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Creon after gastrectomy BMI study
2004-005012-80Phase 3
Key facts
- Status
- Completed
- Start
- Jan 2005
- Countries
- 1
- Sponsor
- Solvay Pharmaceuticals
- Modality
- Replacement Enzymes → Therapeutic Enzymes → Recombinant Proteins and Enzymes, Blood Coagulation Factors → Therapeutic Enzymes → Recombinant Proteins and Enzymes, Insulin and Analogs → Hormones & Growth Factors → Recombinant Proteins and Enzymes
- Drugs
- pancreatin
- Conditions
- postgastrectomy syndrome (PGS)exocrine pancreatic insufficiency (EPI)
01
Overview
Phase 3, randomised, double-blind trial in postgastrectomy syndrome (PGS) and exocrine pancreatic insufficiency (EPI) comparing Creon with Placebo (2 arms). Primary endpoint: Change from baseline to last value in body mass index after 6 months. Started Jan 2005; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Creon
Pancreatic enzyme supplementation with Creon 25 000 Minimicrospheres.
Placebo
Placebo comparator arm.
03
Who it enrols
Adults aged 18 years or older with prior total or subtotal gastrectomy (Roux-en-Y anastomosis for subtotal gastrectomy) were eligible. Key exclusions included progressive tumor disease or metastases, temporary inability to maintain adequate oral nutrition after gastrectomy, known pancreatin allergy, established pancreatic exocrine insufficiency from other causes, chronic organic intestinal disease, recent investigational drug exposure, alcohol or drug abuse, and likely noncompliance.
04
Endpoints
Primary
Change from baseline to last value in body mass index after 6 months
Secondary
Body composition
Stool fat
Coefficient of fat absorption
Stool weight
Clinical global impression of disease symptoms
Quality of life
Gastrointestinal clinical symptoms
Diary-based stool frequency
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