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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
56

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 22, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 6, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 6, 2009

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2009

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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