| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Chemotherapy induced peripheral neuropathy |
| neuropatia periferica indotta da chemioterapia |
|
| E.1.1.1 | Medical condition in easily understood language |
| Damages to nerves of the peripheral nervous system, induced by chemotherapy |
| danni ai nervi del sistema nervoso periferico, indotto da chemioterapia |
|
| E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 20.1 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10079545 |
| E.1.2 | Term | Chemotherapy induced peripheral neuropathy |
| E.1.2 | System Organ Class | 100000004852 |
|
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
| To compare PledOx (5 ¿mol/kg) vs placebo with respect to the proportion of patients with moderate or severe chronic CIPN |
| Confrontare PledOx (5 ¿mol/kg) con il placebo, tenuto conto della proporzione di pazienti affetti da CIPN cronica moderata o grave. |
|
| E.2.2 | Secondary objectives of the trial |
To compare PledOx vs placebo:
To compare the effects of levoketoconazole with placebo on:
1 cortisol status during Randomized Withdrawal & Restoration Phases
2 changes in biomarkers of CS comorbidities
3 changes in health related quality of life & depression;
4 changes in acne, hirsutism & peripheral edema
5 To assess levoketoconazole safety & tolerability
6 To evaluate the population pharmacokinetics of levoketoconazole in CS
subjects
NOTE:Secondary Objectives 5 & 6 are not subjects of hypothesis tests
Exploratory Objectives:
1 To assess changes in anti-diabetic, anti-cholesterol, anti-hypertensive
& chronic anti-inflammatory therapies
2 To describe effects & durations of levoketoconazole with respect to
cortisol status & clinical signs & symptoms of CS other than acne,
hirsutism & peripheral edema
Per gli obiettivi esplorativi fare riferimento alla sinossi per superamento dei caratteri disponibili |
Confrontare gli effetti del levoketoconazolo con il placebo sullo:
1. stato del cortisolo durante la fase di sospensione randomizzata (Randomized Withdrawal, RW) e la successiva fase di ripristino;
2. cambiamenti nei biomarcatori delle comorbilità della CS
3. cambiamenti nella qualità della vita (Quality of Life, QoL) correlata alla salute e sui sintomi della depressione;
4. cambiamenti nell’acne, nell’irsutismo e nell’edema periferico;
5. Valutare la sicurezza e la tollerabilità del levoketoconazolo;
6. Valutare la farmacocinetica (pharmacokinetics, PK) di popolazione del levoketoconazolo in soggetti con CS.
NOTA: Gli obiettivi secondari 5 e 6 non sono soggetti a test delle ipotesi.
Esploratori:
1. Valutare i cambiamenti nelle terapie antidiabetiche, anticolesterolo, antipertensive e antinfiammatorie croniche;
2. Descrivere effetti e durata dell’azione levoketocona
Per gli obiettivi esplorativi fare riferimento alla sinossi per superamento dei caratteri disponibili |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
1. Signed informed consent form before any study related assessments and willing to follow all study procedures.
2. Male or female aged =18 years.
3. Pathologically confirmed adenocarcinoma of the colon or rectum including: Stage III carcinoma (any T N1,2 M0) or Stage II carcinoma (T3,4 N0 M0).
4. The patient has undergone curative (R0) surgical resection performed within 12 weeks prior to randomization.
5. The patient has a postsurgical CEA level =1.5 x upper limit of normal (ULN, in current smokers, CEA level =2.0 x ULN is allowed).
6. No prior anti-cancer therapy for CRC except radiotherapy or concomitant chemoradiotherapy using a fluoropyrimidine alone for locoregional rectal cancer.
7. Patient indicated for up to 6 months of oxaliplatin-based chemotherapy and without pathological findings of a neurologic exam performed prior to oxaliplatin treatment according to local practice
8. ECOG performance status of 0 or 1.
9. Adequate hematological parameters: hemoglobin =100 g/L, absolute neutrophil count (ANC) =1.5 x 109 /L, platelets =100 x 109 /L.
10. Adequate renal function: creatinine clearance >50 cc/min using the Cockcroft and Gault formula or measured.
11. Adequate hepatic function: total bilirubin =1.5 x ULN (except in the case of known Gilbert’s syndrome); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =3 x ULN (AST and ALT =5 x ULN in case of liver metastases).
