- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01641393
Safety and Efficacy Study of 2 Pancreatic Enzymes for Treatment of Exocrine Pancreatic Insufficiency in Cystic Fibrosis.
March 13, 2014 updated by: Forest Laboratories
A Randomised, Double-Blind, Active-Controlled, Two-Treatment, Crossover, Multinational, Multicentre Study to Compare Two Pancreatic Enzyme Products in the Treatment of Exocrine Pancreatic Insufficiency in Subjects With Cystic Fibrosis
The purpose of the study is to further evaluate the safety and efficacy of EUR-1008 as compared to Kreon® in the treatment of exocrine pancreatic insufficiency associated with Cystic Fibrosis in subjects 12 years of age and older.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
96
Phase
- Phase 3
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
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Antwerp, Belgium
- University Hospital Antwerp - Universitair Ziekenhuis Antwerpen (UZA)
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Gent, Belgium
- Universitair Ziekenhuis Gent, Centrum voor Mucoviscidose
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Pleven, Bulgaria
- Clinic of Paediatric Diseases at UMHAT Dr Georgi Stranski
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Plovdiv, Bulgaria
- Clinic of Genetic and Paediatric Diseases at UMHAT Sveti Georgi
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Ruse, Bulgaria
- Specialized Hospital for Active Treatment of Pulmological and Phtisiatric Disease
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Varna, Bulgaria
- Multiprofile Clinic for Specialized Pediatric Clinic at MHAT Sveta Marina
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Montpellier Cedex 5, France
- Hopital Arnaud de Villeneuve
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Strasbourg Cedex, France
- Nouvel Hopital Civil
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Bochum, Germany
- Ruhr-Universitaet Bochum - St. Josef Hospital
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Dresden, Germany
- Universitaetsklinikum Carl Gustav Carus an der TU Dresden
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Essen, Germany
- Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitaetsklinikum Essen gGmbH
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Essen, Germany
- Universitätsklinikum Essen Zentrum f.Kinderheilkunde Klinik f.Kinderheilkunde III
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Jena, Germany
- Universitatsklinikum Jena, Klinik fur Kinder und Jugendmedizin
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Muenchen, Germany
- Medizinische Klinik Innenstadt
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Tuebingen, Germany
- Universitaetsklinik für Kinder- und Jugendmedizin Tuebingen
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Ancona, Italy
- Azienda Ospedaliero Universitaria, Ospedali Riuniti, Ospedale Pediatrico G. Salesi
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Bari, Italy
- Azienda Ospedale Policlinico di Bari
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Catania, Italy
- University of Catania
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Contesse -Messina, Italy
- Azienda Ospedaliera Universitaria Policlinico G. Martino, Gastroenterologia Pediatrica E Fibrosi Cistica
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Naples, Italy
- University Federico II of Naples, Pediatrics Department
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Orbassano (Torino), Italy
- Clinica di Malattie dell'Apparato Respiratorio
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Parma, Italy
- Istituto Azienda Ospedaliera Universitaria
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Roma, Italy
- Universita degli Studi di Roma La Sapienza, Azienda Policlinico Umberto I, Dipartimento di Pediatria, Centro Fibrosi Cistica Regione Lazio
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Rome, Italy
- Bambino Gesu Hospital, Cystic Fibrosis Unit
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Turin, Italy
- Ospedale Infantile Regina Margherita
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Verona, Italy
- Azienda Ospedaliera Universitaria Integrata, Centro Fibrosi Cistica-Ospedale Civile Maggiore
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Gdansk, Poland
- Specjalistyczny Zespot Opieki Zdrowotnej nad Matka i Dzieckiem Poradnia Leczenia Mukowiscydozy
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Karpacz, Poland
- Centrum Pulmonologii i Alergologii w Karpaczu
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Lodzi, Poland
- Wojewodzki Szpital Specjalistyczny im Kopernika
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Lublin, Poland
- ALERGOTEST s.c Specjalistyczne Centrum Medyczne
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Poznan, Poland
- Szpital Kliniczny im Karola Jonschera
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Rabka Zdrój, Poland
- NZOZ Sanatorium Cassia Villa Medica
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Rzeszow, Poland
- NZOZ Podkarpacki Osrodek Pulmonologii i Alergologii
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Warszawa, Poland
- Centrum Zdrowia Matki, Dziecka i Mlodziezy
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Warszawa, Poland
- IRMED Irena Wojciechowska
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Liverpool, United Kingdom
- Liverpool Heart and Chest Hospital
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Sheffield, United Kingdom
- Sheffield Children's Hospital, The Academic Unit of Child Health
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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
12 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Definitive diagnosis of CF based on the following:
- One clinical feature consistent with CF and
- Either a genotype with 2 identifiable mutations known to cause CF or a sweat chloride concentration >60 mEq/L by pilocarpine iontophoresis
- Pancreatic insufficiency documented by a monoclonal faecal elastase (FE) 100 μg/g stool at screening (test results within the previous 12 months are acceptable)
- Currently receiving pancreatic enzyme replacement therapy
- Adequate nutritional status based on the following: body mass index (BMI) >19 kg/m2 in adult subjects or a BMI percentile 10th percentile for age in adolescent (12 to 17 years age group) subjects
- Are clinically stable with no evidence of concomitant illness or acute upper or lower respiratory tract infection that requires antibiotics during the 7-day interval prior to screening and preceding entry into this clinical study
Exclusion Criteria:
- Age <12 years
- Known contraindication, hypersensitivity, or intolerance to pork or other porcine PEPs
- Current uncontrolled diabetes mellitus
- History of solid organ transplantation
- History of surgery affecting the bowel function and weight gain
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
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: EUR-1008 then Kreon
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EUR-1008 25,000 Units is a PEP with pancreas powder as the active ingredient.18
Pancreas powder contains various enzymes having proteolytic, lipolytic, and amylolytic activity.
