Clinical trial • Phase III • Gastroenterology

Pancreas powder (pancreatin) for Pancreatic exocrine insufficiency | Post-pancreatectomy pancreatic exocrine insufficiency

Phase III trial of Pancreas powder (pancreatin) for Pancreatic exocrine insufficiency | Post-pancreatectomy pancreatic exocrine insufficiency.

Overview

Trial Therapeutic Area
Gastroenterology
Trial Disease
Pancreatic exocrine insufficiency | Post-pancreatectomy pancreatic exocrine insufficiency
Trial Stage
Phase III
Drug Modality
Peptide/protein/enzyme

Key dates

Initial CTIS Submission Date
12-07-2024
First CTIS Authorization Date
05-11-2024

Trial design

open-label, none/not specified-controlled, adaptive Phase III trial across 26 sites in Germany, Spain, Poland.

Open Label
Yes
Comparator
None/Not specified
Adaptive
True - dose-escalation (step-up) adaptive elements: patients begin with an initial treatment period and are re-evaluated at predefined intervals (after 2 weeks and after subsequent periods). Patients with persistent PEI symptoms (as assessed by CGI and nutritional deficit criteria) receive the next step-up dose for the next period; escalation continues until symptoms resolve or the maximum study dose is reached. Interim evaluations occur at each treatment-period boundary; stopping of escalation occurs when patient has no remaining PEI symptoms or when maximum study dose reached.
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
75
Trial Duration For Participant
196

Eligibility

Recruits 75 Vulnerable subjects (such as persons kept in detention) are expressly listed under exclusion criteria. Inclusion requires written informed consent from participants (adults aged 18–80); the trial enrols adults only, so no assent for minors is described..

Pregnancy Exclusion
Positive β-human chorionic gonadotropin (β-HCG) pregnancy test, established pregnancy, or breastfeeding at screening.
Vulnerable Population
Vulnerable subjects (such as persons kept in detention) are expressly listed under exclusion criteria. Inclusion requires written informed consent from participants (adults aged 18–80); the trial enrols adults only, so no assent for minors is described.

Inclusion criteria

  • {"criterion_text":"- Male and female subjects of any ethnic origin."}
  • {"criterion_text":"- Between 18 to 80 (inclusive of both) years of age."}
  • {"criterion_text":"- Have previously undergone total pancreatectomy, performed at least 2 weeks prior to start of the study. Patients with surgery due to pancreatic cancer can be considered for study inclusion even if on adjuvant cancer treatment (i.e., chemotherapy and radiation therapy)"}
  • {"criterion_text":"- Evaluated as having related PEI symptoms by the investigator: - CGI of at least moderate and - Presence of nutritional deficit (at least one parameter from lab panel out of normal range)."}
  • {"criterion_text":"- On treatment with Proton Pump Inhibitors (if patient is not pre-treated, treatment should be started at Visit 1)."}
  • {"criterion_text":"- Willing and able to comply with the requirements of the study protocol (including completion of an eDiary throughout the study)."}
  • {"criterion_text":"- Provide written informed consent."}
  • {"criterion_text":"- Estimated life expectancy in consistency with the study duration."}