12. Baseline blood Mn level <2.0 x ULN
13. For patients with a history of diabetes mellitus, HbA1c =7%.
14. Negative pregnancy test for females of child-bearing potential.
15. For men and females of childbearing potential, use of adequate contraception (oral contraceptives, intrauterine device or barrier method of contraception in conjunction with spermicidal jelly or surgically sterile) while on study drug and for at least 6 months after completion of study therapy. |
1. Firma del modulo per il consenso informato prima di eseguire qualsiasi valutazione correlata allo studio e intenzione di seguire tutte le procedure di studio.
2. Uomo o donna di età uguale o superiore ai 18 anni.
3. Adenocarcinoma del colon o del retto patologicamente confermato compresi: carcinoma di stadio III (qualsiasi T N1/N2 M0) o carcinoma di stadio II (T3/T4 N0 M0).
4. Il paziente è stato sottoposto a resezione chirurgica curativa (R0) effettuata nelle 12 settimane prima della randomizzazione.
5. Il paziente presenta un livello di antigene carcinoembrionale post-chirurgico (CEA) =1,5 volte il limite superiore del normale (ULN, nei fumatori attivi, livello CEA =2,0 x ULN è permesso).
6. Assenza di precedente terapia antitumorale contro il CRC ad eccezione di radioterapia o concomitante chemio-radioterapia usando una fluoropirimidina in monoterapia per cancro del retto locoregionale.
7. Paziente con prescrizione di chemioterapia a base di oxaliplatino di almeno 3 mesi (senza interruzioni terapeutiche pianificate) e privo di risultati patologici di un esame neurologico eseguito prima del trattamento con oxaliplatino secondo la pratica locale
8. Performance status di 0 o 1
9. Parametri ematologici adeguati: emoglobina =100 g/l, conta assoluta dei neutrofili (ANC) =1,5 x 109/l, piastrine =100 x 109/l.
10. Funzione renale adeguata: clearance della creatinina >50 cc/min in base alla formula di Cockcroft-Gault o alla misurazione.
11. Funzione epatica adeguata: bilirubina totale =1,5 volte il limite superiore della norma (ULN) (eccetto in caso di sindrome di Gilbert acclarata); aspartato aminotrasferasi (AST) e alanina aminotrasferasi (ALT) =3 volte l’ULN (AST e ALT =5 volte l’ULN in caso di metastasi epatiche).
12. Livello di manganese (Mn) ematico al basale <2,0 volte l’ULN.
13. Per i pazienti con anamnesi di diabete mellito, HbA1c =7%.
14. Per le donne potenzialmente fertili, test di gravidanza negativo.
15. Per le donne potenzialmente fertili e gli uomini, utilizzo di un adeguato metodo anticoncezionale (contraccettivi orali, dispositivo intrauterino o metodo contraccettivo a barriera in combinazione con gel spermicida o sterilizzazione chirurgica) durante l’assunzione del farmaco in studio e durante almeno i 6 mesi successivi al completamento della terapia di studio. |
|
| E.4 | Principal exclusion criteria |
1. Any evidence of metastatic disease.
2. Any unresolved toxicity by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v.4.03) >Grade 1 from previous anti-cancer therapy (including radiotherapy), except alopecia.
3. Any grade of neuropathy from any cause.
4. Any evidence of severe or uncontrolled systemic diseases (e.g., unstable or uncompensated respiratory, cardiac, unresolved bowel obstruction, hepatic or renal disease).
5. Chronic infection or uncontrolled serious illness causing immunodeficiency. Patients with known history of chronic hepatitis B can be enrolled if they are asymptomatic and an acute and active HBV
infection can be excluded.
6. Any history of seizure
7. Recent (<28 days) surgery prior to entry into the study or a surgical incision that is not fully healed.
8. Known hypersensitivity to any of the components of mFOLFOX6 and, if applicable, therapies to be used in conjunction with the chemotherapy regimen or any of the excipients of these products.
9. History of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within 5 years, unless the patient has been disease free for that other malignancy for at least 2 years.