Each capsule contains approximately 25,000 Ph.
Eur.
lipase units.
EUR-1008 25,000 consists of orally administered capsules containing enteric-coated beads.
Other Names:
Kreon 25,000 is a PEP consisting of porcine-derived pancreatic enzymes.18
Each capsule contains approximately 25,000 Ph.
Eur.
lipase units.
Kreon 25,000 consists of orally administered capsules containing enteric-coated spheres.
Other Names:
|
Experimental: Kreon then EUR-1008
|
EUR-1008 25,000 Units is a PEP with pancreas powder as the active ingredient.18
Pancreas powder contains various enzymes having proteolytic, lipolytic, and amylolytic activity.
Each capsule contains approximately 25,000 Ph.
Eur.
lipase units.
EUR-1008 25,000 consists of orally administered capsules containing enteric-coated beads.
Other Names:
Kreon 25,000 is a PEP consisting of porcine-derived pancreatic enzymes.18
Each capsule contains approximately 25,000 Ph.
Eur.
lipase units.
Kreon 25,000 consists of orally administered capsules containing enteric-coated spheres.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Coefficient of Fat Absorption over 72 hours (CFA-72h)
Time Frame: 72 hours
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During the last 72 hours of each treatment period, the CFA-72h will be calculated using fat intake data from the diet and fat excretion data from stools.
Fat intake will be calculated by the dietician in collaboration with the study investigator using a validated tool.
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72 hours
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Body weight
Time Frame: 58 days.
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Body weight at baseline (Visit 2 [Day 0]) and at the end of each treatment period.
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58 days.
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Coefficient of nitrogen absorption
Time Frame: 72 hours
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Coefficient of nitrogen absorption at the end of each treatment period as assessed by a specialised central laboratory by means of Dumas combustion method.
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72 hours
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Control of signs and symptoms of EPI
Time Frame: 2- 14 day periods
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Control of signs and symptoms of EPI (as recorded in subject diaries). The following will be captured:
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2- 14 day periods
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Impact on overall health, daily life, perceived well-being, and symptoms
Time Frame: 58 days
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Impact on overall health, daily life, perceived well-being, and symptoms evaluated using the CFQ (administered by designated study personnel prior to randomisation and at the end of each treatment period).
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58 days
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Total cholesterol, calculated LDL-C, HDL-C
Time Frame: 58 days
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Total cholesterol, calculated LDL-C, HDL-C (sampling performed prior to randomisation and at the end of each treatment period).
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58 days
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Treatment Emergent Adverse Events
Time Frame: 78 days
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Frequency, duration, and severity of treatment-emergent adverse events (TEAEs);
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78 days
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Standard safety laboratory tests
Time Frame: 58 days
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Standard safety laboratory tests, analysed by central laboratory:
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58 days
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Vital signs
Time Frame: 78 days
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Vital signs including blood pressure, heart rate, respirations and body temperature.
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78 days
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Fat-soluble vitamins A, D, and E
Time Frame: 58 days
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Fat-soluble vitamins A, D, and E (sampling performed prior to randomisation and at the end of each treatment period).
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58 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Christopher Taylor, MD, PhD, Sheffield Children's Hospital, The Academic Unit of Child Health
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Somaraju URR, Solis-Moya A. Pancreatic enzyme replacement therapy for people with cystic fibrosis. Cochrane Database Syst Rev. 2020 Aug 5;8(8):CD008227. doi: 10.1002/14651858.CD008227.pub4.
- Taylor CJ, Thieroff-Ekerdt R, Shiff S, Magnus L, Fleming R, Gommoll C. Comparison of two pancreatic enzyme products for exocrine insufficiency in patients with cystic fibrosis. J Cyst Fibros. 2016 Sep;15(5):675-80. doi: 10.1016/j.jcf.2016.02.010. Epub 2016 Mar 21.
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
June 1, 2012
Primary Completion (Actual)
February 1, 2014
Study Completion (Actual)
February 1, 2014
Study Registration Dates
First Submitted
July 10, 2012
First Submitted That Met QC Criteria
July 12, 2012
First Posted (Estimate)
July 16, 2012
Study Record Updates
Last Update Posted (Estimate)
March 14, 2014
Last Update Submitted That Met QC Criteria
March 13, 2014
Last Verified
March 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PR-005
- 2009-012842-21 (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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First Wave Bio, Inc.CompletedCystic Fibrosis (CF) | Exocrine Pancreatic Insufficiency (EPI)United States, Poland
-
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AzurRx SASCompletedCystic Fibrosis | Cystic Fibrosis Gastrointestinal Disease | Cystic Fibrosis of PancreasTurkey, Hungary
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Changhai HospitalPeking Union Medical College Hospital; Xuanwu Hospital, BeijingCompleted
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Forest LaboratoriesCompletedCystic Fibrosis | Exocrine Pancreatic InsufficiencyUnited States