Clinical trial • Phase IV • Gastroenterology
Pancreas powder (pancreatin) for Pancreatic exocrine insufficiency
Phase IV trial of Pancreas powder (pancreatin) for Pancreatic exocrine insufficiency. open-label, none/not specified-controlled. 60 participants.
Overview
- Trial Therapeutic Area
- Gastroenterology
- Trial Disease
- Pancreatic exocrine insufficiency
- Trial Stage
- Phase IV
- Drug Modality
- Peptide/protein/enzyme
Key dates
- Initial CTIS Submission Date
- 06-09-2024
- First CTIS Authorization Date
- 15-01-2025
Trial design
open-label, none/not specified-controlled Phase IV trial across 19 sites in Poland, Portugal, Spain.
- Open Label
- Yes
- Comparator
- None/Not specified
- Target Sample Size
- 60
- Trial Duration For Participant
- 224
Eligibility
Recruits 60 Vulnerable subjects are explicitly excluded: "Vulnerable subjects (such as persons kept in detention)." Participants must be adults (18–80) and must "Provide written informed consent." No assent process for minors is described..
- Pregnancy Exclusion
- Positive β-human chorionic gonadotropin (hCG) pregnancy test, established pregnancy, or breast-feeding at Day 1 of pretreatment phase. - Women of childbearing potential not using at least one effective method of contraception (preferably one whose effectiveness is not dependent on the user, such as an intrauterine device or implant).
- Vulnerable Population
- Vulnerable subjects are explicitly excluded: "Vulnerable subjects (such as persons kept in detention)." Participants must be adults (18–80) and must "Provide written informed consent." No assent process for minors is described.
Inclusion criteria
- {"criterion_text":"- Male and female participants of any ethnic origin.\n- Participants between 18 to 80 (inclusive of both) years of age.\n- Willing to comply with the requirements of the study protocol.\n- Provide written informed consent.\n- Have previously undergone total gastrectomy.\n- Participant with pancreatic exocrine insufficiency as evidenced by clinical symptoms and confirmed by fecal elastase test.\n- Participant should not be receiving chemotherapy/radiotherapy during the last week prior to enrollment into the treatment phase.\n- Participant should not have exposure to any other investigational product within the last three months prior to enrollment into the treatment phase."}
Exclusion criteria
- {"criterion_text":"- On treatment with medications like somatostatin or aprotinin that directly influence pancreatic exocrine function.\n- Anticipated non-availability for study visits/procedures.\n- Vulnerable subjects (such as persons kept in detention).\n- Previously taken Creon or any other PERT product within last 1 week prior to Day 1 of pretreatment phase.\n- Evidence of severe cardiovascular, respiratory, urogenital, gastrointestinal, hepatic, hematological, immunological, head, ears, eyes, nose, throat (HEENT), dermatological, connective tissue, musculoskeletal, metabolic (other than CF), nutritional, endocrine, neurologic, psychiatric disease; allergy, major surgery, or any other relevant disease as revealed by history or physical examination which might limit participation in or completion of the study.\n- History of allergic reaction or hypersensitivity to pancreatin or excipients of Creon.\n- Positive β-human chorionic gonadotropin (hCG) pregnancy test, established pregnancy, or breast-feeding at Day 1 of pretreatment phase. - Women of childbearing potential not using at least one effective method of contraception (preferably one whose effectiveness is not dependent on the user, such as an intrauterine device or implant).\n- Clinically relevant acute infections, febrile disease or any acute condition (illness) two weeks prior to Day 1 of pretreatment phase, as judged by the investigator.\n- History of alcohol or drug abuse within the last 2 years.\n- Lack of willingness to have personal study-related data collected, archived, or transmitted according to protocol.\n- Lack of willingness or inability to co-operate during the conduct of the study, adequately."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Proportion of patients on stable dose of Creon, in whom there is no deterioration of nutritional status (as measured by no loss of body weight from baseline Visit).","definition_or_measurement_approach":"Measured as no loss of body weight from baseline visit (i.e., proportion of patients on stable dose of Creon with no deterioration of nutritional status measured by absence of weight loss from baseline)."}
Secondary endpoints
- {"endpoint_text":"- Change in bodyweight from baseline\n- Percentage of patients who develop symptomatic pancreatic exocrine insufficiency after gastrectomy.\n- Symptoms of pancreatic exocrine insufficiency measured (as recorded in subject diaries)\n- Nutritional parameters\n- Gastrointestinal Quality of life index (GIQLI) questionnaire\n- Treatment Emergent Adverse Events (TEAEs)\n- Change in vital signs","definition_or_measurement_approach":"Change in bodyweight from baseline: measured as change from baseline bodyweight; Percentage developing symptomatic PEI: proportion of patients developing symptomatic PEI post-gastrectomy; Symptoms: recorded in subject diaries; Nutritional parameters: unspecified nutritional measures; GIQLI: assessed via GIQLI questionnaire; TEAEs: standard recording of treatment-emergent adverse events; Change in vital signs: measured via routine vital sign assessments."}
Recruitment
- Planned Sample Size
- 60
- Recruitment Window Months
- 21
- Consent Approach
- Participants must "Provide written informed consent." ICF/SIS documents are available in country languages (documents listed for Polish, Portuguese and Spanish are present); participants are adults (18–80) so consent is provided by the participant. No assent process for minors is described.
