Clinical trial NCT00630279: Dose-ranging Study to Evaluate Efficacy of SLV339 in Pancreatic Exocrine Insufficiency Due to Chronic Pancreatitis
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Pancreatic Exocrine Insufficiency Due to Chronic Pancreatitis
Keywords: pancreatic exocrine insufficiency
chronic pancreatitis
Lead sponsor: Solvay Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2008-03-06
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: CFA (Coefficient of Fat Absorption)
timeFrame: from baseline to end of 7 days treatment
Secondary outcomes:
measure: CNA, stool fat, stool weight, nutritional parameters, clinical symptomatology
timeFrame: from baseline to end of 7 days treatment
Other outcomes:
Locations:
city: Brno
country: Czech Republic
facility: Site 4206
city: Hradec Kralove
country: Czech Republic
facility: Site 4203
city: Praha 8
country: Czech Republic
facility: Site 4202
city: Praha
country: Czech Republic
facility: Site 4205
city: Tabor
country: Czech Republic
facility: Site 4201
city: Usti nad Orlici
country: Czech Republic
facility: Site 4204
city: Herning
country: Denmark
facility: Site 4503
city: Hvidovre
country: Denmark
facility: Site 4502
city: Odense
country: Denmark
facility: Site 4501
city: Bekescsaba
country: Hungary
facility: Site 3612
city: Budapest
country: Hungary
facility: Site 3607
city: Budapest
country: Hungary
facility: Site 3614
city: Debrecen
country: Hungary
facility: Site 3615
city: Dunaujvaros
country: Hungary
facility: Site 3602
city: Eger
country: Hungary
facility: Site 3610
city: Gyula
country: Hungary
facility: Site 3604
city: Pecs
country: Hungary
facility: Site 3606
city: Sopron
country: Hungary
facility: Site 3613
city: Szeged
country: Hungary
facility: Site 3609
city: Szekszard
country: Hungary
facility: Site 3601
city: Szentes
country: Hungary
facility: Site 3611
city: Tatabanya
country: Hungary
facility: Site 3608
city: Vac
country: Hungary
facility: Site 3603
city: Zalaegerszeg
country: Hungary
facility: Site 3605
city: Daugavpils
country: Latvia
facility: Site 3702
city: Riga
country: Latvia
facility: Site 3701
city: Riga
country: Latvia
facility: Site 3703
city: Riga
country: Latvia
facility: Site 3704
city: Riga
country: Latvia
facility: Site 3705
city: Bialystok
country: Poland
facility: Site 4808
city: Gdansk
country: Poland
facility: Site 4809
city: Gdansk
country: Poland
facility: Site 4810
city: Katowice
country: Poland
facility: Site 4805
city: Lodz
country: Poland
facility: Site 4811
city: Poznan
country: Poland
facility: Site 4807
city: Poznan
country: Poland
facility: Site 4814
city: Skierniewice
country: Poland
facility: Site 4802
city: Sopot
country: Poland
facility: Site 4804
city: Warszawa
country: Poland
facility: Site 4801
city: Warszawa
country: Poland
facility: Site 4806
city: Wroclaw
country: Poland
facility: Site 4812
city: Wroclaw
country: Poland
facility: Site 4813
city: Moscow
country: Russian Federation
facility: Site 0901
city: Moscow
country: Russian Federation
facility: Site 0904
city: Moscow
country: Russian Federation
facility: Site 0908
city: Moscow
country: Russian Federation
facility: Site 0909
city: Moscow
country: Russian Federation
facility: Site 0910
city: Göteborg
country: Sweden
facility: Site 4602
city: Stockholm
country: Sweden
facility: Site 4603
city: Umea
country: Sweden
facility: Site 4601
Study officials:
affiliation: Solvay Pharmaceuticals
name: Global Clinical Director Solvay
role: STUDY_DIRECTOR
References: