Exocrine Pancreatic Insufficiency in Subjects With Cystic FibrosisPhase 2NCT02415959
Efficacy and Safety Study of Creon IR in Subjects With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis
A Phase 2 study testing Creon IR and Creon® (DR/GR) in people with Exocrine Pancreatic Insufficiency in Subjects With Cystic Fibrosis, run by Abbott at 17 sites in 4 countries.
Trial summary
The objective of this study is to assess the efficacy and safety of different doses of Creon Immediate Release (IR) in comparison to Creon® 25,000 Delayed Release/Gastro-Resistant (DR/GR) in subjects with Pancreatic Exocrine Insufficiency (PEI) due to Cystis Fibrosis (CF). Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Exocrine Pancreatic Insufficiency in Subjects With Cystic Fibrosis
- What is being tested?
- Creon IR and Creon® (DR/GR)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 17 sitesin 4 countries
- Study dates
- Mar 2015to Jul 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subject has voluntarily signed and dated the Informed Consent Form (ICF). For subjects aged less than 18 years, the parents, or a legally acceptable representative, must sign consent and, as required by the Independent Ethics Committee (IEC), assent will be given by the subject.
- Subject is 12 years old or older at the time of consent signature.
- Subject has a diagnosis of CF previously confirmed by:
- a sweat chloride test > or equal to 60 mmol/Ls and/or
- two CF causing Cystic Fibrosis trans membrane conductance regulator (CFTR) mutations and
- CF clinical features
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- Subject has a documented clinically confirmed diagnosis of pancreatic exocrine insufficiency.
- Subject has human fecal elastase < 100 µg/g stool at screening
- Subject has PEI that is currently clinically controlled (no clinically overt steatorrhea or diarrhea) under treatment with a commercially available Pancreatic enzyme Replacement Therapy (PERT), on an individually established dose regimen for more than 3 months, with a daily dose not exceeding 10,000 U lipase/kg/day.
- Females of child-bearing potential and sexually active with men should agree to continue using a medically acceptable method of birth control throughout the study and for 7 days immediately after the last dose of study drug. Medically acceptable methods of birth control include bilateral tubal ligation or the use of either a contraceptive implant, a contraceptive injection (e.g., Depo Provera™), an intrauterine device, or an oral contraceptive taken continually within the past three months and which the subject agrees to continue using during the study or to adopt another birth control method, or a double-barrier method which consists of a combination of any two of the following: diaphragm, cervical cap, condom, or spermicide.
Who cannot join
- Subject is < 18 years of age and has a Body Mass Index (BMI) Z-Score below -1.5 (minus 1.5)
- Subject has a history of any of the following gastrointestinal disorders:
- pancreatitis within 6 months prior to study entry;
- fibrosing colonopathy;
- distal ileal obstruction syndrome (DIOS) within 6 months prior to study entry;
- celiac disease;
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- gastric bypass or partial/total gastrectomy;
- Crohn's disease;
- small bowel surgery (other than minor resection due to meconium ileus without resulting in malabsorption syndrome).
- Any type of malignancy involving the digestive tract in the last 5 years.
- Subjects with diabetes mellitus, for which the study specific dietary requirements may not be appropriate.
- Subject has a history of other endocrine or respiratory (except mild asthma) medical illness non-related to CF, which might limit participation in or completion of the study.
- Subject has a history of any clinically significant neurological, cardiac, renal, hepatic (including Hepatitis B or C), hematologic or psychiatric disease or disorder, or any other uncontrolled medical illness (except cystic fibrosis) which might limit participation in or completion of the study.
- Subjects requiring concomitant treatment with any medication not allowed by the protocol or is expected to be needed.
- Subjects requiring Naso-gastric, G-tubes or J-tubes.
- Subject is currently participating in any other interventional clinical study or has taken any experimental drug within 30 days prior to Screening.
- Subject is known to be HIV-positive.
- Subject has a history of allergic reaction or significant sensitivity to pancreatin or inactive ingredients (excipients) of Creon® (DR/GR) or Creon IR
Trial locations and contacts
17 sites in 4 countries.
17 sites in 4 countries
Spain6 sites
Hospital Vall d ´Hebron
Barcelona, 08035
Hospital Universitario de La Princesa
Madrid, 28006
Hospital Universitario La Paz
Madrid, 28046
Hospital Carlos Haya, Hospital Civil, Secretaria de Endocrinologia
Málaga, 29009
Hospital Universitario Virgen del Rocío, Hospital de la Mujer
Seville, 41013
Hospital La Fé Valencia
Valencia, 46026
Poland5 sites
Centrum Medyczne Karpacz S.A.
