Clinical trial • Phase III • Oncology|Rare Disease

LUTETIUM (177LU) OXODOTREOTIDE for Gastroenteropancreatic neuroendocrine tumor (GEP-NET)

Phase III trial of LUTETIUM (177LU) OXODOTREOTIDE for Gastroenteropancreatic neuroendocrine tumor (GEP-NET).

Overview

Trial Therapeutic Area
Oncology|Rare Disease
Trial Disease
Gastroenteropancreatic neuroendocrine tumor (GEP-NET)
Trial Stage
Phase III
Drug Modality
Radiopharmaceutical|Peptide/protein/enzyme
Paediatric Trial
Yes
Orphan Drug
Yes

Key dates

Initial CTIS Submission Date
31-03-2025
First CTIS Authorization Date
10-07-2025

Trial design

Randomised, open-label, octreotide lar (sandostatin lar) — active comparator; dose and schedule not specified in the available documents-controlled Phase III trial in France, Hungary, Italy and others.

Randomised
Yes
Open Label
Yes
Comparator
Octreotide LAR (Sandostatin LAR) — active comparator; dose and schedule not specified in the available documents
Target Sample Size
141

Eligibility

Recruits 141 paediatric patients.

Vulnerable Population
The trial includes adolescent participants (aged ≥12 years) except in Germany, Hungary, the Netherlands and Poland where only adult participants ≥18 years will be enrolled. Adolescent assent forms and parent/legal guardian consent forms are provided (documents: L1_ICF - Adolescent Assent, L1_ICF - Parent Legal Guardian) and country-specific informed consent/assent documents are available in local languages.

Inclusion criteria

  • {"criterion_text":"- Presence of metastasized or locally advanced, unresectable (curative intent), histologically proven, well differentiated G1 or G2 (Ki-67 <10%) GEP-NET diagnosed within 6 months prior to screening.\n- Participants with high disease burden in the Investigator's opinion. Following criteria should be used as the guiding principle for determining high disease burden: • Primary tumor or a metastatic lesion > 4 cm • More than one tumor or metastatic lesions measuring > 2 cm • Elevated alkaline phosphatase > 2.5 X upper limit of normal (ULN) • Presence of bone metastasis • Presence of peritoneal metastasis • Symptoms due to tumor volume such as pain, fatigue, weight loss, anorexia etc. • Symptoms due to hormone excess requiring active management Additionally, participants who, in the Investigator's opinion, have high disease burden due to their disease characteristics not specified above could also be considered eligible. The clinical characteristics of the disease must be clearly recorded in the electronic case report form.\n- Participants ≥ 12 years of age. For Germany, Hungary, The Netherlands and Poland, only adult participants ≥ 18 years of age will be enrolled.\n- Radioligand imaging (RLI) SSTR uptake on all target lesions (defined by RECIST v1.1 criteria) at least as high as normal liver uptake, assessed within 3 months prior to randomization. Any of the RLI modalities such as, [68Ga]Ga-DOTA-TOC PET/CT or PET/MRI, [68Ga]Ga-DOTA-TATE PET/CT or PET/MRI, [64Cu]Cu-DOTA-TATE PET/CT or PET/MRI, somatostatin receptor scintigraphy (SRS) (planar and/or SPECT/CT) with [111In]In-pentetreotide, or SRS (planar and/or SPECT/CT) with [99mTc]Tc-octreotide, can be used as per local practice.\n- Adequate bone marrow and organ function as defined by the following laboratory values prior to receiving the first study treatment: a. White blood cells (WBCs) ≥ 2 x 109/L* b. Platelet count ≥ 75 x 109/L* c. Hemoglobin ≥ 8 g/dL* d. Creatinine clearance > 40 mL/min calculated by the Cockcroft Gault method e. Total bilirubin ≤ 3 x ULN f. Potassium within normal limits. Potassium level of up to 6.0 millimoles per liter (mmol/L) is acceptable at study entry if associated with creatinine clearance withinr normal limits calculated using Cockcroft-Gault formula. Mild decrease (grade 1) below lower limit of normal (LLN) is acceptable at study entry if considered not clinically significant by Investigator. See details regarding potassium assessment and Lysine – Arginine amino acid solution administration in Section 8.4.4. *No platelet transfusion packed red cell transfusion, or granulocyte-colony stimulating factor (G-CSF) will be allowed during screening after ICF signature. Transfusion for the sole purpose of making a participant eligible for the study inclusion is not allowed.\n- ECOG performance status 0-1.\n- Presence of at least 1 measurable site of disease"}

