GonorrheaPhase 2NCT02294682
A Dose-Ranging Study Evaluating the Efficacy, Safety, and Tolerability of GSK2140944 in the Treatment of Uncomplicated Urogenital Gonorrhea Caused by Neisseria Gonorrhoeae
A Phase 2 study testing GSK2140944 in people with Gonorrhea, run by GlaxoSmithKline at 14 sites in 3 countries.
Trial summary
GSK2140944 has demonstrated in vitro activity against Neisseria (N.) gonorrhoeae, including ciprofloxacin resistant and susceptible strains. This study is a Phase II, randomized, multicenter, open-label, dose ranging study designed to inform the optimal oral dose of GSK2140944 by further characterizing the efficacy… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gonorrhea
- What is being tested?
- GSK2140944
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 14 sitesin 3 countries
- Study dates
- 15 Apr 2015to 27 Jul 2016
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject is an adult male or female at least 18 years of age at the time of signing informed consent who meets one of the following criteria:
- A non-pregnant, non-lactating female of childbearing potential who 1) is sexually inactive by abstinence, 2) has a sole male partner who has been sterilized, or 3) uses a contraceptive method with a failure rate of <1% through the Test-of-Cure Visit. Females of childbearing potential must not become pregnant during the study.
- A female of non-childbearing potential, which includes the following: Females who are surgically sterile with a documented hysterectomy and/or bilateral oophorectomy; Females with documented tubal ligation. If the procedure was done hysteroscopically, the effectiveness of tubal occlusion must have been documented by hysterosalpingogram after the procedure (typically 3 months after the procedure); Females who are post-menopausal, defined as amenorrhoeic for greater than 1 year. For women whose menopausal status is in doubt, documented previous confirmatory blood samples with follicle-stimulating hormone >40 milli international units (mIU)/millilitre (mL) and estradiol <40 picograms (pg)/mL (<140 picomoles [pmol]/litre [L]) will need to be confirmed, or they will be required to use one of the acceptable contraception methods. Note: For the purposes of these criteria, "documented" includes information obtained via a verbal interview with the subject or from the subject's medical records.
- There is clinical suspicion that the subject has a urogenital gonococcal infection (e.g., prior culture, nucleic acid amplification test [NAAT] or Gram stain presumptive or positive for the presence of N. gonorrhoeae, or sexual contact with a partner diagnosed with gonorrhea within the past 14 days, as reported by the subject). Note: All subjects will be tested for N. gonorrhoeae, but these results will not be used to determine subject eligibility for enrollment in the study.
- The subject has provided written, dated, informed consent and is willing and able to comply with the study protocol.
Who cannot join
- The subject is pregnant or nursing.
- The subject is a hysterectomized female without a cervix.
- The subject is a male with a current diagnosis of epididymitis or orchitis at the time of the Baseline Visit.
- The subject has a body mass index >=40.0 kilograms (kg)/square meter (m^2).
- The subject has a serious underlying disease that could be imminently life threatening, or the subject is unlikely to survive for the duration of the study period.
- The subject has a medical condition or requires medication that may be aggravated by inhibition of acetylcholinesterase, such as: Poorly controlled asthma or chronic obstructive pulmonary disease at baseline and, in the opinion of the investigator, is not stable on current therapy; Acute severe pain, uncontrolled with conventional medical management; Active peptic ulcer disease; Parkinson's disease; Myasthenia gravis; A history of seizure disorder requiring medications for control. This does not include a history of childhood febrile seizures; Any evidence of mechanical obstruction of the urinary or digestive tracks.
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- The subject has had any past history or current diagnosis of Clostridium difficile infection at the time of the Baseline Visit.
- The subject, in the judgment of the investigator, would not be able or willing to comply with the protocol or complete study follow-up.
- The subject has a history of sensitivity to the study medication, or components thereof, or a history of a drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates their participation.
- The subject has a PR interval <120 or >220 milliseconds (msec). Note: Subjects without an evaluable PR interval (e.g., stable atrial fibrillation) are not eligible for this study.
- The subject has a corrected QT (QTc) >450 msec or a QTc >480 msec for subjects with bundle branch block. Note: The QTc is the QT interval corrected for heart rate according to either Bazett formula (QTcB), Fridericia formula (QTcF), machine, or manual overread.