Exclusion criteria

  • {"criterion_text":"- PEI due non-surgical conditions like pancreatitis, unresectable pancreatic cancer, cystic fibrosis, celiac disease, and Zollinger-Ellison syndrome."}
  • {"criterion_text":"- 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) at least four weeks prior to dosing and continuing at least 4 weeks following the last treatment."}
  • {"criterion_text":"- Clinically relevant acute infections, febrile disease or any acute condition (illness) two weeks prior to screening, as judged by the investigator."}
  • {"criterion_text":"- Lack of willingness to have personal study-related data collected, archived, or transmitted according to protocol."}
  • {"criterion_text":"- Lack of willingness or inability to co-operate adequately."}
  • {"criterion_text":"- Anticipated non-availability for study visits/procedures."}
  • {"criterion_text":"- Vulnerable subjects (such as persons kept in detention)."}
  • {"criterion_text":"- Gastrointestinal symptoms similar to PEI due to other conditions."}
  • {"criterion_text":"- Chemotherapy/radiotherapy dose during the last week prior to screening."}
  • {"criterion_text":"- On PERT with the same or higher doses than during the first treatment period (lower doses are allowed)."}
  • {"criterion_text":"- History of alcohol or drug abuse within the last 2 years which would interfere with the subject’s proper completion of the protocol assignment, as judged by the investigator."}
  • {"criterion_text":"- Exposure to another investigational product within the last three months prior to screening."}
  • {"criterion_text":"- Evidence of severe cardiovascular, respiratory, urogenital, gastrointestinal (including colic fibrosis), hepatic, hematological, immunological, head, ears, eyes, nose, throat (HEENT), dermatological, connective tissue, musculoskeletal, metabolic (including hyperuricemia), 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."}
  • {"criterion_text":"- History of allergic reaction or hypersensitivity to pancreatin or excipients of Creon."}
  • {"criterion_text":"- Positive β-human chorionic gonadotropin (β-HCG) pregnancy test, established pregnancy, or breastfeeding at screening."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Percentage of patients treated with higher than approved final treatment doses.","definition_or_measurement_approach":"Measure: percentage of patients treated with final treatment doses higher than approved; main objective clarifies threshold of interest as patients requiring doses higher than 70,000 U per main meal."}

Secondary endpoints

  • {"endpoint_text":"- CGI (investigator), Nutritional laboratory parameters, Diabetes parameters (glucose and HbA1c levels, insulin doses), Clinical symptoms (abdominal pain, flatulence, stool consistency; diary), stool frequency, average daily stool frequency during treatment period (diary), time course","definition_or_measurement_approach":"Measurements include investigator Clinical Global Impression (CGI), laboratory nutritional panels, diabetes parameters (glucose, HbA1c, insulin doses), patient-reported clinical symptom diary entries (abdominal pain, flatulence, stool consistency), stool frequency and average daily stool frequency assessed from eDiary over the treatment period and time course analysis."}
  • {"endpoint_text":"- Body Mass Index (BMI) and body weight, Improvement in Quality of Life (QoL), Pancreatic Exocrine Insufficiency Questionnaire (PEI-Q), change from baseline to end of treatment","definition_or_measurement_approach":"Measurements: BMI and body weight at baseline and end of treatment; QoL assessed by SF-36; disease-specific PEI-Q questionnaire; analyze change from baseline to end of treatment."}
  • {"endpoint_text":"- Evaluation of vital signs","definition_or_measurement_approach":"Standard assessment of vital signs (as recorded at study visits)."}
  • {"endpoint_text":"- Incidence of Adverse Events (AEs) – PERT related","definition_or_measurement_approach":"Collection and reporting of adverse events, with classification of events related to pancreatic enzyme replacement therapy (PERT)."}

Recruitment

Digital Remote Recruitment
True - study recruitment materials include a 'Text Homepage' recruitment document (Poland) and patient-facing electronic materials; patient-facing materials (flyers and study information) are available digitally in multiple languages.
Planned Sample Size
75
Recruitment Window Months
30
Consent Approach
Written informed consent is required from each participant (ICF/L1_SIS and ICF documents provided). Consent is obtained from adult participants (eligible ages 18–80). Subject information sheets and ICF documents and patient-facing materials are provided in multiple languages (English, German, Spanish, Polish, French as available in the submission documents). Country-specific ICF and recruitment arrangements are provided for Germany, Spain and Poland.

Methods

  • Patient-facing recruitment flyers (K2_Recruitment Material Patient Flyer) available in multiple languages (DE, ENG, ESP, PL) for patient recruitment.
  • Country-specific recruitment and informed consent arrangement documents (K1_Recruitment and informed consent arrangement) describing local recruitment arrangements (documents exist for Germany, Spain, Poland).
  • Text for study homepage (document: K2_Recruitment Material_Text Hompage_V1) used for online recruitment content (Poland).

