The Pancreatic Enzymes after Gastrectomy Trial

The primary objective of the study titled "The Pancreatic Enzymes after Gastrectomy Trial" is to evaluate whether **enzyme supplementation** with every meal can lead to improved disease-specific quality of life at six months post-gastrectomy. This is clinically relevant as patients who have undergone gastrectomy, whether total or partial, often experience digestive challenges that can significantly impact their quality of life. The study aims to determine if the administration of pancreatic enzymes, specifically **amylase**, **protease**, and **rizolipase**, in the form of a hard capsule known as Nortase®, can alleviate these issues and enhance patient outcomes.

The clinical trial involves **patients after gastrectomy**, both total and partial, with the primary objective of assessing whether enzyme supplementation with every meal can improve disease-specific quality of life six months post-surgery. The study population includes adults aged 18 and older, encompassing both male and female participants. The trial does not focus on a vulnerable population. The sponsor has not provided information regarding the total number of participants. Participants were selected based on their surgical history of gastrectomy, and no specific lifestyle considerations such as diet or physical activity were highlighted in the selection process.

The clinical trial is designed to evaluate the efficacy of **enzyme supplementation** in improving disease-specific quality of life in patients who have undergone gastrectomy, either total or partial. This study is a **randomized, double-blind, controlled** trial, ensuring that neither the participants nor the researchers know who is receiving the active treatment or the placebo, thereby minimizing bias. The trial will span approximately 30 months, with an estimated recruitment start date of June 1, 2023, and an anticipated end date of November 30, 2025.

Participants will be required to attend several study visits throughout the trial. The initial visit, known as the inclusion or screening visit, will determine eligibility based on criteria such as having undergone a gastrectomy and being 18 years or older. Following successful screening, participants will be randomly assigned to receive either the active treatment, **Nortase®** (containing amylase, protease, and rizolipase), or a placebo. The treatment will be administered orally in the form of hard capsules with a maximum daily dose of 15 capsules, not exceeding a total dose of 2700 capsules over the treatment period.

Subsequent follow-up visits will be scheduled to monitor the participants' progress and adherence to the treatment regimen. These visits will also serve to collect data on the primary endpoint, which is the disease-specific quality of life at six months post-gastrectomy, assessed using the physical sub-score of the EORTC-QLQ-C30. The end-of-study visit will conclude the trial for each participant, where final assessments will be conducted.

The expected length of participant involvement is up to six months, corresponding to the maximum treatment period. Conditions that may lead to early termination from the study include non-compliance with the study protocol, adverse reactions to the treatment, or withdrawal of consent by the participant. The trial is categorized as a Phase III trial, indicating it is a late-stage study aimed at confirming the treatment's effectiveness and monitoring side effects in a larger patient population.

The clinical trial involves the administration of **Nortase®**, an experimental medication formulated as a hard capsule. This pharmaceutical product contains the active substances **amylase**, **protease**, and **rizolipase**, which are classified under the ATC code A09AA02, indicating their role as multienzymes. The medication is manufactured by REPHA GMBH BIOLOGISCHE ARZNEIMITTEL and is authorized in Germany. The route of administration for Nortase® is oral, with a maximum daily dose of 15 capsules and a total maximum dose of 2700 capsules over the treatment period. The maximum treatment duration is six months. For the purpose of blinding, study-specific secondary packaging and labeling will be performed.

The trial also includes a **placebo** treatment, referred to as "Placebo to Test." This placebo is used as a comparator to evaluate the efficacy of Nortase®. The placebo does not contain any active substances and is not associated with a specific pharmaceutical form or route of administration. It serves to maintain the integrity of the study by providing a control against which the effects of the experimental medication can be measured.

Efficacy in the clinical trial titled "The Pancreatic Enzymes after Gastrectomy Trial" will be assessed primarily through the evaluation of disease-specific quality of life (QOL) at 6 months post-gastrectomy. The primary endpoint is defined as the physical sub-score of the EORTC-QLQ-C30, a validated instrument for measuring QOL in cancer patients. This assessment will determine whether enzyme supplementation with every meal after gastrectomy leads to improved QOL.