- The subject has QRS duration <70 or >120 msec.
- The subject has pre-existing Grade II atrioventricular block or higher or a history of significant vasovagal and/or syncopal episodes or episodes of symptomatic bradycardia.
- The subject has a current or chronic history of liver disease (with the exception of Gilbert's syndrome), including symptomatic viral hepatitis and moderate to severe liver insufficiency (Child Pugh class B or C).
- The subject has been previously enrolled in this study or has previously been treated with GSK2140944.
- The subject has participated in a clinical trial and has received an investigational product within 30 days or 5 half-lives, whichever is longer.
- The subject has the following gonococcal infections: Suspected or confirmed pelvic inflammatory disease; Suspected or confirmed gonococcal arthritis; Other evidence of disseminated gonococcal infection.
- The subject has received treatment with a systemic or intravaginal antibacterial within 14 days of study entry.
- Subject is taking a medication that has a known risk of torsades de pointes.
Trial locations and contacts
14 sites in 3 countries.
14 sites in 3 countries
United States12 sites
GSK Investigational Site
Atlanta, Georgia, 30308
GSK Investigational Site
Cleveland, Ohio, 44109
GSK Investigational Site
Fountain Valley, California, 92708
GSK Investigational Site
Indianapolis, Indiana, 46202
GSK Investigational Site
Jenkintown, Pennsylvania, 19046
GSK Investigational Site
Los Angeles, California, 90028
GSK Investigational Site
Los Angeles, California, 90069
GSK Investigational Site
New Orleans, Louisiana, 70119
GSK Investigational Site
Omaha, Nebraska, 68114
GSK Investigational Site
Orlando, Florida, 32806
GSK Investigational Site
Palm Springs, California, 92262
GSK Investigational Site
San Francisco, California, 94103
About this study
Official title: A Phase II, Randomized, Multicenter, Dose-Ranging Study in Adult Subjects Evaluating the Efficacy, Safety, and Tolerability of Single Doses of GSK2140944 in the Treatment of Uncomplicated Urogenital Gonorrhea Caused by Neisseria Gonorrhoeae
GSK2140944 has demonstrated in vitro activity against Neisseria (N.) gonorrhoeae, including ciprofloxacin resistant and susceptible strains. This study is a Phase II, randomized, multicenter, open-label, dose ranging study designed to inform the optimal oral dose of GSK2140944 by further characterizing the efficacy, safety, and tolerability in subjects with uncomplicated urogenital gonorrhea due to N. gonorrhoeae. Subjects will be randomly assigned to receive either a single 1500 milligrams (mg) or 3000 mg oral dose of GSK2140944. Appropriate safety and microbiological assessments will be conducted at the Baseline (Day 1) Visit and repeated at the Test-of-Cure (Day 4 to 8) Visit. The study duration will be approximately 1 week. Approximately 60 microbiologically evaluable subjects (30 subjects in each treatment arm) will complete the study if both arms remain active throughout the study.
- Conditions
- Gonorrhea
- Being tested
- GSK2140944
- Keywords
- uncomplicated urogenital gonorrhea, Bacterial Type II Topoisomerase Inhibitors (BTI), antibiotics, GSK2140944, N. gonorrhoeae
- Medical subject headings
- Gonorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK2140944Drug
Immediate release capsules (pink hard gelatin size 00 capsule, with no external marking, filled with slightly agglomerated pale yellowish to grayish yellow powder) containing GSK2140944 500 mg and inactive formulation excipients. GSK2140944 will be administered orally once 1500 mg (3 capsules) or 3000 mg (6 capsules).
| Study group | Role | What they receive |
|---|---|---|
| GSK2140944 1500 mg | Experimental | Subjects will receive single oral dose of GSK2140944 1500 mg. Receives: Drug: GSK2140944 |
| GSK2140944 3000 mg | Experimental | Subjects will receive single oral dose of GSK2140944 3000 mg. Receives: Drug: GSK2140944 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Culture-confirmed Bacterial Eradication of Urogenital Neisseria Gonorrhoeae at the Test-of-Cure Visit
Pre-treatment urogenital, pharyngeal, and rectal swab specimens were obtained for bacteriological culture for neisseria (N.) gonorrhoeae at the Baseline visit. Test- of-Cure was defined by infection site (that is urogenital and, as appropriate, rectal and/or pharyngeal) as culture confirmed bacterial eradication of N. gonorrhoeae observed 3 to 7 days post-treatment. Pre-treatment urogenital specimens were obtained for nucleic acid amplification test (NAAT) assay to detect the presence of N. gonorrhoeae and chlamydia trachomatis at the Baseline visit. Only participants who had a pre-therapy N. gonorrhoeae isolate recovered from their urogenital specimen were evaluated. Microbiologically evaluable (ME) Population comprised of all randomized participants who had N. gonorrhoeae isolated from Baseline cultures of urogenital swab specimens, received any dose of gepotidacin, and returned for their TOC visit.
