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

August 4, 2009 updated by: Solvay Pharmaceuticals

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Brno, Czech Republic
        • Site 4206
      • Hradec Kralove, Czech Republic
        • Site 4203
      • Praha, Czech Republic
        • Site 4205
      • Praha 8, Czech Republic
        • Site 4202
      • Tabor, Czech Republic
        • Site 4201
      • Usti nad Orlici, Czech Republic
        • Site 4204
  • Denmark
      • Herning, Denmark
        • Site 4503
      • Hvidovre, Denmark
        • Site 4502
      • Odense, Denmark
        • Site 4501
  • Hungary
      • Bekescsaba, Hungary
        • Site 3612
      • Budapest, Hungary
        • Site 3607
      • Budapest, Hungary
        • Site 3614
      • Debrecen, Hungary
        • Site 3615
      • Dunaujvaros, Hungary
        • Site 3602
      • Eger, Hungary
        • Site 3610
      • Gyula, Hungary
        • Site 3604
      • Pecs, Hungary
        • Site 3606
      • Sopron, Hungary
        • Site 3613
      • Szeged, Hungary
        • Site 3609
      • Szekszard, Hungary
        • Site 3601
      • Szentes, Hungary
        • Site 3611
      • Tatabanya, Hungary
        • Site 3608
      • Vac, Hungary
        • Site 3603
      • Zalaegerszeg, Hungary
        • Site 3605
  • Latvia
      • Daugavpils, Latvia
        • Site 3702
      • Riga, Latvia
        • Site 3701
      • Riga, Latvia
        • Site 3703
      • Riga, Latvia
        • Site 3704
      • Riga, Latvia
        • Site 3705
  • Poland
      • Bialystok, Poland
        • Site 4808
      • Gdansk, Poland
        • Site 4809
      • Gdansk, Poland
        • Site 4810
      • Katowice, Poland
        • Site 4805
      • Lodz, Poland
        • Site 4811
      • Poznan, Poland
        • Site 4807
      • Poznan, Poland
        • Site 4814
      • Skierniewice, Poland
        • Site 4802
      • Sopot, Poland
        • Site 4804
      • Warszawa, Poland
        • Site 4801
      • Warszawa, Poland
        • Site 4806
      • Wroclaw, Poland
        • Site 4812
      • Wroclaw, Poland
        • Site 4813
  • Russian Federation
      • Moscow, Russian Federation
        • Site 0901
      • Moscow, Russian Federation
        • Site 0904
      • Moscow, Russian Federation
        • Site 0908
      • Moscow, Russian Federation
        • Site 0909
      • Moscow, Russian Federation
        • Site 0910
  • Sweden
      • Göteborg, Sweden
        • Site 4602
      • Stockholm, Sweden
        • Site 4603
      • Umea, Sweden
        • Site 4601

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 2
Drug: Recombinant Microbial Lipase SLV339
oral, 150 mg/d, 7 days treatment
Drug: Recombinant Microbial Lipase SLV339
oral, 300 mg/d, 7 days treatment
Drug: Recombinant Microbial Lipase SLV339
oral, 600 mg/d, 7 days treatment
Placebo Comparator: 1
Drug: Placebo
Placebo
Experimental: 3
Drug: Recombinant Microbial Lipase SLV339
oral, 150 mg/d, 7 days treatment
Drug: Recombinant Microbial Lipase SLV339
oral, 300 mg/d, 7 days treatment
Drug: Recombinant Microbial Lipase SLV339
oral, 600 mg/d, 7 days treatment
Experimental: 4
Drug: Recombinant Microbial Lipase SLV339
oral, 150 mg/d, 7 days treatment
Drug: Recombinant Microbial Lipase SLV339
oral, 300 mg/d, 7 days treatment
Drug: Recombinant Microbial Lipase SLV339
oral, 600 mg/d, 7 days treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
CFA (Coefficient of Fat Absorption)
Time Frame: from baseline to end of 7 days treatment
from baseline to end of 7 days treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
CNA, stool fat, stool weight, nutritional parameters, clinical symptomatology
Time Frame: from baseline to end of 7 days treatment
from baseline to end of 7 days treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Solvay Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

February 22, 2008

First Submitted That Met QC Criteria

February 26, 2008

First Posted (Estimate)

March 6, 2008

Study Record Updates

Last Update Posted (Estimate)

August 6, 2009

Last Update Submitted That Met QC Criteria

August 4, 2009

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S339.2.001
  • 2007-000375-42

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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