Exclusion criteria

  • {"criterion_text":"- Prior administration of a therapeutic radiopharmaceutical for GEP-NET at any time prior to randomization in the study.\n- Any previous therapy with interferons, mTOR-inhibitors, chemotherapy or other systemic therapies (except SSAs; please refer to exclusion criteria # 3 for further details) of GEP-NET. If as per Investigator opinion a participant is a candidate for such therapies, such participant must not be enrolled.\n- Participant who received more than 4 cycles of prior SSA (e.g., octreotide LAR) are not eligible. In addition, any participant receiving treatment with short-acting octreotide, which cannot be interrupted for 24 h before the administration of [177Lu]Lu-DOTA-TATE, or any participant receiving treatment with SSAs, which cannot be interrupted for at least 4 weeks before the administration of [177Lu]Lu-DOTA-TATE.\n- Documented RECIST v1.1 progression during previous SSA treatments for the current GEP-NET at any time prior to randomization.\n- Any previous radioembolization, chemoembolization and radiofrequency ablation for GEP-NET\n- Any major surgery within 12 weeks prior to randomization in the study.\n- Known brain metastases.\n- Participant with known intolerance to CT scans with i.v. contrast due to allergic reaction or renal insufficiency. If such a participant can be imaged with MRI, then the participant would not be excluded.\n- Active severe urinary incontinence, severe voiding dysfunction, or urinary obstruction requiring an indwelling/condom catheter that, in the judgment of the Investigator, could prevent adhering to radiation safety instructions.\n- Hypersensitivity to any somatostatin analogues, to the Investigational Medicinal Products (IMPs) active substance or to any of the excipients."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- PFS, defined as the time from randomization to the first occurrence of progression (centrally assessed by Blinded Independent Review Committee (BIRC) according to RECIST v1.1) or death due to any cause","definition_or_measurement_approach":"Defined as the time from randomization to the first occurrence of progression (centrally assessed by Blinded Independent Review Committee (BIRC) according to RECIST v1.1) or death due to any cause"}