10. Known dihydropyrimidine dehydrogenase deficiency.
11. Pre-existing neurodegenerative disease (e.g., Parkinson’s, Alzheimer’s, Huntington’s) or neuromuscular disorder (e.g., multiple sclerosis, amyotrophic lateral sclerosis, polio, hereditary neuromuscular disease).
12. Major psychiatric disorder (major depression, psychosis), alcohol and/or drug abuse.
13. Patients with a history of second or third degree atrioventricular block or a family heredity.
14. A history of a genetic or familial neuropathy.
15. Treatment with any investigational drug within 30 days prior to randomization.
16. Pregnancy, lactation or reluctance to using contraception.
17. Any other condition that, in the opinion of the Investigator, places the patient at undue risk.
18. Previous exposure to mangafodipir or calmangafodipir.
19. Welders, mine workers or other workers in occupations (current or past) where high Mn exposure is likely.
Please refer to the synospis/protocl |
1. Qualsiasi evidenza di malattia metastatica.
2. Eventuali tossicità non risolte, come definite dai criteri CTCAE v4.03 (Common Terminology Criteria for Adverse Events) superiori al grado 1, scaturite da precedenti terapie anticancro (compresa radioterapia), eccetto l’alopecia.
3. Qualsiasi grado di neuropatia provocato da qualsiasi causa.
4. Qualsiasi evidenza di patologia sistemica grave o non controllata (per es., patologie respiratorie, cardiache, epatiche o renali instabili o non compensate, occlusione intestinale non risolta).
5. Infezione cronica o patologie gravi non controllate che provochino immunodeficienza. I pazienti con anamnesi nota di epatite B cronica sono arruolabili purché risultino asintomatici e sia possibile escludere un’infezione da HBV acuta e attiva.
6. Anamnesi di crisi convulsive
7. Intervento chirurgico recente (<28 giorni) prima dell’entrata nello studio o incisione chirurgica non completamente cicatrizzata.
8. Ipersensibilità nota a uno qualsiasi dei componenti di mFOLFOX6 e, ove applicabile, delle terapie da utilizzare in concomitanza con il regime chemioterapico o ipersensibilità a uno degli eccipienti dei suddetti prodotti.
9. Anamnesi di altre neoplasie maligne (eccetto in caso di carcinoma a cellule basali o squamose o di carcinoma in situ adeguatamente trattati) durante gli ultimi cinque anni, a meno che il paziente non sia libero dalla suddetta malattia da almeno 2 anni.
10. Carenza acclarata di diidropirimidina deidrogenasi.
11. Patologie neurodegenerative preesistenti (per es., morbo di Parkinson, morbo di Alzheimer, morbo di Huntington) o malattie neuromuscolari (per es., sclerosi multipla, sclerosi laterale amiotrofica, poliomielite o malattia neuromuscolare ereditaria).
12. Disturbi psichiatrici maggiori (depressione maggiore, psicosi), abuso di alcol e/o di droghe.
13. Pazienti con anamnesi di blocco atrio-ventricolare di secondo o terzo grado o con ereditarietà familiare.
14. Anamnesi di neuropatia genetica o familiare.
15. Trattamento con farmaci sperimentali durante i 30 giorni precedenti la randomizzazione.
16. Gravidanza, allattamento o riluttanza all’utilizzo della contraccezione.
17. Qualsiasi altra condizione che, secondo il parere dello sperimentatore ,esponga il paziente a un rischio eccessivo.
18. Precedente esposizione al mangafodipir o al calmangafodipir.
19. Saldatori, minatori o lavoratori occupati (attualmente o in passato) in campi che comportino una probabile esposizione a elevate quantità di manganese.