Geography
- Total Number Of Sites
- 19
- Total Number Of Participants
- 60
Poland
- Earliest CTIS Part Ii Submission Date
- 06-01-2025
- Latest Decision Or Authorization Date
- 21-01-2025
- Processing Time Days
- 15
- Number Of Sites
- 8
- Number Of Participants
- 20
Sites
- Site Name
- Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
- Department Name
- Surgical department
- Principal Investigator Name
- Paweł Nurzyński
- Principal Investigator Email
- onkologia@cskmswia.gov.pl
- Contact Person Name
- Paweł Nurzyński
- Contact Person Email
- onkologia@cskmswia.gov.pl
- Site Name
- Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie
- Department Name
- Surgical department
- Principal Investigator Name
- Jacek Pszeniczny
- Principal Investigator Email
- chirurgia@szpital.rzezow.pl
- Contact Person Name
- Jacek Pszeniczny
- Contact Person Email
- chirurgia@szpital.rzezow.pl
- Site Name
- Formed 2 Sp. z o.o.
- Department Name
- Surgical department
- Principal Investigator Name
- Marcin Kowalski
- Principal Investigator Email
- feasibility@nzozformed2.pl
- Contact Person Name
- Marcin Kowalski
- Contact Person Email
- feasibility@nzozformed2.pl
- Site Name
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
- Department Name
- Surgical department
- Principal Investigator Name
- Piotr Richter
- Principal Investigator Email
- info@su.krakow.pl
- Contact Person Name
- Piotr Richter
- Contact Person Email
- info@su.krakow.pl
- Site Name
- Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
- Department Name
- Surgical department
- Principal Investigator Name
- Lucjan Wyrwicz
- Principal Investigator Email
- lucjan.wyrwicz@nio.gov.pl
- Contact Person Name
- Lucjan Wyrwicz
- Contact Person Email
- lucjan.wyrwicz@nio.gov.pl
- Site Name
- Szpital Miejski Specjalistyczny Im. Gabriela Narutowicza W Krakowie
- Department Name
- Surgical department
- Principal Investigator Name
- Milosz Wiktorowicz
- Principal Investigator Email
- chirurgia@narutowicz.krakow.pl
- Contact Person Name
- Milosz Wiktorowicz
- Contact Person Email
- chirurgia@narutowicz.krakow.pl
- Site Name
- Wojewodzki Szpital Im. Sw.Ojca Pio W Przemyslu
- Department Name
- Surgical department
- Principal Investigator Name
- Kamil Kuć
- Principal Investigator Email
- onkologia@wszp.pl
- Contact Person Name
- Kamil Kuć
- Contact Person Email
- onkologia@wszp.pl
- Site Name
- Szpital Specjalistyczny Im. Ludwika Rydygiera W Krakowie Sp. z o.o.
- Department Name
- Surgical department
- Principal Investigator Name
- Łukasz Matuszewski
- Principal Investigator Email
- och-sekretariat@rydygierkrakow.pl
- Contact Person Name
- Łukasz Matuszewski
- Contact Person Email
- och-sekretariat@rydygierkrakow.pl
Portugal
- Earliest CTIS Part Ii Submission Date
- 31-10-2024
- Latest Decision Or Authorization Date
- 18-03-2025
- Processing Time Days
- 138
- Number Of Sites
- 4
- Number Of Participants
- 20
Sites
- Site Name
- CCAB Centro Clinico Academico Braga Associacao
- Department Name
- Cirurgia Geral
- Principal Investigator Name
- Dina Luís
- Principal Investigator Email
- dinamluis@hb.min.saude.pt
- Contact Person Name
- Dina Luís
- Contact Person Email
- dinamluis@hb.min.saude.pt
- Site Name
- Unidade Local De Saude Do Alto Minho E.P.E.
- Department Name
- Cirurgia Geral
- Principal Investigator Name
- Marina Leite
- Principal Investigator Email
- mariana.leite@ulsam.min-saude.pt
- Contact Person Name
- Marina Leite
- Contact Person Email
- mariana.leite@ulsam.min-saude.pt
- Site Name
- Unidade Local De Saude De Gaia/Espinho E.P.E.
- Department Name
- Cirurgia Geral
- Principal Investigator Name
- Amélia Tavares
- Principal Investigator Email
- amelia.tavares@ulsge.min-saude.pt
- Contact Person Name
- Amélia Tavares
- Contact Person Email
- amelia.tavares@ulsge.min-saude.pt
- Site Name
- Unidade Local De Saude Do Alto Ave E.P.E.
