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

March 7, 2016 updated by: Abbott

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).

Study Overview

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

Enrollment (Actual)

70

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Brno, Czech Republic, 61300
        • Dětská nemocnice FN Brno, Centrum pro cystickou fibrozu
      • Brno, Czech Republic, 62500
        • Klinika nemocí plicních a TBC
      • Ajka, Hungary, 8400
        • Magyar Imre Kórház
      • Debrecen, Hungary, 4031
        • Kenezy Gyula Korhaz
      • Kaposvár, Hungary, 7400
        • Kaposi Mór Oktató Kórház
      • Törökbálint, Hungary, 2045
        • Tüdőgyógyintézet Törökbálint
      • Karpacz, Poland, 58-540
        • Centrum Medyczne Karpacz S.A.
      • Lodzi, Poland, 93-513
        • Wojewódzki Szpital Specjalistyczny Im M Kopernika W Łodzi
      • Rabka, Poland, 34-700
        • Janusz Stankiewicz Sanatorium ""Cassia-Villa Medica
      • Rzeszów, Poland, 35-612
        • Podkarpacki Osrodek Pulmonologii i Alergologii
      • Warszawa, Poland, 01-195
        • ENEL-MED Szpital Centrum
      • Barcelona, Spain, 08035
        • Hospital Vall d ´Hebron
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Madrid, Spain, 28006
        • Hospital Universitario de La Princesa
      • Málaga, Spain, 29009
        • Hospital Carlos Haya, Hospital Civil, Secretaria de Endocrinologia
      • Sevilla, Spain, 41013
        • Hospital Universitario Virgen del Rocio, Hospital de la Mujer
      • Valencia, Spain, 46026
        • Hospital La Fe Valencia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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)
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)
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)
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)
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
End of the 6 to 7 days double-blind treatment period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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
Total amount of fat excreted during the stool collection period in grams.
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
Total amount of stool weight during the collection period in grams
End of the 6 to 7 days double-blind treatment period

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From randomization to end of Double Blind period plus 1 day, i.e. up to 7/8 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

March 19, 2015

First Submitted That Met QC Criteria

April 9, 2015

First Posted (Estimate)

April 14, 2015

Study Record Updates

Last Update Posted (Estimate)

April 4, 2016

Last Update Submitted That Met QC Criteria

March 7, 2016

Last Verified

March 1, 2016

More Information

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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