Fare riferimento alla sinossi/protocollo per superamento dei caratteri disponibili. |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
Proportion of patients scoring 3 or 4, derived as the maximum score of
items NTX 1 to 4, in any of the symptoms of numbness, tingling and
discomfort in hands and feet in the FACT/GOG-NTX-13, 9 months after the first dose. |
| Proporzione di pazienti con punteggio 3 o 4 in almeno uno dei primi 4 item della scala FACT/GOG-NTX-13 (cioè FACT/GOG-NTX-4) relativi a intorpidimento, formicolio o fastidio a mani e/o piedi, 9 mesi dopo la prima dose di IMP |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
| 9 months after first dose of IMP |
| 9 mesi dopo la prima dose di IMP |
|
| E.5.2 | Secondary end point(s) |
1. Changes from Baseline (RW0) in mUFC and LNSC at all post-Baseline
visits with these assessments through the final study visit (RES2)—
applies to Secondary Objective 1;
2. Proportion of subjects with normalization of mUFC at RES2—applies to
Secondary Objective 1;
3. Changes from Baseline (RW0) in biomarkers of CS comorbidities
(fasting glucose, fasting insulin, homeostatic model assessment-insulin
resistance [HOMA-IR], hemoglobin A1c (HbA1c), total cholesterol, low
density lipoprotein-cholesterol (LDL-C), and high-sensitivity C-reactive
protein (hsCRP) at all post-Baseline visits with these measurements
through the final study visit (RES2)—applies to Secondary Objective 2;
4. Changes from Baseline (RW0) in health-related QoL and symptoms of
depression at all post-Baseline visits with these assessments through
the final study visit (RES2)—applies to Secondary Objective 3;
5. Changes from Baseline (RW0) in acne, hirsutism and peripheral
edema at all post-Baseline visits with these assessments through the
final study visit (RES2)—applies to Secondary Objective 4;
6. Incidence and severity of adverse events (AEs), particularly adverse
events of special interest (AESI) during
levoketoconazole open-label therapy in the TM Phase (levoketoconazole
naïve cohort) and during blinded therapy in the Randomized Withdrawal
and Restoration Phases (both cohorts)—applies to Secondary Objective
5.
Pharmacokinetic Endpoints and Pharmacokinetic/Pharmacodynamic
modeling:
7. Estimates of the following PK parameters: clearance (CL/F), volume of
distribution (V/F), absorption rate constant (Ka), with associated
between subject variability where feasible. These parameters will be
used to calculate half-life (t½), area under the concentration time curve
(AUC) and peak concentration (Cmax), if feasible—applies to Secondary
Objective 6;
8. Estimates of the following pharmacodynamic (PD) parameters:
levoketoconazole concentration producing half maximal UFC suppression
(IC50), maximal suppression of UFC (Imax) and associated estimates of
between-subject variability, if feasible. UFC concentrations in relation to
dose and plasma exposure will be explored—applies to Secondary
Objective 6.
Exploratory Endpoints:
9. Frequency of usage and changes from Baseline (RW0) in frequency of
usage of anti-diabetic, anti-cholesterol, anti-hypertensive, and chronic
anti-inflammatory therapies at all post-Baseline visits; changes in
corresponding biomarkers accounting for changes in medication usage
will also be explored—applies to Exploratory Objective 1;
10. Time from RW0 to first time of loss of response
(1) mUFC is above 1.5X the ULN of the central laboratory's reference
range, OR
(2) mUFC is more than 40% above the RW0 value, if the RW0 value is
above the
ULN (i.e. >1.0X ULN)2, OR
(3) an early rescue criterion is met—applies to Exploratory Objective 2;—
applies to Exploratory Objective 2;
11. Time to first normalization of mUFC beginning from RW5 (subset
with mUFC above 1.5X ULN at RW5)—applies to Exploratory Objective 2;
12. Time to first normalization of LNSC beginning from RW5 (subset with
LNSC above ULN at RW5)—applies to Exploratory Objective 2;
13. Proportion of subjects with normalization of LNSC at RES2—applies
to Exploratory Objective 2;
14. Changes from Baseline (RW0) in serum cortisol and
adrenocorticotrophic hormone (ACTH) at all post-Baseline visits with
these assessments through the final study visit (RES2)—applies to
Exploratory Objective 2;
15. Changes from Baseline (RW0) in clinical signs and symptoms of CS
excluding acne, hirsutism and peripheral edema at all post-Baseline
visits with these assessments through the final study visit (RES2)—
applies to Exploratory Objective 2;
16. Frequency and severity of common AEs and laboratory abnormalities
in relation to dose of study drug administered at the time of the reported
AE or laboratory abnormality—applies to Exploratory Objective 3;
due to a limit of characters please refer to protocol; Efficacy
¿ Proportion of patients (with mild, moderate or severe chronic CIPN) scoring 2, 3, or 4, in at least 1 of the first 4 items of the FACT/GOG-NTX-
13 (i.e. FACT/GOG-NTX-4), targeting numbness, tingling or discomfort in hands and/or feet, 9 months after the first dose of IMP