- Department Name
- Oncology and visceral oncology center
- Principal Investigator Name
- Juliana Oliveira
- Principal Investigator Email
- geral@hospitaldeguimaraes.min-saude.pt
- Contact Person Name
- Juliana Oliveira
- Contact Person Email
- geral@hospitaldeguimaraes.min-saude.pt
Spain
- Earliest CTIS Part Ii Submission Date
- 02-12-2024
- Latest Decision Or Authorization Date
- 17-04-2025
- Processing Time Days
- 136
- Number Of Sites
- 7
- Number Of Participants
- 20
Sites
- Site Name
- Universidade De Santiago De Compostela
- Department Name
- Digestive medicine
- Principal Investigator Name
- Juan Enrique Domínguez-Munoz
- Principal Investigator Email
- dig.chus.santiago@sergas.es
- Contact Person Name
- Juan Enrique Domínguez-Munoz
- Contact Person Email
- dig.chus.santiago@sergas.es
- Site Name
- Hospital General Universitario Gregorio Maranon
- Department Name
- Oncology
- Principal Investigator Name
- Laura Gómez Lanz
- Principal Investigator Email
- laura.gomezlanz@gmail.com
- Contact Person Name
- Laura Gómez Lanz
- Contact Person Email
- laura.gomezlanz@gmail.com
- Site Name
- Hospital Universitario Virgen De Las Nieves
- Department Name
- Surgery
- Principal Investigator Name
- Monica Mogollón
- Principal Investigator Email
- monica.mogollon.sspa@juntadeandalucia.es
- Contact Person Name
- Monica Mogollón
- Contact Person Email
- monica.mogollon.sspa@juntadeandalucia.es
- Site Name
- Hospital Universitario Hm Sanchinarro
- Department Name
- Oncology
- Principal Investigator Name
- Rafael Álvarez Gallego
- Principal Investigator Email
- ralvarezgallego@hmhospitales.com
- Contact Person Name
- Rafael Álvarez Gallego
- Contact Person Email
- ralvarezgallego@hmhospitales.com
- Site Name
- Bellvitge University Hospital
- Department Name
- General and Digestive Surgery
- Principal Investigator Name
- Mónica Miró
- Principal Investigator Email
- mmiro@bellvitgehospital.cat
- Contact Person Name
- Mónica Miró
- Contact Person Email
- mmiro@bellvitgehospital.cat
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- General and Digestive Surgery
- Principal Investigator Name
- Javier Martínez Caballero
- Principal Investigator Email
- jmcaballero@salud.madrid.org
- Contact Person Name
- Javier Martínez Caballero
- Contact Person Email
- jmcaballero@salud.madrid.org
- Site Name
- Hospital De La Santa Creu I Sant Pau
- Department Name
- Surgery
- Principal Investigator Name
- Santiago Sánchez Cabús
- Principal Investigator Email
- ssanchezca@santpau.cat
- Contact Person Name
- Santiago Sánchez Cabús
- Contact Person Email
- ssanchezca@santpau.cat
Sponsor
Primary sponsor
- Full Name
- BGP Products Operations GmbH
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Contract research organisations
- Name
- Astrum CRO Germany GmbH
- Responsibilities
- codes: 1,10,12,2,5,6; contact: Germany@AstrumCRO.com
- Name
- Almac Clinical Services Limited
- Responsibilities
- codes: 14; 15: Secondary Packaging and Release of Pancreas Powder Capsules with gastroresistant Pellets (final IMP); contact: acsregulatorycompliance@almacgroup.com
- Name
- Inductive Quotient Analytics India Private Limited
- Responsibilities
- codes: 7; contact: hello@inductivequotient.com
Third parties
- {"country":"Spain","full_name":"Astrum Cro Spain S.L.","duties_or_roles":"codes: 1,2","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"Germany","full_name":"Labor Dr. Spranger","duties_or_roles":"codes: 4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Clinical Services Limited","duties_or_roles":"codes: 14; 15: Secondary Packaging and Release of Pancreas Powder Capsules with gastroresistant Pellets (final IMP)","organisation_type":"Pharmaceutical company"}
- {"country":"India","full_name":"Inductive Quotient Analytics India Private Limited","duties_or_roles":"codes: 7","organisation_type":"Pharmaceutical company"}
- {"country":"Portugal","full_name":"Blueclinical Investigacao E Desenvolvimento Em Saude Lda.","duties_or_roles":"codes: 1,2","organisation_type":"Pharmaceutical company"}
- {"country":"Poland","full_name":"Brillance Sp. z o.o.","duties_or_roles":"codes: 1,2","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"Astrum CRO Germany GmbH","duties_or_roles":"codes: 1,10,12,2,5,6","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Creon® 25000 Capsules
- Active Substance
- Pancreas powder (pancreatin)
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- ORAL USE
- Route
- ORAL USE
- Authorisation Status
- Marketing authorisation PL 46302/0029
- Maximum Dose
- 325000 U unit(s) per day
Related trials
Other published trials that may interest you.