Study Stopped
This trial discontinued March 7,2009 due to high screen failure rate.
Dose-ranging Study to Evaluate Efficacy of SLV339 in Pancreatic Exocrine Insufficiency Due to Chronic Pancreatitis
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
2 other identifiers
interventional
56
7 countries
50
Brief Summary
This study is to estimate the efficacy of a number of doses in patients with pancreatic insufficiency
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Feb 2008
Shorter than P25 for phase_2
50 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 22, 2008
CompletedFirst Posted
Study publicly available on registry
March 6, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedAugust 6, 2009
August 1, 2009
1.1 years
February 22, 2008
August 4, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
CFA (Coefficient of Fat Absorption)
from baseline to end of 7 days treatment
Secondary Outcomes (1)
CNA, stool fat, stool weight, nutritional parameters, clinical symptomatology
from baseline to end of 7 days treatment
Study Arms (4)
1
PLACEBO COMPARATOR2
EXPERIMENTAL3
EXPERIMENTAL4
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (50)
Site 4206
Brno, Czechia
Site 4203
Hradec Králové, Czechia
Site 4202
Prague, Czechia
Site 4205
Prague, Czechia
Site 4201
Tábor, Czechia
Site 4204
Ústí nad Orlicí, Czechia
Site 4503
Herning, Denmark
Site 4502
Hvidovre, Denmark
Site 4501
Odense, Denmark
Site 3612
Békéscsaba, Hungary
Site 3607
Budapest, Hungary
Site 3614
Budapest, Hungary
Site 3615
Debrecen, Hungary
Site 3602
Dunaújváros, Hungary
Site 3610
Eger, Hungary
Site 3604
Gyula, Hungary
Site 3606
Pécs, Hungary
Site 3613
Sopron, Hungary
Site 3609
Szeged, Hungary
Site 3601
Szekszárd, Hungary
Site 3611
Szentes, Hungary
Site 3608
Tatabánya, Hungary
Site 3603
Vác, Hungary
Site 3605
Zalaegerszeg, Hungary
Site 3702
Daugavpils, Latvia
Site 3701
Riga, Latvia
Site 3703
Riga, Latvia
Site 3704
Riga, Latvia
Site 3705
Riga, Latvia
Site 4808
Bialystok, Poland
Site 4809
Gdansk, Poland
Site 4810
Gdansk, Poland
Site 4805
Katowice, Poland
Site 4811
Lodz, Poland
Site 4807
Poznan, Poland
Site 4814
Poznan, Poland
Site 4802
Skierniewice, Poland
Site 4804
Sopot, Poland
Site 4801
Warsaw, Poland
Site 4806
Warsaw, Poland
Site 4812
Wroclaw, Poland
Site 4813
Wroclaw, Poland
Site 0901
Moscow, Russia
Site 0904
Moscow, Russia
Site 0908
Moscow, Russia
Site 0909
Moscow, Russia
Site 0910
Moscow, Russia
Site 4602
Gothenburg, Sweden
Site 4603
Stockholm, Sweden
Site 4601
Umeå, Sweden
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Director Solvay
Solvay Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 22, 2008
First Posted
March 6, 2008
Study Start
February 1, 2008
Primary Completion
March 1, 2009
Study Completion
March 1, 2009
Last Updated
August 6, 2009
Record last verified: 2009-08