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Dose-ranging Study to Evaluate Efficacy of SLV339 in Pancreatic Exocrine Insufficiency Due to Chronic Pancreatitis

This study has been terminated.
(This trial discontinued March 7,2009 due to high screen failure rate.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00630279
First Posted: March 6, 2008
Last Update Posted: August 6, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Solvay Pharmaceuticals
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


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 ]

Secondary Outcome Measures:
  • CNA, stool fat, stool weight, nutritional parameters, clinical symptomatology [ Time Frame: from baseline to end of 7 days treatment ]

Enrollment: 56
Study Start Date: February 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1 Drug: Placebo
Placebo
Experimental: 2 Drug: Recombinant Microbial Lipase SLV339
oral, 150 mg/d, 7 days treatment
Experimental: 3 Drug: Recombinant Microbial Lipase SLV339
oral, 300 mg/d, 7 days treatment
Experimental: 4 Drug: Recombinant Microbial Lipase SLV339
oral, 600 mg/d, 7 days treatment

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00630279


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

Responsible Party: Veronika von Hahn, Solvay Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00630279     History of Changes
Other Study ID Numbers: S339.2.001
2007-000375-42
First Submitted: February 22, 2008
First Posted: March 6, 2008
Last Update Posted: August 6, 2009
Last Verified: August 2009

Keywords provided by Solvay Pharmaceuticals:
pancreatic exocrine insufficiency
chronic pancreatitis

Additional relevant MeSH terms:
Pancreatitis
Pancreatitis, Chronic
Exocrine Pancreatic Insufficiency
Pancreatic Diseases
Digestive System Diseases