Pancreatic Exocrine Insufficiency Due to Chronic PancreatitisPhase 2NCT00630279
Dose-ranging Study to Evaluate Efficacy of SLV339 in Pancreatic Exocrine Insufficiency Due to Chronic Pancreatitis
A Phase 2 study testing Recombinant Microbial Lipase SLV339 in people with Pancreatic Exocrine Insufficiency Due to Chronic Pancreatitis, run by Solvay Pharmaceuticals at 50 sites in 7 countries.
Trial summary
This study is to estimate the efficacy of a number of doses in patients with pancreatic insufficiency Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Exocrine Insufficiency Due to Chronic Pancreatitis
- What is being tested?
- Recombinant Microbial Lipase SLV339
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 50 sitesin 7 countries
- Study dates
- Feb 2008to Mar 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
50 sites in 7 countries.
50 sites in 7 countries
Hungary15 sites
Site 3612
Békéscsaba
Site 3607
Budapest
Site 3614
Budapest
Site 3615
Debrecen
Site 3602
Dunaújváros
Site 3610
Eger
Site 3604
Gyula
Site 3606
Pécs
Site 3613
Sopron
Site 3609
Szeged
Site 3601
Szekszárd
Site 3611
Szentes
Site 3608
Tatabánya
Site 3603
Vác
Site 3605
Zalaegerszeg
Poland13 sites
Site 4808
Bialystok
Site 4809
Gdansk
Site 4810
Gdansk
Site 4805
Katowice
Site 4811
Lodz
Site 4807
Poznan
Site 4814
Poznan
Site 4802
Skierniewice
Site 4804
Sopot
Site 4801
Warsaw
Site 4806
Warsaw
Site 4812
Wroclaw
Site 4813
Wroclaw
Czechia6 sites
Site 4206
Brno
Site 4203
Hradec Králové
Site 4202
Prague
Site 4205
Prague
Site 4201
Tábor
Site 4204
Ústí nad Orlicí
Latvia5 sites
Site 3702
Daugavpils
Site 3701
Riga
Site 3703
Riga
Site 3704
Riga
Site 3705
Riga
Russia5 sites
Site 0901
Moscow
Site 0904
Moscow
Site 0908
Moscow
Site 0909
Moscow
Site 0910
Moscow
About this study
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
This study is to estimate the efficacy of a number of doses in patients with pancreatic insufficiency
- Being tested
- Placebo, Recombinant Microbial Lipase SLV339
- Keywords
- pancreatic exocrine insufficiency, chronic pancreatitis
- Medical subject headings
- Exocrine Pancreatic Insufficiency, Pancreatitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo
Recombinant Microbial Lipase SLV339Drug
oral, 150 mg/d, 7 days treatment
Recombinant Microbial Lipase SLV339Drug
oral, 300 mg/d, 7 days treatment
Recombinant Microbial Lipase SLV339Drug
oral, 600 mg/d, 7 days treatment
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Not described Receives: Drug: Placebo |
| 2 | Experimental | Not described Receives: Drug: Recombinant Microbial Lipase SLV339 |
| 3 | Experimental | Not described Receives: Drug: Recombinant Microbial Lipase SLV339 |
| 4 | Experimental | Not described Receives: Drug: Recombinant Microbial Lipase SLV339 |
What is being measured
The primary outcome is the main question the study is designed to answer.
CFA (Coefficient of Fat Absorption)
Measured: from baseline to end of 7 days treatment
Secondary outcomes (1)
CNA, stool fat, stool weight, nutritional parameters, clinical symptomatology
Measured: from baseline to end of 7 days treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2008 (estimated)
- Study startFeb 2008
- Primary completionMar 2009
- Study completionMar 2009
Why it stopped: This trial discontinued March 7,2009 due to high screen failure rate.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Exocrine Insufficiency Due to Chronic PancreatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Solvay Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Global Clinical Director Solvay, Study director, Solvay Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00630279
- Sponsor's protocol ID
- S339.2.001
- Other IDs
- 2007-000375-42
- Status last verified
- Aug 2009
- First submitted
- 22 Feb 2008
- Last updated
- 6 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00630279
- Acronym / sponsor ID
- S339.2.001
- Keywords
- pancreatic exocrine insufficiency, chronic pancreatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This trial discontinued March 7,2009 due to high screen failure rate.
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Solvay PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 6 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to estimate the efficacy of a number of doses in patients with pancreatic insufficiency
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: Placebo |
| 2 | Experimental | Drug: Recombinant Microbial Lipase SLV339 |
| 3 | Experimental | Drug: Recombinant Microbial Lipase SLV339 |
| 4 | Experimental | Drug: Recombinant Microbial Lipase SLV339 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPlacebo | Drug | 1 |
| Recombinant Microbial Lipase SLV339oral, 150 mg/d, 7 days treatment | Drug | 2 |
| Recombinant Microbial Lipase SLV339oral, 300 mg/d, 7 days treatment | Drug | 3 |
| Recombinant Microbial Lipase SLV339oral, 600 mg/d, 7 days treatment | Drug | 4 |
Primary outcome
CFA (Coefficient of Fat Absorption)
Time frame: from baseline to end of 7 days treatment
1 secondary outcome
CNA, stool fat, stool weight, nutritional parameters, clinical symptomatology
Time frame: from baseline to end of 7 days treatment
Results and safety
The study was stopped early (reason given: This trial discontinued March 7,2009 due to high screen failure rate.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2009.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Director Solvay study director
Solvay Pharmaceuticals
50 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Recombinant Microbial Lipase SLV339 in people with Pancreatic Exocrine Insufficiency Due to Chronic Pancreatitis, run by Solvay Pharmaceuticals at 50 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in Hungary, Poland, Czechia, Latvia, Russia and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: This trial discontinued March 7,2009 due to high screen failure rate.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CFA (Coefficient of Fat Absorption) (time frame: from baseline to end of 7 days treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2009.