Status:
TERMINATED
Dose-ranging Study to Evaluate Efficacy of SLV339 in Pancreatic Exocrine Insufficiency Due to Chronic Pancreatitis
Lead Sponsor:
Solvay Pharmaceuticals
Conditions:
Pancreatic Exocrine Insufficiency Due to Chronic Pancreatitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study is to estimate the efficacy of a number of doses in patients with pancreatic insufficiency
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00630279
Start Date
February 1 2008
End Date
March 1 2009
Last Update
August 6 2009
Active Locations (50)
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1
Site 4206
Brno, Czechia
2
Site 4203
Hradec Králové, Czechia
3
Site 4202
Prague, Czechia
4
Site 4205
Prague, Czechia