¿ Mean change from baseline in sensitivity to touching cold items on Day2, Cycle 4 of mFOLFOX6 chemotherapy, as assessed by the Cold
Sensitivity questionnaire
¿ Mean cumulative dose of oxaliplatin administered per patient during mFOLFOX6 chemotherapy, 9 months after the first dose of IMP
¿ Mean change from baseline in vibration sense, on the lateral malleolus (left and right), using a graduated tuning fork, at 9 months after the first
dose of IMP
¿ Mean change from baseline in worst pain in hands or feet in the past week, using a numerical rating scale (NRS), at 9 months after the first
dose of IMP
¿ Mean change from baseline in the time to complete the grooved Pegboard with the non-dominant hand, at 9 months after the f |
1. Changes from Baseline (RW0) in mUFC and LNSC at all post-Baseline
visits with these assessments through the final study visit (RES2)—
applies to Secondary Objective 1;
2. Proportion of subjects with normalization of mUFC at RES2—applies to
Secondary Objective 1;
3. Changes from Baseline (RW0) in biomarkers of CS comorbidities
(fasting glucose, fasting insulin, homeostatic model assessment-insulin
resistance [HOMA-IR], hemoglobin A1c (HbA1c), total cholesterol, low
density lipoprotein-cholesterol (LDL-C), and high-sensitivity C-reactive
protein (hsCRP) at all post-Baseline visits with these measurements
through the final study visit (RES2)—applies to Secondary Objective 2;
4. Changes from Baseline (RW0) in health-related QoL and symptoms of
depression at all post-Baseline visits with these assessments through
the final study visit (RES2)—applies to Secondary Objective 3;
5. Changes from Baseline (RW0) in acne, hirsutism and peripheral
edema at all post-Baseline visits with these assessments through the
final study visit (RES2)—applies to Secondary Objective 4;
6. Incidence and severity of adverse events (AEs), particularly adverse
events of special interest (AESI) during
levoketoconazole open-label therapy in the TM Phase (levoketoconazole
naïve cohort) and during blinded therapy in the Randomized Withdrawal
and Restoration Phases (both cohorts)—applies to Secondary Objective
5.
Pharmacokinetic Endpoints and Pharmacokinetic/Pharmacodynamic
modeling:
7. Estimates of the following PK parameters: clearance (CL/F), volume of
distribution (V/F), absorption rate constant (Ka), with associated
between subject variability where feasible. These parameters will be
used to calculate half-life (t½), area under the concentration time curve
(AUC) and peak concentration (Cmax), if feasible—applies to Secondary
Objective 6;
8. Estimates of the following pharmacodynamic (PD) parameters:
levoketoconazole concentration producing half maximal UFC suppression
(IC50), maximal suppression of UFC (Imax) and associated estimates of
between-subject variability, if feasible. UFC concentrations in relation to
dose and plasma exposure will be explored—applies to Secondary
Objective 6.
Exploratory Endpoints:
9. Frequency of usage and changes from Baseline (RW0) in frequency of
usage of anti-diabetic, anti-cholesterol, anti-hypertensive, and chronic
anti-inflammatory therapies at all post-Baseline visits; changes in
corresponding biomarkers accounting for changes in medication usage
will also be explored—applies to Exploratory Objective 1;
10. Time from RW0 to first time of loss of response
(1) mUFC is above 1.5X the ULN of the central laboratory's reference
range, OR
(2) mUFC is more than 40% above the RW0 value, if the RW0 value is
above the
ULN (i.e. >1.0X ULN)2, OR
(3) an early rescue criterion is met—applies to Exploratory Objective 2;—
applies to Exploratory Objective 2;
11. Time to first normalization of mUFC beginning from RW5 (subset
with mUFC above 1.5X ULN at RW5)—applies to Exploratory Objective 2;
12. Time to first normalization of LNSC beginning from RW5 (subset with
LNSC above ULN at RW5)—applies to Exploratory Objective 2;
13. Proportion of subjects with normalization of LNSC at RES2—applies
to Exploratory Objective 2;
14. Changes from Baseline (RW0) in serum cortisol and
adrenocorticotrophic hormone (ACTH) at all post-Baseline visits with
these assessments through the final study visit (RES2)—applies to
Exploratory Objective 2;
15. Changes from Baseline (RW0) in clinical signs and symptoms of CS
excluding acne, hirsutism and peripheral edema at all post-Baseline
visits with these assessments through the final study visit (RES2)—
applies to Exploratory Objective 2;
16. Frequency and severity of common AEs and laboratory abnormalities
in relation to dose of study drug administered at the time of the reported
AE or laboratory abnormality—applies to Exploratory Objective 3;
due to a limit of characters please refer to protocol; Efficacia
¿ Proporzione di pazienti (affetti da CIPN cronica leggera, moderata o grave) con punteggio 2, 3 o 4 in almeno uno dei primi 4 item della scala FACT/GOG-NTX-13 (cio¿ FACT/GOG-NTX-4) relativi a intorpidimento, formicolio o fastidio a mani e/o piedi, 9 mesi dopo la prima dose di IMP.
