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Dose-Ranging Study to Evaluate Efficacy of SLV339 in Pancreatic Exocrine Insufficiency Due to Chronic Pancreatitis
This study is currently recruiting participants.
Verified by Solvay Pharmaceuticals, November 2008
Sponsored by: Solvay Pharmaceuticals
Information provided by: Solvay Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00630279
  Purpose

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


Condition Intervention Phase
Pancreatic Exocrine Insufficiency Due to Chronic Pancreatitis
Drug: Placebo
Drug: Recombinant Microbial Lipase SLV339
Phase II

Drug Information available for: Lipase
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
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

Further study details as provided by Solvay Pharmaceuticals:

Primary Outcome Measures:
  • CFA (Coefficient of Fat Absorption) [ Time Frame: from baseline to end of 7 days treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • CNA, stool fat, stool weight, nutritional parameters, clinical symptomatology [ Time Frame: from baseline to end of 7 days treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: February 2008
Estimated Study Completion Date: March 2009
Estimated Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Placebo Comparator Drug: Placebo
Placebo
2: Experimental Drug: Recombinant Microbial Lipase SLV339
oral, 150 mg/d, 7 days treatment
3: Experimental Drug: Recombinant Microbial Lipase SLV339
oral, 300 mg/d, 7 days treatment
4: Experimental Drug: Recombinant Microbial Lipase SLV339
oral, 600 mg/d, 7 days treatment

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00630279

Contacts
Contact: Veronika von Hahn veronika.vonhahn@solvay.com

  Show 50 Study Locations
Sponsors and Collaborators
Solvay Pharmaceuticals
Investigators
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
  More Information

Responsible Party: Solvay Pharmaceuticals ( Veronika von Hahn )
Study ID Numbers: S339.2.001, 2007-000375-42
Study First Received: February 22, 2008
Last Updated: November 28, 2008
ClinicalTrials.gov Identifier: NCT00630279  
Health Authority: United States: Institutional Review Board

Keywords provided by Solvay Pharmaceuticals:
pancreatic exocrine insufficiency
chronic pancreatitis

Study placed in the following topic categories:
Digestive System Diseases
Pancreatic Diseases
Pancreatitis
Pancreatitis, Chronic

ClinicalTrials.gov processed this record on January 15, 2009