Geography

Total Number Of Sites
26
Total Number Of Participants
75

Germany

Earliest CTIS Part Ii Submission Date
05-08-2024
Latest Decision Or Authorization Date
18-03-2026
Processing Time Days
590
Number Of Sites
8
Number Of Participants
25

Sites

Site Name
Helios Universitaetsklinikum Wuppertal
Department Name
"Center for Clinical Research at the Philipp Klee Institute for Clinical Pharmacology "
Contact Person Name
Florian Gebauer
Site Name
Justus-Liebig-Universität Gießen — JLU
Department Name
Clinic for General, Visceral, Thorax, Transplant and Pediatric Surgery
Contact Person Name
Martin Reichert
Site Name
Katholisches Klinikum Bochum gGmbH
Department Name
General and visceral surgery
Contact Person Name
Michael Klages
Site Name
Muenchen Klinik gGmbH
Department Name
Oncology and visceral oncology center
Contact Person Name
Martin Fuchs
Site Name
Vinzenzkrankenhaus Hannover GmbH
Department Name
Allgemeinchirugie
Contact Person Name
Moritz Kleine
Site Name
DRK Kliniken Berlin
Department Name
Clinic for Internal Medicine - Gastroenterology, Hematology and Oncology, Nephrology
Contact Person Name
René Pschowski
Site Name
Universitätsklinikum Münster
Department Name
Clinic for General, Visceral and Transplant Surgery
Contact Person Name
Andreas Andreou
Contact Person Email
andreas.andreou@ukmuenster.de
Site Name
Klinikum rechts der Isar der TU Muenchen AöR
Department Name
Surgical Clinic and Polyclinic
Contact Person Name
Daniel Reim
Contact Person Email
daniel.reim@tum.de

Spain

Earliest CTIS Part Ii Submission Date
08-10-2024
Latest Decision Or Authorization Date
18-03-2026
Processing Time Days
526
Number Of Sites
10
Number Of Participants
25

Sites

Site Name
Hospital Universitario Regional De Malaga
Department Name
Digestive medicine
Contact Person Name
Miguel Jímenez Pérez
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Oncology
Contact Person Name
Andres Jesús Munoz Martín
Contact Person Email
ajmunoz.hquqm@salud.madrid.org
Site Name
Hospital Universitario 12 De Octubre
Department Name
Oncology
Contact Person Name
Jorge Adeva
Contact Person Email
unidaddigestivo.imas12@h12o.es
Site Name
Universidade De Santiago De Compostela
Department Name
Digestive medicine
Contact Person Name
Juan Enrique Domínguez-Munoz
Contact Person Email
dig.chus.santiago@sergas.es
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Digestive medicine
Contact Person Name
Ana García García de Paredes
Contact Person Email
gastroen.hrc@salud.madrid.org
Site Name
Hospital Universitario Hm Sanchinarro
Department Name
Oncology
Contact Person Name
Rafael Álvarez Gallego
Site Name
Hospital Universitario Virgen De Las Nieves
Department Name
Surgery
Contact Person Name
Mario Serradilla
Contact Person Email
mserradilla@ugr.es
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Surgery
Contact Person Name
Santiago Sánchez Cabús
Contact Person Email
ssanchezca@santpau.cat
Site Name
Bellvitge University Hospital
Department Name
Surgery
Contact Person Name
Juli Busquets
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
Surgery
Contact Person Name
Juan Antonio Bellido Iuque
Contact Person Email
j_bellido_l@hotmail.com

Poland

Earliest CTIS Part Ii Submission Date
07-10-2024
Latest Decision Or Authorization Date
18-03-2026
Processing Time Days
527
Number Of Sites
8
Number Of Participants
25

