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:
Information provided by:
Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00630279
First received: February 22, 2008
Last updated: August 4, 2009
Last verified: August 2009
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ 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 ]

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

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00630279

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

No publications provided

Responsible Party: Veronika von Hahn, Solvay Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00630279     History of Changes
Other Study ID Numbers: S339.2.001, 2007-000375-42
Study First Received: February 22, 2008
Last Updated: August 4, 2009
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 09, 2014