Karpacz, 58-540
Wojewódzki Szpital Specjalistyczny Im M Kopernika W Łodzi
Lodz, 93-513
Janusz Stankiewicz Sanatorium ""Cassia-Villa Medica
Rabka-Zdrój, 34-700
Podkarpacki Ośrodek Pulmonologii i Alergologii
Rzeszów, 35-612
ENEL-MED Szpital Centrum
Warsaw, 01-195
Hungary4 sites
Magyar Imre Kórház
Ajka, 8400
Kenézy Gyula Kórház
Debrecen, 4031
Kaposi Mór Oktató Kórház
Kaposvár, 7400
Tüdőgyógyintézet Törökbálint
Törökbálint, 2045
Czechia2 sites
Dětská nemocnice FN Brno, Centrum pro cystickou fibrozu
Brno, 61300
Klinika nemocí plicních a TBC
Brno, 62500
About this study
Official title: A Phase II, Multicenter, Parallel-Group, Active-Controlled, Randomized, Double-blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Different Doses of Creon IR in Subjects With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis
The objective of this study is to assess the efficacy and safety of different doses of Creon Immediate Release (IR) in comparison to Creon® 25,000 Delayed Release/Gastro-Resistant (DR/GR) in subjects with Pancreatic Exocrine Insufficiency (PEI) due to Cystis Fibrosis (CF).
Read the detailed description
This study is a Phase II, randomized, parallel-group, active-controlled, double-blind, dose ranging, multicenter study with 4 different doses of Creon IR and one dose of the active control Creon® (DR/GR), administered in subjects of 12 years or older with PEI due to CF.
The study is divided into two periods: a screening period of 14 days and a double-blind treatment period of 6 to 7 days.
- Being tested
- Creon IR, Creon® (DR/GR)
- Keywords
- Exocrine Pancreatic Insufficiency
- Medical subject headings
- Exocrine Pancreatic Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Creon IRDrug
Creon® (DR/GR)Drug
| Study group | Role | What they receive |
|---|---|---|
| Creon IR low dose | Experimental | Creon IR 300 Ph. Eur. U lipase/g fat/day, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 30,000 lipase units) Receives: Drug: Creon IR |
| Creon IR medium dose | Experimental | Creon IR 1,200 Ph. Eur. U lipase/g fat/day, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 120,000 lipase units) Receives: Drug: Creon IR |
| Creon IR high dose | Experimental | Creon IR 2,400 Ph. Eur. U lipase/g fat/day, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 240,000 lipase units) Receives: Drug: Creon IR |
| Creon IR maximum dose | Experimental | Creon IR 4,000 Ph. Eur. U lipase/g fat/day, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 400,000 lipase units) Receives: Drug: Creon IR |
| Creon® (DR/GR) | Active comparator | Creon® (DR/GR) 4,000 Ph. Eur. U lipase/g fat/day, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 400,000 lipase units) Receives: Drug: Creon® (DR/GR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coefficient of Fat Absorption (CFA)
CFA is calculated from fat intake and fat excretion, according to the formula: CFA (%) = 100 [fat intake - fat excretion] / fat intake
Measured: End of the 6 to 7 days double-blind treatment period
Secondary outcomes (3)
Coefficient of Nitrogen Absorption (CNA)
CNA is calculated from nitrogen intake and nitrogen excretion, according to the formula: CNA (%) = 100 [nitrogen intake - nitrogen excretion] / nitrogen intake)
Measured: End of the 6 to 7 days double-blind treatment period
Stool Fat Content
Total amount of fat excreted during the stool collection period in grams.
Measured: End of the 6 to 7 days double-blind treatment period
Stool Weight
Total amount of stool weight during the collection period in grams
Measured: End of the 6 to 7 days double-blind treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2015 (estimated)
- Study startMar 2015
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Exocrine Pancreatic Insufficiency in Subjects With Cystic FibrosisStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AbbVie, LKF Laboratorium für Klinische Forschung GmbH, Analytical Biochemical Laboratory, Parexel, Datamap, Linical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Suntje Sander-Struckmeier, PhD, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02415959
- Sponsor's protocol ID
- PANC2002
- Other IDs
- 2014-004519-35, 2014
- Status last verified
- Mar 2016
- First submitted
- 19 Mar 2015
- Last updated
- 4 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multicenter, Parallel-Group, Active-Controlled, Randomized, Double-blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Different Doses of Creon IR in Subjects With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT02415959
- Acronym / sponsor ID
- PANC2002
- Keywords
- Exocrine Pancreatic Insufficiency
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Collaborators
- AbbVie, LKF Laboratorium für Klinische Forschung GmbH, Analytical Biochemical Laboratory, Parexel, Datamap, Linical Co., Ltd.
