC visit. Clinical improvement at TOC was defined as improvement (but not complete resolution) in CSS from BL, without receiving any other AB before the TOC visit. Clinical worsening at TOC was defined as worsening or no change in CSS from BL or received other AB for the current infection (uUTI) before or on the date of the TOC visit. Unable to determine outcome criteria were: BL score is missing (and thus improvement/worsening cannot be determined), TOC assessment is missing, or receipt of other AB not for the current infection before the TOC visit (unless clinical worsening outcome criteria were met).

    Measured: At TOC visit (Days 9 to 16)

  8. Number of Participants With Clinical Response at the TOC Visit

    Clinical response at TOC was categorized as clinical success and clinical failure. Clinical success at TOC was defined as resolution of symptoms of acute cystitis present at BL (and no new symptoms), without receiving any other AB before the TOC visit. Lack of resolution, including receipt of an AB for uUTI at the TOC visit, or a missing outcome assessment was defined as Clinical Failure at TOC.

    Measured: At TOC visit (Days 9 to 16)

  9. Number of Participants With Microbiological Outcome at the TOC Visit

    Participant-level MO at TOC was categorized as microbiological eradication (ME), microbiological persistence (MP), microbiological recurrence (MR) and unable to determine (UTD). ME at TOC was defined as all baseline qualifying uropathogens (QUP) have an outcome of eradication at TOC (i.e., <10^3 CFU/mL without the participant receiving other systemic antimicrobials before the TOC Visit). MP at TOC was defined as at least 1 QUP has an outcome of persistence (≥10^3 CFU/mL) at TOC. MR at TOC was defined as at least 1 QUP had an outcome of recurrence and none have an outcome of persistence at TOC. UTD at TOC was defined as all QUP outcomes are UTD at TOC.

    Measured: At TOC visit (Days 9 to 16)

  10. Number of Participants With Microbiological Response at the TOC Visit

    Participant-level microbiological response at TOC was categorized as microbiological success and microbiological failure. Microbiological success at TOC was defined as all baseline qualifying uropathogens (QUP) had a microbiological outcome of eradication at TOC visit. Microbiological failure was defined as lack of microbiological success, including those participants with UTD outcomes.

    Measured: At TOC visit (Days 9 to 16)

  11. Number of Participants With Investigator Assessed Clinical Response

    Clinical response as assessed by investigator at TOC was categorized as clinical success and clinical failure. Clinical success at TOC was defined as sufficient resolution of acute cystitis signs and symptoms such that no additional systemic AB was required for the current infection. No apparent response to treatment, use of additional systemic AB for the current infection and death related to acute cystitis prior to the visit was considered as Clinical failure. Indeterminate/Missing was defined as participant lost to follow-up and/or the clinical assessment was not undertaken, use of confounding systemic AB for another infection, and death prior to the visit where acute cystitis was clearly noncontributory.

    Measured: At TOC visit (Days 9 to 16)

  12. Number of Participants With Treatment-emergent Adverse Events (TEAEs)

    An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. TEAE is defined as any AE with an onset date on or after treatment start date/time. AEs were coded using Medical Dictionary for Regulatory Activities (MedDRA).

    Measured: From first dose (Day 1) to Follow-up visit (Days 21 to 31)

  13. Number of Participants With Serious AEs (SAEs) and Adverse Events of Special Interest (AESIs)

    An SAE is defined as any untoward medical occurrence that, at any dose may result in death or is life-threatening or requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity or is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment or is associated with liver injury and impaired liver function. Adverse events of special interest (AESI) for gepotidacin included clostridium difficile, cardiovascular \& gastrointestinal events and potential acetylcholinesterase-inhibition AESIs. SAEs were coded using MedDRA.