Measured: Baseline (Day 1, pre-dose) and Test-of-Cure visit (Day 4 to 8)
Secondary outcomes (17)
Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)
An AE is any untoward medical occurrence in a clinical investigation participants, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinaemia (defined as alanine aminotransferase [ALT] >=3 times upper limit of normal [ULN] and bilirubin >=2 times ULN [>35 percent direct] [or ALT >=3 times ULN and international normalization ratio INR>1.5, if INR is measured].
Measured: From start of the study treatment until Test-of-Cure visit (Day 4 to 8)
Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at the Indicated Time Points
BP was measured in semi-supine position after 5 minutes rest. It was recorded at Baseline visit, 2 hour post-dose visit for participants enrolled under orignal protocol, 0.5 hour post-dose for participants enrolled under protocol amendement 1 and up to TOC visit (Day 4 to 8).Vital sign measurements were obtained prior to any scheduled blood collection visit on the same assessment day. Baseline was defined as the study assessment on Day 1 (pre-dose). Change from Baseline was calculated as TOC visit value minus value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Measured: Baseline visit (Day 1) and Day 4 to Day 8
Change From Baseline in Pulse Rate at the Indicated Time Points
Pulse rate was measured in semi-supine position after 5 minutes rest. It was recorded at Baseline visit, 2 hour post-dose visit for participants enrolled under orignal protocol, 0.5 hour post-dose for participants enrolled under protocol amendement 1 and up to TOC visit (Day 4 to 8). Vital sign measurements were obtained prior to any scheduled blood collection visit on the same assessment day. Baseline was defined as the study assessment on Day 1 (pre-dose). Change from Baseline was calculated as TOC visit value minus value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Measured: Baseline visit (Day 1) and Day 4 to Day 8
Change From Baseline in Temperature at the Indicated Time Points
Temperature was measured in semi-supine position after 5 minutes rest. It was recorded at Baseline visit, 2 hour post-dose visit for participants enrolled under orignal protocol, 0.5 hour post-dose for participants enrolled under protocol amendement 1 and up to TOC visit (Day 4 to 8). Vital sign measurements were obtained prior to any scheduled blood collection visit on the same assessment day. Baseline was defined as the study assessment on Day 1 (pre-dose). Change from Baseline was calculated as TOC visit value minus value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Measured: Baseline visit (Day 1) and Day 4 to Day 8
Change From Baseline in Respiratory Rate at the Indicated Time Points
Respiratory rate was measured in semi-supine position after 5 minutes rest. It was recorded at Baseline visit, 2 hour post-dose visit for participants enrolled under orignal protocol, 0.5 hour post-dose for participants enrolled under protocol amendement 1 and up to TOC visit (Day 4 to 8). Vital sign measurements was obtained prior to any scheduled blood collection visit on the same assessment day. Baseline was defined as the study assessment on Day 1 (pre-dose). Change from Baseline was calculated as TOC Visit value minus value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Measured: Baseline visit (Day 1) and Day 4 to Day 8
Number of Participants With Abnormal Electrocardiogram (ECG) Findings
A single 12-lead ECGs were obtained at the Baseline, 2 hour post-dose, and at the TOC (Day 4 to 8) visit using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and corrected QT (QTc) intervals. ECG was obtained prior to any vital sign measurements or blood draws scheduled on the same assessment day. For participants enrolled under protocol amendment 1, ECG was measured at Baseline visit Day 1 (pre-dose) only. ECG assessments were presented as abnormal-clinically significant (CS) and abnormal-not clinically significant (NCS) at the indicated time points. Only those participants available at the specified time points were analyzed (represented by n=X , X in the category titles).
