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

Trial Source

There is no location for this trial

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Health Conditions
  • Exocrine Pancreatic Insufficiency: Cystic Fibrosis
Unfortunately contact details are not available for this trial.
Primary Contact Details
Completed
Recruitment Status
NCT01641393
Primary Trial ID Number
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.
Research Details
    Sorry, this information is not available
Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Study Type
Interventional
Intervention
Drug : EUR-1008 25,000 Units, Drug : Kreon 25,000 Units

Study Arm Groups : EUR-1008 then Kreon, Kreon then EUR-1008, EUR-1008 then Kreon, Kreon then EUR-1008

Intervention Type
See Interventions above
Primary Outcome Measures
  • Coefficient of Fat Absorption over 72 hours (CFA-72h); 72 hours
Secondary Outcome Measures
  • Body weight; 58 days.; Coefficient of nitrogen absorption; 72 hours; Control of signs and symptoms of EPI; 2- 14 day periods; Impact on overall health, daily life, perceived well-being, and symptoms; 58 days; Total cholesterol, calculated LDL-C, HDL-C; 58 days; Treatment Emergent Adverse Events; 78 days; Standard safety laboratory tests; 58 days; Vital signs; 78 days; Fat-soluble vitamins A, D, and E; 58 days
Publication(s)
Sorry, this information is not available
Result Reports
This is available on the Clinicaltrials.gov website
Gender
Both
Age Range
12 Years - N/A
Who Can Participate
Patients
Number of Participants
Sorry, this information is not available
Participant Inclusion 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
Participant Exclusion Criteria
This is in the inclusion criteria above
Trial Location(s)
Liverpool
Liverpool
Sheffield
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
Belgium, Bulgaria, France, Germany, Italy, Poland, United Kingdom
Scientific 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
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
PR-005
Sponsor(s)
Forest Laboratories
Key Dates

Recruitment Start Date

Jun 2012

Recruitment End Date

Feb 2014

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date Assigned

10 Jul 2012

Last Updated

13 Mar 2014