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

Phase 2

Terminated

• Conditions: Pancreatic Exocrine Insufficiency Due to Chronic Pancreatitis
• Interventions: Drug: Placebo; Drug: Recombinant Microbial Lipase SLV339

• Registration Number: NCT00630279
• Lead Sponsor: Solvay Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-02-22
• Study First Submitted QC: 2008-02-26
• Study First Posted: 2008-03-06
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Status Verified: 2009-08
• Last Update Submitted: 2009-08-04
• Last Update Posted: 2009-08-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Placebo	-
2	Recombinant Microbial Lipase SLV339	-
3	Recombinant Microbial Lipase SLV339	-
4	Recombinant Microbial Lipase SLV339	-

Primary Outcome Measures

Name	Time	Method
CFA (Coefficient of Fat Absorption)	from baseline to end of 7 days treatment

Secondary Outcome Measures

Name	Time	Method
CNA, stool fat, stool weight, nutritional parameters, clinical symptomatology	from baseline to end of 7 days treatment

Trial Locations

Locations (50)

Site 4205; 🇨🇿 Praha, Czech Republic

Site 3606; 🇭🇺 Pecs, Hungary

Site 4810; 🇵🇱 Gdansk, Poland

Site 3703; 🇱🇻 Riga, Latvia

Site 4811; 🇵🇱 Lodz, Poland

Site 3612; 🇭🇺 Bekescsaba, Hungary

Site 3615; 🇭🇺 Debrecen, Hungary

Site 4201; 🇨🇿 Tabor, Czech Republic

Site 4204; 🇨🇿 Usti nad Orlici, Czech Republic

Site 3701; 🇱🇻 Riga, Latvia

Site 3705; 🇱🇻 Riga, Latvia

Site 4809; 🇵🇱 Gdansk, Poland

Site 4503; 🇩🇰 Herning, Denmark

Site 3611; 🇭🇺 Szentes, Hungary

Site 4203; 🇨🇿 Hradec Kralove, Czech Republic

Site 4202; 🇨🇿 Praha 8, Czech Republic

Site 3614; 🇭🇺 Budapest, Hungary

Site 3604; 🇭🇺 Gyula, Hungary

Site 4206; 🇨🇿 Brno, Czech Republic

Site 3607; 🇭🇺 Budapest, Hungary

Site 4802; 🇵🇱 Skierniewice, Poland

Site 3613; 🇭🇺 Sopron, Hungary

Site 3609; 🇭🇺 Szeged, Hungary

Site 3702; 🇱🇻 Daugavpils, Latvia

Site 0901; 🇷🇺 Moscow, Russian Federation

Site 3603; 🇭🇺 Vac, Hungary

Site 4502; 🇩🇰 Hvidovre, Denmark

Site 4501; 🇩🇰 Odense, Denmark

Site 3610; 🇭🇺 Eger, Hungary

Site 3602; 🇭🇺 Dunaujvaros, Hungary

Site 3601; 🇭🇺 Szekszard, Hungary

Site 3608; 🇭🇺 Tatabanya, Hungary

Site 3605; 🇭🇺 Zalaegerszeg, Hungary

Site 4805; 🇵🇱 Katowice, Poland

Site 4808; 🇵🇱 Bialystok, Poland

Site 0904; 🇷🇺 Moscow, Russian Federation

Site 4807; 🇵🇱 Poznan, Poland

Site 4801; 🇵🇱 Warszawa, Poland

Site 4813; 🇵🇱 Wroclaw, Poland

Site 4806; 🇵🇱 Warszawa, Poland

Site 0908; 🇷🇺 Moscow, Russian Federation

Site 4812; 🇵🇱 Wroclaw, Poland

Site 0909; 🇷🇺 Moscow, Russian Federation

Site 0910; 🇷🇺 Moscow, Russian Federation

Site 4602; 🇸🇪 Göteborg, Sweden

Site 4603; 🇸🇪 Stockholm, Sweden

Site 4601; 🇸🇪 Umea, Sweden

Site 4804; 🇵🇱 Sopot, Poland

Site 3704; 🇱🇻 Riga, Latvia

Site 4814; 🇵🇱 Poznan, Poland