Measured: Baseline visit and up to Day 8
Number of Participants With Abnormal Physical Examination Finding
Physical examination of respiratory, cardiovascular, abdomen, gastrointestinal, urogenital systems, pharyngeal and rectal examinations with collections of microbiology specimen was performed at the Baseline and TOC (Day 4 to 8) visit. Baseline was defined as the study assessment on Day 1 (pre-dose). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Measured: Baseline visit and Test-of-Cure visit (Day 4 to 8)
Change From Baseline in Hemoglobin, Protein and Albumin at Test-of-Cure Visit (Day 4 to 8)
Blood samples were collected at Baseline Day 1 (pre-dose) and at TOC visit (Day 4 to 8) to evaluate hemoglobin, total protein and albumin. Baseline was defined as the study assessment on Day 1 (pre-dose). Change from Baseline was calculated as value obtained at TOC visit minus value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Measured: Baseline visit and Test-of-Cure visit (Day 4 to 8)
Change From Baseline in Hematocrit at Test-of-Cure Visit (Day 4 to 8)
Blood samples were collected at Baseline Day 1 (pre-dose) and at TOC visit (Day 4 to 8) to evaluate hematocrit. Baseline was defined as the study assessment on Day 1 (pre-dose). Change from Baseline was calculated as value obtained at TOC visit minus value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Measured: Baseline visit and Test-of-Cure visit (Day 4 to 8)
Change From Baseline in Lymphocyte, Monocyte, Neutrophil Basophil, Eosinophil, Leukocyte and Platelet Count at Test-of-Cure Visit (Day 4 to 8)
Blood samples were collected at Baseline Day 1 (pre-dose) and at TOC visit (Day 4 to 8) to evaluate neutrophil, lymphocyte, basophil, eosinophil, monocyte, leukocyte and platelet count. Baseline was defined as the study assessment on Day 1 (pre-dose). Change from Baseline was calculated as value obtained at TOC visit minus value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Measured: Baseline visit and Test-of-Cure visit (Day 4 to 8)
Change From Baseline in Bilirubin, Direct Bilirubin and Creatinine at Test-of-Cure Visit (Day 4 to 8)
Blood samples were collected at Baseline Day 1 (pre-dose) and at TOC visit (Day 4 to 8) to evaluate bilirubin, direct bilirubin and creatinine. Baseline was defined as the study assessment on Day 1 (pre-dose). Change from Baseline was calculated as value obtained at TOC visit minus value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Measured: Baseline visit and Test-of-Cure visit (Day 4 to 8)
Change From Baseline in Alanine Aminotransferase, Aspartate Aminotransferase and Alkaline Phosphatase at Test-of-Cure Visit (Day 4 to 8)
Blood samples were collected at Baseline Day 1.(pre-dose) and at TOC visit (Day 4 to 8) to evaluate alanine aminotransferase, aspartate aminotransferase and alkaline phosphatase. Baseline was defined as the study assessment on Day 1 (pre-dose). Change from Baseline was calculated as value obtained at TOC visit minus value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Measured: Baseline visit and Test-of-Cure visit (Day 4 to 8)
Change From Baseline in Chloride, Calcium, Glucose, Potassium, Sodium and Urea at Test-of-Cure Visit (Day 4 to 8)
Blood samples were collected at Baseline Day 1.(pre-dose) and at TOC visit (Day 4 to 8) to evaluate chloride, calcium, glucose, potassium, sodium and urea (blood urea nitrogen). Baseline was defined as the study assessment on Day 1 (pre-dose). Change from Baseline was calculated as value obtained at TOC visit minus value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Measured: Baseline visit and Test-of-Cure visit (Day 4 to 8)