Sites

Site Name
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
Department Name
Kierownik Kliniki Chorób Wewnętrznych i Gastroenterologii z Pododdziałem Leczenia Nieswoistych
Contact Person Name
Grażyna Maria Rydzewska-Wyszkowska
Site Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwersytecki Szpital Kliniczny Nr 1 Im. Norberta Barlickiego Uniwersytetu Medycznego W Lodzi
Department Name
Zastępca Kierownika Oddziału Klinicznego Chirurgii Ogólnej, Transplantacyjnej, Gastroenterologicznej
Contact Person Name
Piotr Hogendorf
Contact Person Email
piotr.hogendorf@umed.lodz.pl
Site Name
Szpital Uniwersytecki Nr 1 Im. Dr. A. Jurasza W Bydgoszczy
Department Name
Kierownik Kliniki Chirurgii Ogólnej, Chirurgii Wątroby i Chirurgii Transplantacyjnej
Contact Person Name
Maciej Słupski
Contact Person Email
sekretariat@jurasza.pl
Site Name
udwik Rydygier Memorial Specialized Hospital in Kraków Ltd
Department Name
Surgical Unit
Contact Person Name
Michal Wysocki
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
Kierownik Kliniki Chirurgii Nowotworów Układu Pokarmowego i Guzów Neuroendokrynnych
Contact Person Name
Tomasz Olesinski
Site Name
Uniwersyteckie Centrum Kliniczne Im. Prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego W Katowicach
Department Name
Lekarz kierujący Oddziałem Chirurgii Przewodu Pokarmowego UCK Kierownik Kliniki Chirurgii Przewodu
Contact Person Name
Slawomir Mrowiec
Contact Person Email
sekretariat@uck.katowice.pl
Site Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
Department Name
p.o. Kierownika Oddziału Klinicznego Chirurgii Ogólnej, Onkologicznej, Gastroenterologicznej
Contact Person Name
Piotr Richter
Contact Person Email
info@su.krakow.pl
Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
Profesor Gdańskiego Uniwersytetu Medycznego w Klinice Chirurgii Onkologicznej, Transplantacyjnej
Contact Person Name
Stanislaw Hać
Contact Person Email
info@uck.gda.pl

Sponsor

Primary sponsor

Full Name
MEDA Pharma GmbH & Co. KG
Organisation Type
Pharmaceutical company
Country Of Registered Address
Germany

Contract research organisations

Name
Almac Clinical Services Limited
Responsibilities
sponsorDuties codes: 14
Name
Astrum CRO Germany GmbH
Responsibilities
sponsorDuties codes: 1,12,2,5,6
Name
Astrum Cro Spain S.L.
Responsibilities
sponsorDuties codes: 1,2

Third parties

  • {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Clinical Services Limited","duties_or_roles":"sponsorDuties codes: 14","organisation_type":"Pharmaceutical company"}
  • {"country":"Poland","full_name":"Brillance Sp. z o.o.","duties_or_roles":"sponsorDuties codes: 1,2","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"AB Cube Germany GmbH","duties_or_roles":"sponsorDuties codes: 7","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Spain","full_name":"Astrum Cro Spain S.L.","duties_or_roles":"sponsorDuties codes: 1,2","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Germany","full_name":"Astrum CRO Germany GmbH","duties_or_roles":"sponsorDuties codes: 1,12,2,5,6","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Labor Dr. Spranger","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Laboratory/Research/Testing facility"}

Investigational products

Investigational Product Name
Kreon 35 000 Ph. Eur. Lipase Einheiten, magensaftresistente Hartkapseln
Active Substance
Pancreas powder (pancreatin)
Modality
Peptide/protein/enzyme
Routes Of Administration
ORAL USE
Route
ORAL
Authorisation Status
Authorised (marketing authorisation information present; MR project references present)
Maximum Dose
560000 U unit(s) per day

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