Secondary endpoints

  • {"endpoint_text":"- Time to deterioration (by an absolute change of at least 15%), defined as the time from randomization to the first occurrence of deterioration compared to baseline scores or death from any cause for each of the following domains (tested separately) of EORTC QLQ-GI.NET21 [gastrointestinal scale (GI scale)] and EORTC QLQ-C30 questionnaires (fatigue, diarrhea, and global health scale).","definition_or_measurement_approach":"Defined as time from randomization to first deterioration (absolute change ≥15%) compared to baseline scores or death for specified domains of EORTC QLQ-GI.NET21 and EORTC QLQ-C30; domains tested separately (fatigue, diarrhea, global health)."}
  • {"endpoint_text":"- PFS, defined as the time from randomization to the first occurrence of progression (Investigator assessed according to RECIST v1.1) or death due to any cause.","definition_or_measurement_approach":"Time from randomization to first progression as assessed by Investigator per RECIST v1.1 or death from any cause."}
  • {"endpoint_text":"- Objective response rate (ORR): Rate of participants with best overall response (BOR) of partial response (PR) or complete response (CR) as per RECIST v1.1 (both Investigator and centrally assessed by BIRC).","definition_or_measurement_approach":"Proportion of participants with BOR of PR or CR per RECIST v1.1; assessed both by Investigator and centrally by BIRC."}
  • {"endpoint_text":"- Disease control rate (DCR): Rate of participants with BOR of PR, CR or stable disease (SD) as per RECIST v1.1 (both Investigator and centrally assessed by BIRC).","definition_or_measurement_approach":"Proportion of participants with BOR of PR, CR or SD per RECIST v1.1; assessed by Investigator and centrally by BIRC."}
  • {"endpoint_text":"- DOR: The time from initially meeting the criteria for response (CR or PR) until the time of progression according to RECIST v1.1 or death due to underlying disease only.","definition_or_measurement_approach":"Time from first meeting CR/PR criteria until progression per RECIST v1.1 or death due to underlying disease."}
  • {"endpoint_text":"- Incidence and severity of adverse events (AEs) and serious adverse event (SAEs), changes in laboratory values, vital signs and ECGs. Tolerability: Dose interruptions, discontinuations, and reductions.","definition_or_measurement_approach":"Safety assessed by incidence and severity of AEs/SAEs, laboratory changes, vital signs, ECGs; tolerability by dose interruptions, discontinuations, and dose reductions."}
  • {"endpoint_text":"- OS: Time from the randomization date until the date of death due to any cause.","definition_or_measurement_approach":"Time from randomization to death from any cause."}
  • {"endpoint_text":"- • TTD (using the same definition as for key secondary endpoints) for EORTC QLQ-G.I.NET21 and EORTC QLQ-C30 domains not included among key secondary endpoints • Absolute change from baseline in EORTC QLQ-G.I.NET21 and EORTC QLQ-C30 domains. • Absolute change from baseline in the EQ-5D-5L index at each timepoint.","definition_or_measurement_approach":"TTD defined as per key secondary endpoints; absolute changes from baseline in EORTC QLQ-GI.NET21 and QLQ-C30 domains and EQ-5D-5L index measured at specified timepoints."}
  • {"endpoint_text":"- Absorbed radiation dose in selected organs, tumor lesions and total body.","definition_or_measurement_approach":"Measurement of absorbed radiation dose in selected organs, tumor lesions and total body (dosimetry assessments)."}
  • {"endpoint_text":"- PK parameters (Area Under Curve (AUC), clearance, distribution volume, half-life) from [177Lu]Lu-DOTA-TATE blood radioactivity data.","definition_or_measurement_approach":"Pharmacokinetic parameters (AUC, clearance, volume of distribution, half-life) derived from blood radioactivity measurements of [177Lu]Lu-DOTA-TATE."}

Recruitment

Planned Sample Size
141
Recruitment Window Months
114
Consent Approach
Adult participants provide informed consent using country-specific Main ICF documents. For minors/adolescents (participants aged ≥12 years where permitted), an adolescent assent form is provided and a Parent/Legal Guardian consent form is available. Country-specific languages and versions of ICF/assent documents are provided (examples in the record: French, Hungarian, English, Italian, Spanish, Dutch, German, Polish). Note: Germany, Hungary, The Netherlands and Poland restrict enrollment to adults ≥18 years.

Methods

  • Patient recruitment materials provided by Jumo Health USA Inc. (contact: hello@jumohealth.com) as listed among third parties (role: Patient Recruitment materials).
  • Country-specific recruitment arrangements and advertisement documents submitted (K1/K2 recruitment arrangements and advertisements) for each participating country (documents present but content/details not specified in the record).

Geography

Total Number Of Sites
41
Total Number Of Participants
100

France

Earliest CTIS Part Ii Submission Date
13-06-2025
Latest Decision Or Authorization Date
04-12-2025
Processing Time Days
174
Number Of Sites
11
Number Of Participants
17

