Dose-ranging Study to Evaluate Efficacy of SLV339 in Pancreatic Exocrine Insufficiency Due to Chronic Pancreatitis

Solvay

Status and phase

Terminated

Phase 2

Conditions

Pancreatic Exocrine Insufficiency Due to Chronic Pancreatitis

Treatments

Drug: Placebo

Drug: Recombinant Microbial Lipase SLV339

Study type

Interventional

Funder types

Industry

Identifiers

2007-000375-42

S339.2.001

Details and patient eligibility

About

This study is to estimate the efficacy of a number of doses in patients with pancreatic insufficiency

Enrollment

56 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subject > 18 years;
Pancreatic exocrine insufficiency confirmed and documented in medical history by either a pathophysiological direct or indirect pancreatic function test or clinical symptoms of steatorrhea stool fat that resolved or improved substantially upon pancreatic enzyme supplementation;
Patients on a stable daily dose of pancreatic enzymes for 3 months;
Subjects with CP with or without partial pancreatectomy due to CP, confirmed in medical history by either CT , ERCP, plain film with pancreatic calcifications, ultra-sonography (calcifications, duct dilatation), magnetic resonance pancreatography, endoscope ultrasound, other radiological diagnosis captured by tools such as Cambridge classification and /or histology;
CFA < 80% at time of randomization

Exclusion criteria

Evidence of major surgery (except gall bladder removal or appendectomy) or other relevant diseases as revealed by history, physical examination, and laboratory assessments which may interfere with the absorption, distribution, metabolism or elimination of the study drug or constitute a risk factor when taking the study medication;
Investigational drug intake within 90 days prior to the pre-assessment visit;
Ileus or acute abdomen;
Allergic disease such as hypersensitivity pneumonitis, aspergillus mediated asthma or allergic broncho-pulmonary aspergillosis;
Stenosis or regurgitation of the esophagus or stomach;
Known HIV infection, acute phase of CP