Pancreatic Exocrine Insufficiency Due to Chronic Pancreatitis Clinical Trial
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
| Verified date | August 2009 |
| Source | Solvay Pharmaceuticals |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
This study is to estimate the efficacy of a number of doses in patients with pancreatic insufficiency
| Status | Terminated |
| Enrollment | 56 |
| Est. completion date | March 2009 |
| Est. primary completion date | March 2009 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Czech Republic | Site 4206 | Brno | |
| Czech Republic | Site 4203 | Hradec Kralove | |
| Czech Republic | Site 4205 | Praha | |
| Czech Republic | Site 4202 | Praha 8 | |
| Czech Republic | Site 4201 | Tabor | |
| Czech Republic | Site 4204 | Usti nad Orlici | |
| Denmark | Site 4503 | Herning | |
| Denmark | Site 4502 | Hvidovre | |
| Denmark | Site 4501 | Odense | |
| Hungary | Site 3612 | Bekescsaba | |
| Hungary | Site 3607 | Budapest | |
| Hungary | Site 3614 | Budapest | |
| Hungary | Site 3615 | Debrecen | |
| Hungary | Site 3602 | Dunaujvaros | |
| Hungary | Site 3610 | Eger | |
| Hungary | Site 3604 | Gyula | |
| Hungary | Site 3606 | Pecs | |
| Hungary | Site 3613 | Sopron | |
| Hungary | Site 3609 | Szeged | |
| Hungary | Site 3601 | Szekszard | |
| Hungary | Site 3611 | Szentes | |
| Hungary | Site 3608 | Tatabanya | |
| Hungary | Site 3603 | Vac | |
| Hungary | Site 3605 | Zalaegerszeg | |
| Latvia | Site 3702 | Daugavpils | |
| Latvia | Site 3701 | Riga | |
| Latvia | Site 3703 | Riga | |
| Latvia | Site 3704 | Riga | |
| Latvia | Site 3705 | Riga | |
| Poland | 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 | Warszawa | |
| Poland | Site 4806 | Warszawa | |
| Poland | Site 4812 | Wroclaw | |
| Poland | Site 4813 | Wroclaw | |
| Russian Federation | Site 0901 | Moscow | |
| Russian Federation | Site 0904 | Moscow | |
| Russian Federation | Site 0908 | Moscow | |
| Russian Federation | Site 0909 | Moscow | |
| Russian Federation | Site 0910 | Moscow | |
| Sweden | Site 4602 | Göteborg | |
| Sweden | Site 4603 | Stockholm | |
| Sweden | Site 4601 | Umea |
| Lead Sponsor | Collaborator |
|---|---|
| Solvay Pharmaceuticals |
Czech Republic, Denmark, Hungary, Latvia, Poland, Russian Federation, Sweden,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | CFA (Coefficient of Fat Absorption) | from baseline to end of 7 days treatment | No | |
| Secondary | CNA, stool fat, stool weight, nutritional parameters, clinical symptomatology | from baseline to end of 7 days treatment | No |