    Measured: From first dose (Day 1) to Follow-up visit (Days 21 to 31)

  14. Number of Participants With Urinalysis Dipstick Results

    Urine samples were collected for urinalysis: Urine Glucose (GLU), Urine Ketones (KET), Urine Nitrite (NIT) and Urine Protein (PRO). Baseline is defined as the latest pre-dose assessment with a non-missing value. The dipstick test gives results in a semi-quantitative manner, and results can be read as Negative, Positive, 2777.55 micromole per liter (µmol/l), >=27775.5 µmol/l, 8332.65 µmol/l, 5 milligram/dl (mg/dL), 20 mg/dL, >=80 mg/dL, 300 mg/dL, 1000 mg/dL, >=5000 mg/dL indicating concentrations in the urine sample.

    In the row title (GLU, Baseline, 2777.55 micromole per liter), GLU indicates parameter, Baseline is the visit and 2777.55 micromole per liter indicates the concentration/presence in the urine sample. Data is presented in similar way for other parameters.

    Measured: Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16)

  15. Change From Baseline (CFB) in Electrocardiograms (ECGs): Heart Rate

    Triplicate 12-lead ECGs (over an approximate 5 to 10 minute period) were performed using an ECG machine that automatically calculated the heart rate, measured PR, QRS, QT, and QT interval corrected for heart rate according to Fridericia's formula (QTcF). Baseline is defined as the latest pre-dose assessment with a non-missing value.

    Measured: Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16)

  16. Change From Baseline (CFB) in Electrocardiograms (ECGs): PR, QRS, QT and QTcF

    Triplicate 12-lead ECGs (over an approximate 5 to 10 minute period) were performed using an ECG machine that automatically calculated the heart rate, measured PR, QRS, QT, and QTcF. Baseline is defined as the latest pre-dose assessment with a non-missing value.

    Measured: Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16)

  17. Change From Baseline (CFB) in Vital Sign: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)

    SBP and DBP were measured in a semi-supine position after 5 minutes rest. Baseline is defined as the latest pre-dose assessment with a non-missing value.

    Measured: Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16)

  18. Change From Baseline (CFB) in Vital Sign: Temperature

    Temperature was measured in a semi-supine position after 5 minutes rest. Baseline is defined as the latest pre-dose assessment with a non-missing value.

    Measured: Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16)

  19. Change From Baseline (CFB) in Vital Sign: Pulse Rate

    Pulse rate was measured in a semi-supine position after 5 minutes rest. Baseline is defined as the latest pre-dose assessment with a non-missing value.

    Measured: Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16)

  20. Plasma Concentrations of Gepotidacin

    Blood samples were collected for plasma concentration of Gepotidacin.

    Measured: Baseline (Day 1 at 0-2h & >2h Post dose), Day 2 to 5 at Pre-dose, 0-2h & >2h Post Dose

  21. Urine Concentrations of Gepotidacin

    Urine samples were collected for urine concentration of Gepotidacin.

    Measured: Baseline (Day 1 at 0-2h & >2h Post dose), Day 2 to 5 at Pre-dose, 0-2h & >2h Post Dose

  22. Change From Baseline (CFB) in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, and Platelets at On Therapy and Test of Cure Visit

    Blood samples were collected for the analysis of hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils, and platelets. Baseline is defined as the latest pre-dose assessment with a non-missing value.

    Measured: Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16)

  23. Change From Baseline (CFB) in Hematology Parameter-Hemoglobin Level at On Therapy and Test of Cure Visit

    Blood samples were collected for the analysis of hemoglobin level. Baseline is defined as the latest pre-dose assessment with a non-missing value

    Measured: Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16)

  24. Change From Baseline (CFB) in Hematology Parameter- Hematocrit Level at On Therapy and Test of Cure Visit

    Blood samples were collected for the analysis of hematocrit level. Baseline is defined as the latest pre-dose assessment with a non-missing value.

    Measured: Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16)

  25. Change From Baseline (CFB) in Hematology Parameter- Erythrocytes Count at On Therapy and Test of Cure Visit

    Blood samples were collected for the analysis of erythrocytes count. Baseline is defined as the latest pre-dose assessment with a non-missing value.