Change From Baseline in Erythrocytes at Test-of-Cure Visit (Day 4 to 8)
Blood samples were collected at Baseline Day 1 (pre-dose) and at TOC visit (Day 4 to 8) to evaluate erythrocytes (red blood cell count). Baseline was defined as the study assessment on Day 1 (pre-dose). Change from Baseline was calculated as value obtained at TOC visit minus value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Measured: Baseline visit and Test-of-Cure visit (Day 4 to 8)
Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin at Test-of-Cure Visit (Day 4 to 8)
Blood samples were collected at Baseline Day 1 (pre-dose) and at TOC visit (Day 4 to 8) to evaluate erythrocytes mean corpuscular hemoglobin. Baseline was defined as the study assessment on Day 1 (pre-dose). Change from Baseline was calculated as value obtained at TOC Visit minus value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Measured: Baseline visit and Test-of-Cure visit (Day 4 to 8)
Change From Baseline in Erythrocytes Mean Corpuscular Volume at Test-of-Cure Visit (Day 4 to 8)
Blood samples were collected at Baseline Day 1 (pre-dose) and at TOC visit (Day 4 to 8) to evaluate erythrocytes mean corpuscular volume. Baseline was defined as the study assessment on Day 1 (pre-dose). Change from Baseline was calculated as value obtained at TOC Visit minus value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Measured: Baseline visit and Test-of-Cure visit (Day 4 to 8)
Number of Participants With Abnormal Urinalysis Dipstick Results
Dipstick urinalysis was done for glucose, ketones, occult blood, protein, potential hydrogen (pH) and specific gravity at Baseline visit Day 1 (pre-dose) and Test-of-Cure visit (Day 4 to 8). Results were presented as negative (normal) or other findings reported only if observed under microscopic examination trace, 1+, 2+, 3+, 4+ and 5+ glucose, ketones, occult blood and protein. pH results were categorized as per their pH values. Baseline was defined as the study assessment on Day 1 (pre-dose). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Measured: Baseline visit and Test-of-Cure visit (Day 4 to 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2014 (estimated)
- Study start15 Apr 2015
- Primary completion1 Jul 2016
- Study completion27 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for GonorrheaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02294682
- Sponsor's protocol ID
- 116576
- Status last verified
- Feb 2017
- First submitted
- 17 Nov 2014
- Last updated
- 23 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Scangarella-Oman NE, Hossain M, Perry CR, Tiffany C, Powell M, Swift B, Dumont EF. Dose selection for a phase III study evaluating gepotidacin (GSK2140944) in the treatment of uncomplicated urogenital gonorrhoea. Sex Transm Infect. 2023 Feb;99(1):64-69. doi: 10.1136/sextrans-2022-055518. Epub 2022 Nov 21.
PubMed 36411033Scangarella-Oman NE, Hossain M, Dixon PB, Ingraham K, Min S, Tiffany CA, Perry CR, Raychaudhuri A, Dumont EF, Huang J, Hook EW 3rd, Miller LA. Microbiological Analysis from a Phase 2 Randomized Study in Adults Evaluating Single Oral Doses of Gepotidacin in the Treatment of Uncomplicated Urogenital Gonorrhea Caused by Neisseria gonorrhoeae. Antimicrob Agents Chemother. 2018 Nov 26;62(12):e01221-18. doi: 10.1128/AAC.01221-18. Print 2018 Dec.
PubMed 30249694Taylor SN, Morris DH, Avery AK, Workowski KA, Batteiger BE, Tiffany CA, Perry CR, Raychaudhuri A, Scangarella-Oman NE, Hossain M, Dumont EF. Gepotidacin for the Treatment of Uncomplicated Urogenital Gonorrhea: A Phase 2, Randomized, Dose-Ranging, Single-Oral Dose Evaluation. Clin Infect Dis. 2018 Aug 1;67(4):504-512. doi: 10.1093/cid/ciy145.