- Study start
- Mar 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 14 Apr 2015 (estimated)
- Results
- Posted 17 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to assess the efficacy and safety of different doses of Creon Immediate Release (IR) in comparison to Creon® 25,000 Delayed Release/Gastro-Resistant (DR/GR) in subjects with Pancreatic Exocrine Insufficiency (PEI) due to Cystis Fibrosis (CF).
Detailed description
This study is a Phase II, randomized, parallel-group, active-controlled, double-blind, dose ranging, multicenter study with 4 different doses of Creon IR and one dose of the active control Creon® (DR/GR), administered in subjects of 12 years or older with PEI due to CF.
The study is divided into two periods: a screening period of 14 days and a double-blind treatment period of 6 to 7 days.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Creon IR low dose | Experimental | Drug: Creon IRCreon IR 300 Ph. Eur. U lipase/g fat/day, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 30,000 lipase units) |
| Creon IR medium dose | Experimental | Drug: Creon IRCreon IR 1,200 Ph. Eur. U lipase/g fat/day, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 120,000 lipase units) |
| Creon IR high dose | Experimental | Drug: Creon IRCreon IR 2,400 Ph. Eur. U lipase/g fat/day, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 240,000 lipase units) |
| Creon IR maximum dose | Experimental | Drug: Creon IRCreon IR 4,000 Ph. Eur. U lipase/g fat/day, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 400,000 lipase units) |
| Creon® (DR/GR) | Active comparator | Drug: Creon® (DR/GR)Creon® (DR/GR) 4,000 Ph. Eur. U lipase/g fat/day, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 400,000 lipase units) |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Subject has voluntarily signed and dated the Informed Consent Form (ICF). For subjects aged less than 18 years, the parents, or a legally acceptable representative, must sign consent and, as required by the Independent Ethics Committee (IEC), assent will be given by the subject.
- Subject is 12 years old or older at the time of consent signature.
- Subject has a diagnosis of CF previously confirmed by:
- Subject has a documented clinically confirmed diagnosis of pancreatic exocrine insufficiency.
- Subject has human fecal elastase < 100 µg/g stool at screening
Key exclusion criteria (18 listed)
- Subject is < 18 years of age and has a Body Mass Index (BMI) Z-Score below -1.5 (minus 1.5)
- Subject has a history of any of the following gastrointestinal disorders:
- Subjects with diabetes mellitus, for which the study specific dietary requirements may not be appropriate.
- Subject has a history of other endocrine or respiratory (except mild asthma) medical illness non-related to CF, which might limit participation in or completion of the study.
- Subject has a history of any clinically significant neurological, cardiac, renal, hepatic (including Hepatitis B or C), hematologic or psychiatric disease or disorder, or any other uncontrolled medical illness (except cystic fibrosis) which might limit participation in or completion of the study.
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 |
|---|---|---|
| Creon IR | Drug | Creon IR high dose, Creon IR low dose, Creon IR maximum dose, Creon IR medium dose |
| Creon® (DR/GR) | Drug | Creon® (DR/GR) |
Primary outcome
Coefficient of Fat Absorption (CFA)
Time frame: End of the 6 to 7 days double-blind treatment period
CFA is calculated from fat intake and fat excretion, according to the formula: CFA (%) = 100 [fat intake - fat excretion] / fat intake
3 secondary outcomes
Coefficient of Nitrogen Absorption (CNA)
Time frame: End of the 6 to 7 days double-blind treatment period
Stool Fat Content
Time frame: End of the 6 to 7 days double-blind treatment period
Stool Weight
Time frame: End of the 6 to 7 days double-blind treatment period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Exocrine Pancreatic Insufficiency (EPI), Cystic Fibrosis (CF)
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.
Suntje Sander-Struckmeier, PhD study director
Abbott
17 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Creon IR and Creon® (DR/GR) in people with Exocrine Pancreatic Insufficiency in Subjects With Cystic Fibrosis, run by Abbott at 17 sites in 4 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 10 inclusion and 18 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: finished, as of the sponsor's last update on 4 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Spain, Poland, Hungary, Czechia. 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. 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?
Yes. Results are posted in the registry (first posted 17 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Coefficient of Fat Absorption (CFA) (time frame: End of the 6 to 7 days double-blind treatment period). 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 4 Apr 2016.