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Efficacy and Safety Study of Creon IR in Subjects With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis

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ClinicalTrials.gov Identifier: NCT02415959
Recruitment Status : Completed
First Posted : April 14, 2015
Results First Posted : February 17, 2016
Last Update Posted : April 4, 2016
Sponsor:
Collaborators:
AbbVie
LKF Laboratorium für Klinische Forschung GmbH
Analytical Biochemical Laboratory
Parexel
Datamap
Linical Co., Ltd.
Information provided by (Responsible Party):
Abbott

Brief 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).

Condition or disease Intervention/treatment Phase
Exocrine Pancreatic Insufficiency in Subjects With Cystic Fibrosis Drug: Creon IR Drug: Creon® (DR/GR) Phase 2

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 : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
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
Study Start Date : March 2015
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arm Intervention/treatment
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)
Drug: Creon IR
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)
Drug: Creon IR
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)
Drug: Creon IR
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)
Drug: Creon IR
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)
Drug: Creon® (DR/GR)



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Coefficient of Nitrogen Absorption (CNA) [ Time Frame: End of the 6 to 7 days double-blind treatment period ]
    CNA is calculated from nitrogen intake and nitrogen excretion, according to the formula: CNA (%) = 100 [nitrogen intake - nitrogen excretion] / nitrogen intake)

  2. Stool Fat Content [ Time Frame: End of the 6 to 7 days double-blind treatment period ]
    Total amount of fat excreted during the stool collection period in grams.

  3. Stool Weight [ Time Frame: End of the 6 to 7 days double-blind treatment period ]
    Total amount of stool weight during the collection period in grams


Other Outcome Measures:
  1. Treatment Emergent Adverse Events [ Time Frame: From randomization to end of Double Blind period plus 1 day, i.e. up to 7/8 days ]
    Treatment emergent adverse events will be summarized per treatment group



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. Subject is 12 years old or older at the time of consent signature.
  3. 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
  4. Subject has a documented clinically confirmed diagnosis of pancreatic exocrine insufficiency.
  5. Subject has human fecal elastase < 100 µg/g stool at screening
  6. 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.
  7. 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:

  1. Subject is < 18 years of age and has a Body Mass Index (BMI) Z-Score below -1.5 (minus 1.5)
  2. 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.
  3. Subjects with diabetes mellitus, for which the study specific dietary requirements may not be appropriate.
  4. 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.
  5. 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.
  6. Subjects requiring concomitant treatment with any medication not allowed by the protocol or is expected to be needed.
  7. Subjects requiring Naso-gastric, G-tubes or J-tubes.
  8. Subject is currently participating in any other interventional clinical study or has taken any experimental drug within 30 days prior to Screening.
  9. Subject is known to be HIV-positive.
  10. Subject has a history of allergic reaction or significant sensitivity to pancreatin or inactive ingredients (excipients) of Creon® (DR/GR) or Creon IR

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02415959


Locations
Czech Republic
Dětská nemocnice FN Brno, Centrum pro cystickou fibrozu
Brno, Czech Republic, 61300
Klinika nemocí plicních a TBC
Brno, Czech Republic, 62500
Hungary
Magyar Imre Kórház
Ajka, Hungary, 8400
Kenézy Gyula Kórház
Debrecen, Hungary, 4031
Kaposi Mór Oktató Kórház
Kaposvár, Hungary, 7400
Tüdőgyógyintézet Törökbálint
Törökbálint, Hungary, 2045
Poland
Centrum Medyczne Karpacz S.A.
Karpacz, Poland, 58-540
Wojewódzki Szpital Specjalistyczny Im M Kopernika W Łodzi
Lodzi, Poland, 93-513
Janusz Stankiewicz Sanatorium ""Cassia-Villa Medica
Rabka, Poland, 34-700
Podkarpacki Ośrodek Pulmonologii i Alergologii
Rzeszów, Poland, 35-612
ENEL-MED Szpital Centrum
Warszawa, Poland, 01-195
Spain
Hospital Vall d ´Hebron
Barcelona, Spain, 08035
Hospital Universitario de La Princesa
Madrid, Spain, 28006
Hospital Universitario La Paz
Madrid, Spain, 28046
Hospital Carlos Haya, Hospital Civil, Secretaria de Endocrinologia
Málaga, Spain, 29009
Hospital Universitario Virgen del Rocío, Hospital de la Mujer
Sevilla, Spain, 41013
Hospital La Fé Valencia
Valencia, Spain, 46026
Sponsors and Collaborators
Abbott
AbbVie
LKF Laboratorium für Klinische Forschung GmbH
Analytical Biochemical Laboratory
Parexel
Datamap
Linical Co., Ltd.
Investigators
Study Director: Suntje Sander-Struckmeier, PhD Abbott

Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT02415959     History of Changes
Other Study ID Numbers: PANC2002
2014-004519-35 ( EudraCT Number )
First Posted: April 14, 2015    Key Record Dates
Results First Posted: February 17, 2016
Last Update Posted: April 4, 2016
Last Verified: March 2016

Keywords provided by Abbott:
Exocrine Pancreatic Insufficiency

Additional relevant MeSH terms:
Fibrosis
Cystic Fibrosis
Exocrine Pancreatic Insufficiency
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pancrelipase
Pancreatin
Gastrointestinal Agents