PubMed 29617982
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Multicenter, Dose-Ranging Study in Adult Subjects Evaluating the Efficacy, Safety, and Tolerability of Single Doses of GSK2140944 in the Treatment of Uncomplicated Urogenital Gonorrhea Caused by Neisseria Gonorrhoeae
- ClinicalTrials.gov ID
- NCT02294682
- Acronym / sponsor ID
- 116576
- Conditions
- Gonorrhea
- Keywords
- uncomplicated urogenital gonorrhea, Bacterial Type II Topoisomerase Inhibitors (BTI), antibiotics, GSK2140944, N. gonorrhoeae
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 15 Apr 2015
- Primary completion
- 1 Jul 2016 (actual)
- Study completion
- 27 Jul 2016 (actual)
- First posted
- 19 Nov 2014 (estimated)
- Results
- Posted 23 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
GSK2140944 has demonstrated in vitro activity against Neisseria (N.) gonorrhoeae, including ciprofloxacin resistant and susceptible strains. This study is a Phase II, randomized, multicenter, open-label, dose ranging study designed to inform the optimal oral dose of GSK2140944 by further characterizing the efficacy, safety, and tolerability in subjects with uncomplicated urogenital gonorrhea due to N. gonorrhoeae. Subjects will be randomly assigned to receive either a single 1500 milligrams (mg) or 3000 mg oral dose of GSK2140944. Appropriate safety and microbiological assessments will be conducted at the Baseline (Day 1) Visit and repeated at the Test-of-Cure (Day 4 to 8) Visit. The study duration will be approximately 1 week. Approximately 60 microbiologically evaluable subjects (30 subjects in each treatment arm) will complete the study if both arms remain active throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GSK2140944 1500 mg | Experimental | Drug: GSK2140944Subjects will receive single oral dose of GSK2140944 1500 mg. |
| GSK2140944 3000 mg | Experimental | Drug: GSK2140944Subjects will receive single oral dose of GSK2140944 3000 mg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The subject is an adult male or female at least 18 years of age at the time of signing informed consent who meets one of the following criteria:
- There is clinical suspicion that the subject has a urogenital gonococcal infection (e.g., prior culture, nucleic acid amplification test [NAAT] or Gram stain presumptive or positive for the presence of N. gonorrhoeae, or sexual contact with a partner diagnosed with gonorrhea within the past 14 days, as reported by the subject). Note: All subjects will be tested for N. gonorrhoeae, but these results will not be used to determine subject eligibility for enrollment in the study.
- The subject has provided written, dated, informed consent and is willing and able to comply with the study protocol.
Key exclusion criteria (19 listed)
- The subject is pregnant or nursing.
- The subject is a hysterectomized female without a cervix.
- The subject is a male with a current diagnosis of epididymitis or orchitis at the time of the Baseline Visit.
- The subject has a body mass index >=40.0 kilograms (kg)/square meter (m^2).
- The subject has a serious underlying disease that could be imminently life threatening, or the subject is unlikely to survive for the duration of the study period.
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 |
|---|---|---|
| GSK2140944Immediate release capsules (pink hard gelatin size 00 capsule, with no external marking, filled with slightly agglomerated pale yellowish to grayish yellow powder) containing GSK2140944 500 mg and inactive formulation excipients. GSK2140944 will be administered orally once 1500 mg (3 capsules) or 3000 mg (6 capsules). | Drug | GSK2140944 1500 mg, GSK2140944 3000 mg |
Primary outcome
Number of Participants With Culture-confirmed Bacterial Eradication of Urogenital Neisseria Gonorrhoeae at the Test-of-Cure Visit
Time frame: Baseline (Day 1, pre-dose) and Test-of-Cure visit (Day 4 to 8)
Pre-treatment urogenital, pharyngeal, and rectal swab specimens were obtained for bacteriological culture for neisseria (N.) gonorrhoeae at the Baseline visit. Test- of-Cure was defined by infection site (that is urogenital and, as appropriate, rectal and/or pharyngeal) as culture confirmed bacterial eradication of N. gonorrhoeae observed 3 to 7 days post-treatment. Pre-treatment urogenital specimens were obtained for nucleic acid amplification test (NAAT) assay to detect the presence of N. gonorrhoeae and chlamydia trachomatis at the Baseline visit. Only participants who had a pre-therapy N. gonorrhoeae isolate recovered from their urogenital specimen were evaluated. Microbiologically evaluable (ME) Population comprised of all randomized participants who had N. gonorrhoeae isolated from Baseline cultures of urogenital swab specimens, received any dose of gepotidacin, and returned for their TOC visit.
