Health TrialsbyHealthPanel

The Pancreatic Enzymes After Gastrectomy Trial

ConditionGastrectomy
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Leipzig

About this trial

This trial evaluates the effects (e.g. on quality of life, weight) of NORTASE® compared to standard care of patients who have undergone gastrectomy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Gastrectomy (total and partial distal); at least > 50 % of the stomach must be resected

Age 18 or older

Written informed consent

Disqualifiers

Indication for pancreas enzyme therapy

Gastrectomy with palliative intention

UICC (Union for International Cancer Control) Stage IV gastric malignancy

Malnutrition of other aetiology

Trial design

Design model

Parallel

Treatments tested in this trial

  • NORTASE®

    Drug

    10-15 capsules of NORTASE® per day - over 6 months

  • Placebo

    Drug

    10-15 capsules of placebo per day - over 6 months

Treatment groups

188 Participants
are divided into 2 treatment groups
Group A: NORTASE®Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Disease specific quality of life (QOL)

This is the physical sub-score from the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC-QLQ-C30) and ranges from 0 (lowest physical functioning) to 100 (highest physical functioning).

Time frame
6 months

Secondary outcomes

1

Nutritional supplementation or weight loss

Proportion of patients who receive supplemental nutrition after the run-in period of 3 weeks or have \> 10% weight loss at six months

Time frame
6 months
2

Weight

Percent weight-change at six months (weight in kilograms)

Time frame
6 months
3

Serum haemoglobin

Concentration of serum haemoglobin

Time frame
6 months
4

Total protein

Concentration of total protein

Time frame
6 months

Other outcomes

1

Faecal elastase-1

Concentration of faecal elastase-1

Time frame
6 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Leipzig

Lead sponsor

Source ClinicalTrials.gov
Apply now