- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02415959
Efficacy and Safety Study of Creon IR in Subjects With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis
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
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Brno, Czech Republic, 61300
- Dětská nemocnice FN Brno, Centrum pro cystickou fibrozu
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Brno, Czech Republic, 62500
- Klinika nemocí plicních a TBC
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Ajka, Hungary, 8400
- Magyar Imre Kórház
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Debrecen, Hungary, 4031
- Kenezy Gyula Korhaz
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Kaposvár, Hungary, 7400
- Kaposi Mór Oktató Kórház
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Törökbálint, Hungary, 2045
- Tüdőgyógyintézet Törökbálint
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Karpacz, Poland, 58-540
- Centrum Medyczne Karpacz S.A.
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Lodzi, Poland, 93-513
- Wojewódzki Szpital Specjalistyczny Im M Kopernika W Łodzi
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Rabka, Poland, 34-700
- Janusz Stankiewicz Sanatorium ""Cassia-Villa Medica
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Rzeszów, Poland, 35-612
- Podkarpacki Osrodek Pulmonologii i Alergologii
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Warszawa, Poland, 01-195
- ENEL-MED Szpital Centrum
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Barcelona, Spain, 08035
- Hospital Vall d ´Hebron
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Madrid, Spain, 28046
- Hospital Universitario La Paz
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Madrid, Spain, 28006
- Hospital Universitario de La Princesa
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Málaga, Spain, 29009
- Hospital Carlos Haya, Hospital Civil, Secretaria de Endocrinologia
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Sevilla, Spain, 41013
- Hospital Universitario Virgen del Rocio, Hospital de la Mujer
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Valencia, Spain, 46026
- Hospital La Fe Valencia
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
- 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.
Exclusion Criteria:
- 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;
- 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
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Creon IR low dose
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)
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Experimental: Creon IR medium dose
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)
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Experimental: Creon IR high dose
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)
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Experimental: Creon IR maximum dose
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)
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Active Comparator: 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)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Coefficient of Fat Absorption (CFA)
Time Frame: End of the 6 to 7 days double-blind treatment period
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CFA is calculated from fat intake and fat excretion, according to the formula: CFA (%) = 100 [fat intake - fat excretion] / fat intake
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End of the 6 to 7 days double-blind treatment period
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Coefficient of Nitrogen Absorption (CNA)
Time Frame: End of the 6 to 7 days double-blind treatment period
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CNA is calculated from nitrogen intake and nitrogen excretion, according to the formula: CNA (%) = 100 [nitrogen intake - nitrogen excretion] / nitrogen intake)
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End of the 6 to 7 days double-blind treatment period
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Stool Fat Content
Time Frame: End of the 6 to 7 days double-blind treatment period
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Total amount of fat excreted during the stool collection period in grams.
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End of the 6 to 7 days double-blind treatment period
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Stool Weight
Time Frame: End of the 6 to 7 days double-blind treatment period
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Total amount of stool weight during the collection period in grams
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End of the 6 to 7 days double-blind treatment period
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Treatment Emergent Adverse Events
Time Frame: From randomization to end of Double Blind period plus 1 day, i.e. up to 7/8 days
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Treatment emergent adverse events will be summarized per treatment group
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From randomization to end of Double Blind period plus 1 day, i.e. up to 7/8 days
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PANC2002
- 2014-004519-35 (EudraCT Number)
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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