17 secondary outcomes
Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)
Time frame: From start of the study treatment until Test-of-Cure visit (Day 4 to 8)
Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at the Indicated Time Points
Time frame: Baseline visit (Day 1) and Day 4 to Day 8
Change From Baseline in Pulse Rate at the Indicated Time Points
Time frame: Baseline visit (Day 1) and Day 4 to Day 8
Change From Baseline in Temperature at the Indicated Time Points
Time frame: Baseline visit (Day 1) and Day 4 to Day 8
Change From Baseline in Respiratory Rate at the Indicated Time Points
Time frame: Baseline visit (Day 1) and Day 4 to Day 8
Number of Participants With Abnormal Electrocardiogram (ECG) Findings
Time frame: Baseline visit and up to Day 8
Number of Participants With Abnormal Physical Examination Finding
Time frame: Baseline visit and Test-of-Cure visit (Day 4 to 8)
Change From Baseline in Hemoglobin, Protein and Albumin at Test-of-Cure Visit (Day 4 to 8)
Time frame: Baseline visit and Test-of-Cure visit (Day 4 to 8)
Change From Baseline in Hematocrit at Test-of-Cure Visit (Day 4 to 8)
Time frame: Baseline visit and Test-of-Cure visit (Day 4 to 8)
Change From Baseline in Lymphocyte, Monocyte, Neutrophil Basophil, Eosinophil, Leukocyte and Platelet Count at Test-of-Cure Visit (Day 4 to 8)
Time frame: Baseline visit and Test-of-Cure visit (Day 4 to 8)
Change From Baseline in Bilirubin, Direct Bilirubin and Creatinine at Test-of-Cure Visit (Day 4 to 8)
Time frame: Baseline visit and Test-of-Cure visit (Day 4 to 8)
Change From Baseline in Alanine Aminotransferase, Aspartate Aminotransferase and Alkaline Phosphatase at Test-of-Cure Visit (Day 4 to 8)
Time frame: Baseline visit and Test-of-Cure visit (Day 4 to 8)
Change From Baseline in Chloride, Calcium, Glucose, Potassium, Sodium and Urea at Test-of-Cure Visit (Day 4 to 8)
Time frame: Baseline visit and Test-of-Cure visit (Day 4 to 8)
Change From Baseline in Erythrocytes at Test-of-Cure Visit (Day 4 to 8)
Time frame: Baseline visit and Test-of-Cure visit (Day 4 to 8)
Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin at Test-of-Cure Visit (Day 4 to 8)
Time frame: Baseline visit and Test-of-Cure visit (Day 4 to 8)
Change From Baseline in Erythrocytes Mean Corpuscular Volume at Test-of-Cure Visit (Day 4 to 8)
Time frame: Baseline visit and Test-of-Cure visit (Day 4 to 8)
Number of Participants With Abnormal Urinalysis Dipstick Results
Time frame: Baseline visit and Test-of-Cure visit (Day 4 to 8)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36411033Scangarella-Oman NE, Hossain M, Perry CR, Tiffany C, Powell M, Swift B, Dumont EF. Dose selection for a phase III study evaluating gepotidacin (GSK2140944) in the treatment of uncomplicated urogenital gonorrhoea. Sex Transm Infect. 2023 Feb;99(1):64-69. doi: 10.1136/sextrans-2022-055518. Epub 2022 Nov 21.
- Derived from this study: PubMed 30249694Scangarella-Oman NE, Hossain M, Dixon PB, Ingraham K, Min S, Tiffany CA, Perry CR, Raychaudhuri A, Dumont EF, Huang J, Hook EW 3rd, Miller LA. Microbiological Analysis from a Phase 2 Randomized Study in Adults Evaluating Single Oral Doses of Gepotidacin in the Treatment of Uncomplicated Urogenital Gonorrhea Caused by Neisseria gonorrhoeae. Antimicrob Agents Chemother. 2018 Nov 26;62(12):e01221-18. doi: 10.1128/AAC.01221-18. Print 2018 Dec.
- Derived from this study: PubMed 29617982Taylor SN, Morris DH, Avery AK, Workowski KA, Batteiger BE, Tiffany CA, Perry CR, Raychaudhuri A, Scangarella-Oman NE, Hossain M, Dumont EF. Gepotidacin for the Treatment of Uncomplicated Urogenital Gonorrhea: A Phase 2, Randomized, Dose-Ranging, Single-Oral Dose Evaluation. Clin Infect Dis. 2018 Aug 1;67(4):504-512. doi: 10.1093/cid/ciy145.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
14 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GSK2140944 in people with Gonorrhea, run by GlaxoSmithKline at 14 sites in 3 countries.
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 5 inclusion and 19 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 23 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, Puerto Rico, United Kingdom. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 23 May 2017). 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 Culture-confirmed Bacterial Eradication of Urogenital Neisseria Gonorrhoeae at the Test-of-Cure Visit (time frame: Baseline (Day 1, pre-dose) and Test-of-Cure visit (Day 4 to 8)). 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 NCT02294682, which also lists 3 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 23 May 2017.