Sites

Site Name
Hospices Civils De Lyon
Department Name
1404: Medical Oncology
Contact Person Name
Laura GERARD
Contact Person Email
laura.gerard@chu-lyon.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
1401: Endocrinology and Endocrine Oncology
Contact Person Name
Magalie HAISSAGUERRE
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
1401: Endocrinology and Endocrine Oncology
Contact Person Name
Magalie HAISSAGUERRE
Site Name
Hopital Beaujon
Department Name
1400: Pancreatology and Digestive Oncology
Contact Person Name
Louis DE MESTIER
Contact Person Email
louis.demestier@aphp.fr
Site Name
Hospices Civils De Lyon
Department Name
1404: Medical Oncology
Contact Person Name
Laura GERARD
Contact Person Email
laura.gerard@chu-lyon.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
1401: Endocrinology and Endocrine Oncology
Contact Person Name
Magalie HAISSAGUERRE
Site Name
Hospices Civils De Lyon
Department Name
1404: Medical Oncology
Contact Person Name
Laura GERARD
Contact Person Email
laura.gerard@chu-lyon.fr
Site Name
Institut Regional Du Cancer De Montpellier
Department Name
1406: Nuclear Medicine
Contact Person Name
Emmanuel DESHAYES
Site Name
Institut Paoli Calmettes
Department Name
1402: Medical Oncology
Contact Person Name
Sandrine OZIEL-TAIEB
Contact Person Email
oziels@ipc.unicancer.fr
Site Name
Oncopole Claudius Regaud
Department Name
1403: Nuclear medicine and metabolic irradiation
Contact Person Name
Dierickx LAWRENCE
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
1405: Nuclear Medicine
Contact Person Name
Catherine ANSQUER

Hungary

Earliest CTIS Part Ii Submission Date
19-05-2025
Latest Decision Or Authorization Date
08-12-2025
Processing Time Days
203
Number Of Sites
2
Number Of Participants
5

Sites

Site Name
Semmelweis University
Department Name
1600: Belgyogyaszati es Onkologiai Klinika
Contact Person Name
Lakatos Peter
Contact Person Email
lakatos.peter@semmelweis.hu
Site Name
University Of Szeged
Department Name
1601: Nuklearis Medicina Intezet
Contact Person Name
Pavics Laszlo
Contact Person Email
pavics.laszlo@szte.hu

Italy

Earliest CTIS Part Ii Submission Date
18-06-2025
Latest Decision Or Authorization Date
03-12-2025
Processing Time Days
168
Number Of Sites
9
Number Of Participants
17

Sites

Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
#1703:U.O.C. Oncologia Medica DH Oncologia Medica
Contact Person Name
Giovanni SCHINZARI
Site Name
University Hospital Of Ferrara
Department Name
#1706:U.O.C Medicina Nucleare
Contact Person Name
Mirco BARTOLOMEI
Contact Person Email
m.bartolomei@ospfe.it
Site Name
Azienda Ospedaliero Universitaria Pisana
Department Name
#1705:U.O. Oncologia Medica 2
Contact Person Name
Riccardo MARCONCINI
Contact Person Email
marconcini.riccardo@gmail.com
Site Name
Azienda Ospedaliero-Universitaria Sant Andre
Department Name
#1704:U.O.C. Malattie Apparato Digerente e del Fegato
Contact Person Name
Francesco PANZUTO
Contact Person Email
fpanzuto@ospedalesantandrea.it
Site Name
IRCCS Ospedale Sacro Cuore Don Calabria
Department Name
#1708:Servizio di Medicina Nucleare e Terapia Radiometabolica
Contact Person Name
Matteo SALGARELLO
Site Name
IRCCS Ospedale Policlinico San Martino
Department Name
#1702:U.O. di Endocrinologia
Contact Person Name
Manuela ALBERTELLI
Contact Person Email
manuela.albertelli@unige.it
Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
#1701:S.C. Oncologia Medica 1
Contact Person Name
Sara PUSCEDDU
Site Name
Istituto Europeo Di Oncologia S.r.l.
Department Name
#1700:Unità Oncologia Medica Gastrointestinale e Tumori Neuroendocrini
Contact Person Name
Nicola FAZIO
Contact Person Email
nicola.fazio@ieo.it
Site Name
Humanitas Mirasole S.p.A.
Department Name
#1707:U.O. Oncologia Medica ed Ematologia Humanitas Cancer Center
Contact Person Name
Alexia BERTUZZI
Contact Person Email
alexia.bertuzzi@humanitas.it