    Measured: Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16)

  26. Change From Baseline (CFB) in Hematology Parameter - Mean Corpuscular Hemoglobin (MCH) at On Therapy and Test of Cure Visit

    Blood samples were collected for the analysis of MCH. Baseline is defined as the latest pre-dose assessment with a non-missing value.

    Measured: Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16)

  27. Change From Baseline (CFB) in Hematology Parameter - Mean Corpuscular Volume (MCV) at On Therapy and Test of Cure Visit

    Blood samples were collected for the analysis of MCV. Baseline is defined as the latest pre-dose assessment with a non-missing value.

    Measured: Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16)

  28. Change From Baseline (CFB) in Clinical Chemistry Parameters - Calcium, Glucose, Potassium, Magnesium, Phosphate, Sodium, and Urea Nitrogen Levels at On Therapy and Test of Cure Visit

    Blood samples were collected for the analysis of clinical chemistry parameters. Baseline is defined as the latest pre-dose assessment with a non-missing value.

    Measured: Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16)

  29. Change From Baseline (CFB) in Clinical Chemistry Parameters - Serum Chloride at On Therapy and Test of Cure Visit

    Blood samples were collected for the analysis of clinical chemistry parameters. Baseline is defined as the latest pre-dose assessment with a non-missing value

    Measured: Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16)

  30. Change From Baseline (CFB) in Clinical Chemistry Parameters - Direct Bilirubin, Total Bilirubin and Creatinine Levels at On Therapy and Test of Cure Visit

    Blood samples were collected for the analysis of clinical chemistry parameters. Baseline is defined as the latest pre-dose assessment with a non-missing value.

    Measured: Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16)

  31. Change From Baseline (CFB) in Clinical Chemistry Parameters - Creatinine Clearance at On Therapy and Test of Cure Visit

    Blood samples were collected for the analysis of clinical chemistry parameters. Baseline is defined as the latest pre-dose assessment with a non-missing value.

    Measured: Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16)

  32. Change From Baseline (CFB) in Clinical Chemistry Parameters - Albumin and Protein Levels at On Therapy and Test of Cure Visit

    Blood samples were collected for the analysis of clinical chemistry parameters. Baseline is defined as the latest pre-dose assessment with a non-missing value.

    Measured: Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16)

  33. Change From Baseline (CFB) in Clinical Chemistry Parameters - Alkaline Phosphatase (ALP) and Alanine Aminotransferase (ALT) Levels at On Therapy and Test of Cure Visit

    Blood samples were collected for the analysis of clinical chemistry parameters. Baseline is defined as the latest pre-dose assessment with a non-missing value.

    Measured: Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16)

  34. Change From Baseline (CFB) in Clinical Chemistry Parameter - Aspartate Aminotransferase (AST) Levels at On Therapy and Test of Cure Visit

    Blood samples were collected for the analysis of clinical chemistry parameters. Baseline is defined as the latest pre-dose assessment with a non-missing value.

    Measured: Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Nov 2022
  2. Study start11 Jan 2023
  3. Primary completion2 Feb 2024
  4. Study completion2 Feb 2024

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
380 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05630833
Sponsor's protocol ID
214144
Acronym
EAGLE-J
Status last verified
Mar 2025
First submitted
23 Nov 2022
Last updated
17 Mar 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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/

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Gepotidacin and Nitrofurantoin in people with Urinary Tract Infections, run by GlaxoSmithKline at 27 sites in Japan.

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 4 inclusion and 30 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 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in Japan. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Participants With Therapeutic Response (TR) (Combined Per-participant Microbiological and Clinical Success) for Gepotidacin at the Test of Cure (TOC) Visit (time frame: At TOC visit (Days 9 to 16)). 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 NCT05630833.

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 17 Mar 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in