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NCT Number: NCT01641393

Safety and Efficacy Study of 2 Pancreatic Enzymes for Treatment of Exocrine Pancreatic Insufficiency in 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.

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Key information

Conditions

Exocrine Pancreatic Insufficiency: Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cystic Fibrosis Digestive System Diseases Exocrine Pancreatic Insufficiency Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University Hospital Antwerp - Universitair Ziekenhuis Antwerpen (UZA), Antwerp, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EUR-1008 25,000 Units

Drug

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: Zenpep

Kreon 25,000 Units

Drug

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: Kreon

Primary outcomes

  1. Coefficient of Fat Absorption over 72 hours (CFA-72h)

    Time frame: 72 hours

    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.

Secondary outcomes

  1. Body weight

    Time frame: 58 days.

    Body weight at baseline (Visit 2 [Day 0]) and at the end of each treatment period.

  2. Coefficient of nitrogen absorption

    Time frame: 72 hours

    Coefficient of nitrogen absorption at the end of each treatment period as assessed by a specialised central laboratory by means of Dumas combustion method.

  3. Control of signs and symptoms of EPI

    Time frame: 2- 14 day periods

    Control of signs and symptoms of EPI (as recorded in subject diaries). The following will be captured:

    • Stools frequency (number/day)
    • Stools consistency (hard, formed/normal; soft, watery, overt diarrhoea)
    • Fat or grease visible in stools (Yes/No)
    • Abdominal pain (mild, moderate, severe)
    • Bloating (mild, moderate, severe)
    • Flatulence (mild, moderate, severe)

  4. Impact on overall health, daily life, perceived well-being, and symptoms

    Time frame: 58 days

    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).

  5. Total cholesterol, calculated LDL-C, HDL-C

    Time frame: 58 days

    Total cholesterol, calculated LDL-C, HDL-C (sampling performed prior to randomisation and at the end of each treatment period).

  6. Treatment Emergent Adverse Events

    Time frame: 78 days

    Frequency, duration, and severity of treatment-emergent adverse events (TEAEs);

  7. Standard safety laboratory tests

    Time frame: 58 days

    Standard safety laboratory tests, analysed by central laboratory:

    • Haematology: red blood cell count, haemoglobin, haematocrit, total leukocytes with diff count, and platelets
    • Serum biochemistry: alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, total protein, albumin, total bilirubin, direct and indirect bilirubin, blood urea nitrogen, uric acid, creatinine, fasting plasma glucose, fasting cholesterol evaluations (total cholesterol, LDL-C, HDL-C, and triglycerides), fat-soluble vitamins (A, D, and E) and serum electrolytes

  8. Vital signs

    Time frame: 78 days

    Vital signs including blood pressure, heart rate, respirations and body temperature.

  9. Fat-soluble vitamins A, D, and E

    Time frame: 58 days

    Fat-soluble vitamins A, D, and E (sampling performed prior to randomisation and at the end of each treatment period).

Sponsors and collaborators

Lead sponsor

Forest Laboratories

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jul 16, 2012
Registry last updated
Mar 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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