Poland

Earliest CTIS Part Ii Submission Date
17-06-2025
Latest Decision Or Authorization Date
08-12-2025
Processing Time Days
174
Number Of Sites
7
Number Of Participants
21

Sites

Site Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
Department Name
#1901: Zaklad Medycyny Nuklearnej Endokrynologii, Endokrynologii Onkologicznej, Medycyny Nuklearnej
Contact Person Name
Anna Sowa-Staszczak
Contact Person Email
staszcz@su.krakow.pl
Site Name
Uniwersytecki Szpital Kliniczny W Poznaniu
Department Name
#1904: Oddział Kliniczny Endokrynologii, Przemiany Materii i Chorob Wewnętrznych
Contact Person Name
Marcin Ruchala
Contact Person Email
mruchala@ump.edu.pl
Site Name
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
Department Name
#1903: Klinika Endokrynologii i Terapii Izotopowej, Centrum Wsparcia Badan Klinicznych
Contact Person Name
Grzegorz Kaminski
Contact Person Email
gkaminski@wim.mil.pl
Site Name
Centrum Diagnostyczno-Lecznicze Gammed
Department Name
#1902: Centrum Diagnostyczno-Lecznicze Gammed
Contact Person Name
Agnieszka Kolasinska-Cwikła
Contact Person Email
adkolasinska@yahoo.com
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
#1900: Zaklad Medycyny Nuklearnej i Endokrynologii Onkologicznej
Contact Person Name
Daria Handkiewicz Junak
Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
#1905: Klinika Endokrynologii i Chorob Wewnętrznych, Osrodek Badan Klinicznych Wczesnych Faz
Contact Person Name
Renata Swiatkowska-Stodulska
Contact Person Email
rswiatkowska@uck.gda.pl
Site Name
Centrum Diagnostyczno-Lecznicze Gammed (additional site listed)
Department Name
#1902: Centrum Diagnostyczno-Lecznicze Gammed

Netherlands

Earliest CTIS Part Ii Submission Date
09-07-2025
Latest Decision Or Authorization Date
03-12-2025
Processing Time Days
147
Number Of Sites
2
Number Of Participants
8

Sites

Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name
#1801: Department of Internal Medicine
Contact Person Name
Hans Hofland
Contact Person Email
j.hofland@erasmusmc.nl
Site Name
Universitair Medisch Centrum Utrecht
Department Name
#1800:Department of Radiology and Nuclear Medicine
Contact Person Name
Marnix Lam
Contact Person Email
m.lam@umcutrecht.nl

Spain

Earliest CTIS Part Ii Submission Date
16-06-2025
Latest Decision Or Authorization Date
27-03-2026
Processing Time Days
284
Number Of Sites
7
Number Of Participants
21

Sites

Site Name
Institut Catala D'oncologia
Department Name
#2001:Oncology
Contact Person Name
Ramon Salazar Soler
Contact Person Email
ramonsalazar@iconcologia.net
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
#2006:Oncology
Contact Person Name
Angela Lamarca Lete
Contact Person Email
angela.lamarca@quironsalud.es
Site Name
Hospital Universitario Central De Asturias
Department Name
#2004:Oncology
Contact Person Name
Paula Jimenez Fonseca
Contact Person Email
palucaji@hotmail.com
Site Name
Hospital Universitari Vall D Hebron
Department Name
#2000:Oncology
Contact Person Name
Jorge Hernando Cubero
Contact Person Email
jhernando@vhio.net
Site Name
Hospital Universitario 12 De Octubre
Department Name
#2002:Oncology
Contact Person Name
Rocio Garcia Carbonero
Contact Person Email
rgcarbonero@gmail.com
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
#2005:Oncology
Contact Person Name
Javier Molina Cerrillo
Contact Person Email
javier.molinace@gmail.com
Site Name
Complejo Asistencial Universitario De Salamanca
Department Name
#2003: Oncology
Contact Person Name
Emilio Fonseca Sanchez
Contact Person Email
efonseca@saludcastillayleon.es

