Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01641393
Recruitment Status : Completed
First Posted : July 16, 2012
Last Update Posted : March 14, 2014
Sponsor:
Information provided by (Responsible Party):
Forest Laboratories

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Exocrine Pancreatic Insufficiency: Cystic Fibrosis Drug: EUR-1008 25,000 Units Drug: Kreon 25,000 Units Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Study Start Date : June 2012
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arm Intervention/treatment
Experimental: EUR-1008 then Kreon
  • EUR-1008 during Treatment Period 1 (29 days ±2 days) and
  • Kreon during Treatment Period 2 (29 days ±2 days).
Drug: EUR-1008 25,000 Units
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 Name: Zenpep

Drug: Kreon 25,000 Units
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 Name: Kreon

Experimental: Kreon then EUR-1008
  • Kreon during Treatment Period 1 (29 days ±2 days) and
  • EUR-1008 during Treatment Period 2 (29 days ±2 days).
Drug: EUR-1008 25,000 Units
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 Name: Zenpep

Drug: Kreon 25,000 Units
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 Name: Kreon




Primary Outcome Measures :
  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 Outcome Measures :
  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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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. 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
  2. Pancreatic insufficiency documented by a monoclonal faecal elastase (FE) 100 μg/g stool at screening (test results within the previous 12 months are acceptable)
  3. Currently receiving pancreatic enzyme replacement therapy
  4. 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
  5. 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:

  1. Age <12 years
  2. Known contraindication, hypersensitivity, or intolerance to pork or other porcine PEPs
  3. Current uncontrolled diabetes mellitus
  4. History of solid organ transplantation
  5. History of surgery affecting the bowel function and weight gain

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): NCT01641393


Locations
Show Show 37 study locations
Sponsors and Collaborators
Forest Laboratories
Investigators
Layout table for investigator information
Principal Investigator: Christopher Taylor, MD, PhD Sheffield Children's Hospital, The Academic Unit of Child Health

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01641393    
Other Study ID Numbers: PR-005
2009-012842-21 ( EudraCT Number )
First Posted: July 16, 2012    Key Record Dates
Last Update Posted: March 14, 2014
Last Verified: March 2014
Keywords provided by Forest Laboratories:
Exocrine Pancreatic Insufficiency
Cystic Fibrosis
Pancreatic Insufficiency
Additional relevant MeSH terms:
Layout table for MeSH terms
Cystic Fibrosis
Exocrine Pancreatic Insufficiency
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases