Role of Pancreatic Enzyme Replacement Therapy (PERT) (Creon®) for Pancreatic Exocrine Insufficiency (PEI) after Pancreatic Surgery

Overview

Sponsor-declared trial summary

Key facts

Sponsor

MEDA Pharma GmbH & Co. KG

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

Trial duration

7 Jan 2025 → ongoing

Decision date (initial)

2024-11-05

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

MEDA Pharma GmbH & Co. KG (A Viatris Company) Benzstr. 1, 61352 Bad Homburg, Germany

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Dose response

To investigate the percentage of patients requiring doses higher than 70k U per main meal.

Secondary objectives 1

1. To observe the effect of different doses of Creon on disease-related PEI symptoms, nutritional parameters, and diabetes parameters over time.

Conditions and MedDRA coding

Male and female patients aged ≥ 18 to ≤ 85 years with a total pancreatectomy with Pancreatic Exocrine Insufficiency (PEI).

Study design 4 periods

Regulatory references

Scientific advice from competent authorities

Federal Institute For Drugs And Medical Devices

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Male and female subjects of any ethnic origin.
2. Between 18 to 80 (inclusive of both) years of age.
3. 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)
4. 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).
5. On treatment with Proton Pump Inhibitors (if patient is not pre-treated, treatment should be started at Visit 1).
6. Willing and able to comply with the requirements of the study protocol (including completion of an eDiary throughout the study).
7. Provide written informed consent.
8. Estimated life expectancy in consistency with the study duration.

Exclusion criteria 15

1. PEI due non-surgical conditions like pancreatitis, unresectable pancreatic cancer, cystic fibrosis, celiac disease, and Zollinger-Ellison syndrome.
2. Gastrointestinal symptoms similar to PEI due to other conditions.
3. Chemotherapy/radiotherapy dose during the last week prior to screening.
4. On PERT with the same or higher doses than during the first treatment period (lower doses are allowed).
5. 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.
6. Exposure to another investigational product within the last three months prior to screening.
7. 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.
8. History of allergic reaction or hypersensitivity to pancreatin or excipients of Creon.
9. Positive β-human chorionic gonadotropin (β-HCG) pregnancy test, established pregnancy, or breastfeeding at screening.
10. 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.
11. Clinically relevant acute infections, febrile disease or any acute condition (illness) two weeks prior to screening, as judged by the investigator.
12. Lack of willingness to have personal study-related data collected, archived, or transmitted according to protocol.
13. Lack of willingness or inability to co-operate adequately.
14. Anticipated non-availability for study visits/procedures.
15. Vulnerable subjects (such as persons kept in detention).

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Percentage of patients treated with higher than approved final treatment doses.

Secondary endpoints 4

1. 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
2. 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
3. Evaluation of vital signs
4. Incidence of Adverse Events (AEs) – PERT related

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

MEDA Pharma GmbH & Co. KG

Sponsor organisation

MEDA Pharma GmbH & Co. KG

Address

Benzstrasse 1

City

Bad Homburg

Postcode

61352

Country

Germany

Scientific contact point

Organisation

MEDA Pharma GmbH & Co. KG

Contact name

EUClinicalTrials@viatris

Public contact point

Organisation

MEDA Pharma GmbH & Co. KG

Contact name

EUClinicalTrials@viatris

Third parties 6

Locations

3 EU/EEA countries · 28 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 78 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

11 submissions — initial application plus substantial / non-substantial modifications