Germany

Earliest CTIS Part Ii Submission Date
20-06-2025
Latest Decision Or Authorization Date
24-04-2026
Processing Time Days
308
Number Of Sites
3
Number Of Participants
11

Sites

Site Name
Universitaetsklinikum Essen AöR
Department Name
1500: Klinik für Nuklearmedizin
Contact Person Name
Ken Herrmann
Contact Person Email
ken.herrmann@uk-essen.de
Site Name
Universitaetsklinikum Erlangen AöR
Department Name
1501: Medizinische Klinik I
Contact Person Name
Marianne Pavel
Contact Person Email
marianne.pavel@uk-erlangen.de
Site Name
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
Department Name
1502: Klinik und Poliklinik für Nuklearmedizin
Contact Person Name
Matthias Eiber
Contact Person Email
matthias.eiber@tum.de

Sponsor

Primary sponsor

Full Name
Novartis Pharma AG
Organisation Type
Pharmaceutical company
Country Of Registered Address
Switzerland

Contract research organisations

Name
Parexel International (IRL) Limited
Responsibilities
sponsorDuties codes: ["12"]
Name
IQVIA Limited
Responsibilities
sponsorDuties codes: ["3"]
Name
Eresearchtechnology Inc.
Responsibilities
sponsorDuties codes: ["13"]
Name
Bioclinica Inc.
Responsibilities
sponsorDuties codes: ["13"]

Third parties

  • {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"sponsorDuties codes: [\"12\"]","organisation_type":"Pharmaceutical company"}
  • {"country":"France","full_name":"Kayentis","duties_or_roles":"sponsorDuties codes: [\"7\"]","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Spain","full_name":"Advanced Accelerator Applications Molecular Imaging Iberica S.L.","duties_or_roles":"sponsorDuties codes: [\"14\"]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"sponsorDuties codes: [\"4\"]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Jumo Health USA Inc.","duties_or_roles":"Patient Recruitment materials (sponsorDuties code: \"15\")","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"sponsorDuties codes: [\"13\"]","organisation_type":"Pharmaceutical company"}
  • {"country":"Spain","full_name":"Advanced Accelerator Applications Molecular Imaging Iberica S.L.","duties_or_roles":"sponsorDuties codes: [\"14\"]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"sponsorDuties codes: [\"13\"]","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"sponsorDuties codes: [\"3\"]","organisation_type":"Pharmaceutical company"}
  • {"country":"France","full_name":"Creapharm Clinical Supplies","duties_or_roles":"Drug distribution, storage, relabeling, return and destruction (sponsorDuties codes: [\"14\",\"15\"])","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Lutathera 370 MBq/mL solution for infusion
Active Substance
LUTETIUM (177LU) OXODOTREOTIDE
Modality
Radiopharmaceutical
Routes Of Administration
IV INFUSION
Route
IV INFUSION
Authorisation Status
EU/1/17/1226/001
Orphan Designation
Yes
Maximum Dose
maxDailyDoseAmount 200 mCi; maxTotalDoseAmount 800 mCi
Investigational Product Name
SANDOSTATIN LAR (10 mg / 20 mg / 30 mg powder and solvent for suspension for injection)
Active Substance
OCTREOTIDE
Modality
Peptide/protein/enzyme
Routes Of Administration
INTRAMUSCULAR INJECTION
Route
INTRAMUSCULAR INJECTION
Authorisation Status
MA1249/00603 (10 mg), MA1249/00604 (20 mg), MA1249/00605 (30 mg)
Dose Levels
10 mg; 20 mg; 30 mg (product strengths listed)
Maximum Dose
maxDailyDoseAmount 30 mg (as recorded in product entries)
Combination Treatment
Yes

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