Dose-ranging Study to Evaluate Efficacy of SLV339 in Pancreatic Exocrine Insufficiency Due to Chronic Pancreatitis
NCT ID: NCT00630279
Last Updated: 2009-08-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
56 participants
INTERVENTIONAL
2008-02-29
2009-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
Placebo
Placebo
2
Recombinant Microbial Lipase SLV339
oral, 150 mg/d, 7 days treatment
3
Recombinant Microbial Lipase SLV339
oral, 300 mg/d, 7 days treatment
4
Recombinant Microbial Lipase SLV339
oral, 600 mg/d, 7 days treatment
Interventions
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Placebo
Placebo
Recombinant Microbial Lipase SLV339
oral, 150 mg/d, 7 days treatment
Recombinant Microbial Lipase SLV339
oral, 300 mg/d, 7 days treatment
Recombinant Microbial Lipase SLV339
oral, 600 mg/d, 7 days treatment
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Solvay Pharmaceuticals
INDUSTRY
Responsible Party
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Solvay Pharmaceuticals
Principal Investigators
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Global Clinical Director Solvay
Role: STUDY_DIRECTOR
Solvay Pharmaceuticals
Locations
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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
Site 3607
Budapest, , Hungary
Site 3614
Budapest, , Hungary
Site 3615
Debrecen, , Hungary
Site 3602
Dunaújváros, , Hungary
Site 3610
Eger, , Hungary
Site 3604
Gyula, , Hungary
Site 3606
Pécs, , Hungary
Site 3613
Sopron, , Hungary
Site 3609
Szeged, , Hungary
Site 3601
Szekszárd, , Hungary
Site 3611
Szentes, , Hungary
Site 3608
Tatabánya, , Hungary
Site 3603
Vác, , Hungary
Site 3605
Zalaegerszeg, , Hungary
Site 3702
Daugavpils, , Latvia
Site 3701
Riga, , Latvia
Site 3703
Riga, , Latvia
Site 3704
Riga, , Latvia
Site 3705
Riga, , Latvia
Site 4808
Bialystok, , Poland
Site 4809
Gdansk, , Poland
Site 4810
Gdansk, , Poland
Site 4805
Katowice, , Poland
Site 4811
Lodz, , Poland
Site 4807
Poznan, , Poland
Site 4814
Poznan, , Poland
Site 4802
Skierniewice, , Poland
Site 4804
Sopot, , Poland
Site 4801
Warsaw, , Poland
Site 4806
Warsaw, , Poland
Site 4812
Wroclaw, , Poland
Site 4813
Wroclaw, , Poland
Site 0901
Moscow, , Russia
Site 0904
Moscow, , Russia
Site 0908
Moscow, , Russia
Site 0909
Moscow, , Russia
Site 0910
Moscow, , Russia
Site 4602
Gothenburg, , Sweden
Site 4603
Stockholm, , Sweden
Site 4601
Umeå, , Sweden
Countries
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Other Identifiers
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2007-000375-42
Identifier Type: -
Identifier Source: secondary_id
S339.2.001
Identifier Type: -
Identifier Source: org_study_id
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