¿ Variazione media della sensibilit¿ al contatto con gli oggetti freddi rispetto al basale il Giorno 2 del Ciclo 4 di chemioterapia con mFOLFOX6, misurata in base al questionario Sensibilit¿ al Freddo.
¿ Dose cumulativa media di oxaliplatino somministrata per paziente durante la chemioterapia con mFOLFOX6, 9 mesi dopo la prima dose di IMP.
¿ Variazione media rispetto al basale della sensibilit¿ alle vibrazioni rilevata al malleolo laterale (destro e sinistro) mediante diapason graduato, 9 mesi dopo la prima dose di IMP.
¿ Variazione media rispetto al basale del dolore pi¿ intenso a mani o piedi durante la settimana precedente, misurata mediante scala di valutazione numerica (NRS), 9 mesi dopo la prima dose di I |
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
- FACT/GOG-NTX-13, Grooved pegboard, Grad. Tuning fork, Pain NRS:
treatment visits 1-12 (D1 of each Cyc), assessment visits M3, 6, 9, 12, 18
& 24, EoT (D14 last cycle)
- AEs: treatment V1-12, EoT
- DFS : assessment M3, 6, 9, 12, 18 & 24, EoS
- Biochem & Blood Mn: Screen, treatment V1, 4, 8, 12, EoT
- Hemato: Screen, treatment V1-12, EoT
- Vital sign, ECOG: Screen, treatment V1-12, M3, 6, 9, 12, 18 & 24, EoT
- Cold sensitivity: Screen, treatment V2, 4 & 8
- QoL/health status: treatment V1, 4, 8 & 12, M6-24
- Physical exam: Screen, assesment M3-24, EoT
- MRI of CNS and Blood Mn incl. neuro exam: treatment visits 1-12, M3,
EoT
- ECG: Screen
- Health eco: treament V1, EoT, M12 & M24; - FACT/GOG-NTX-13, Grooved pegboard, Grad. Tuning fork, Pain NRS:
treatment visits 1-12 (D1 of each Cyc), asses |
| -; - |
|
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | Yes |
| E.6.3 | Therapy | Yes |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | No |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | No |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | Yes |
| E.6.13 | Others | No |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | No |
| E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | No |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | Yes |
| E.8.1.5 | Parallel group | Yes |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | No |
| E.8.2.2 | Placebo | Yes |
| E.8.2.3 | Other | No |
| E.8.2.4 | Number of treatment arms in the trial | 2 |
| E.8.3 |
The trial involves single site in the Member State concerned
| No |
| E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
| E.8.4.1 | Number of sites anticipated in Member State concerned | 10 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 80 |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
| E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
| E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
| Hong Kong |
| Japan |
| Korea, Republic of |
| Taiwan |
| Belgium |
| Czechia |
| France |
| Germany |
| Italy |
| Spain |
| United Kingdom |
|
| E.8.7 | Trial has a data monitoring committee | Yes |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 3 |
| E.8.9.1 | In the Member State concerned months | 4 |
| E.8.9.1 | In the Member State concerned days | 0 |
| E.8.9.2 | In all countries concerned by the trial years | 3 |
| E.8.9.2 | In all countries concerned by the trial months | 4 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
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