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Dose-ranging Study to Evaluate Efficacy of SLV339 in Pancreatic Exocrine Insufficiency Due to Chronic Pancreatitis | Clinical Trials | Clareo Health

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

A Multi-center, Single-blind, Parallel-design, Randomized, Placebo-controlled, Dose-ranging Study to Evaluate Oral Recombinant Microbial Lipase Efficacy in Patients With Pancreatic Exocrine Insufficiency Due to Chronic Pancreatitis

NCT00630279•Solvay Pharmaceuticals

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - No limit years

Sex

ALL

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

Locations (50)

Site 4206

Brno, Czechia

Site 4203

Hradec Králové, Czechia

Site 4202

Prague, Czechia

Site 4205

Prague, Czechia

Site 4201

Tábor, Czechia

Site 4204

Ústí nad Orlicí, Czechia

Site 4503

Herning, Denmark

Site 4502

Hvidovre, Denmark

Site 4501

Odense, Denmark

Site 3612

Békéscsaba, Hungary

Key Dates

Start Date

February 1, 2008

Primary Completion Date

March 1, 2009

Completion Date

March 1, 2009

Last Updated

August 6, 2009

Enrollment

ACTUAL participants

Conditions

Pancreatic Exocrine Insufficiency Due to Chronic Pancreatitis

Interventions

Placebo

DRUG

Recombinant Microbial Lipase SLV339

DRUG

Recombinant Microbial Lipase SLV339

DRUG

Recombinant Microbial Lipase SLV339

DRUG