Clinical trial NCT00510484: Study Investigating a Delayed-Release Pancrelipase in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis
Official title: A Double-blind, Randomized, Multi-center, Placebo-controlled, Cross-over Study to Assess the Efficacy and Safety of Pancrelipase Delayed Release 24,000 Unit Capsules in Subjects With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cystic Fibrosis
Keywords: Pancreatic exocrine insufficiency
Cystic Fibrosis
Lead sponsor: Solvay Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2007-08-02
Enrollment: 35
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess the effect of pancrelipase delayed release 24,000 unit capsules on fat and nitrogen absorption in subjects with PEI due to Cystic Fibrosis.


Eligibility criteria: Inclusion Criteria:

* Confirmed CF diagnosis by two positive chloride sweat tests or gene analysis
* Confirmed PEI by historical CFA \< 70% without supplementation or current or historical fecal elastase \< 50µg/g stool (within the last 12 months)
* Subjects of 12 years or older
* Currently receiving treatment with a commercially available pancreatic enzyme product on a stable dose for more than 3 months
* Clinically stable condition without evidence of acute respiratory disease or any other acute condition
* Females of child-bearing potential must agree to continue using a medically acceptable method of birth control

Exclusion Criteria:

* Ileus or acute abdomen
* History of fibrosing colonopathy
* History of distal ileal obstruction syndrome within 6 months of enrollment
* Use of an immunosuppressive drug
* Any type of malignancy involving the digestive tract in the last 5 years
* Known infection with HIV

Primary outcomes:
measure: Coefficient of Fat Absorption (%)
timeFrame: 5 days
Secondary outcomes:
measure: Coefficient of Nitrogen Absorption (%)
timeFrame: 5 days
measure: Total Fat Excretion (Grams)
timeFrame: 5 days
measure: Total Stool Weight (Grams)
timeFrame: 5 days
measure: Stool Frequency
timeFrame: 5 days
measure: Percentage of Days With no Flatulence.
timeFrame: 5 days
measure: Percentage of Days With no Abdominal Pain.
timeFrame: 5 days
Other outcomes:
measure: Percentage of Days With Formed/Normal Stools.
timeFrame: 5 days
Locations:
city: Long Beach
country: United States
facility: Site 11
state: California
city: Los Angeles
country: United States
facility: Site 10
state: California
city: San Francisco
country: United States
facility: Site 13
state: California
city: Miami
country: United States
facility: Site 5
state: Florida
city: Orlando
country: United States
facility: Site 4
state: Florida
city: Iowa City
country: United States
facility: Site 1
state: Iowa
city: Louisville
country: United States
facility: Site 7
state: Kentucky
city: Boston
country: United States
facility: Site 17
state: Massachusetts
city: Ann Arbor
country: United States
facility: Site 8
state: Michigan
city: Minneapolis
country: United States
facility: Site 6
state: Minnesota
city: Long Branch
country: United States
facility: Site 18
state: New Jersey
city: Albuquerque
country: United States
facility: Site 16
state: New Mexico
city: Cincinnati
country: United States
facility: Site 19
state: Ohio
city: Dayton
country: United States
facility: Site 12
state: Ohio
city: Toledo
country: United States
facility: Site 2
state: Ohio
city: Oklahoma City
country: United States
facility: Site 14
state: Oklahoma
city: Hershey
country: United States
facility: Site 3
state: Pennsylvania
city: Philadelphia
country: United States
facility: Site 15
state: Pennsylvania
city: Nashville
country: United States
facility: Site 9
state: Tennessee
city: Petrofi
country: Hungary
facility: Site 20
city: Jerusalem
country: Israel
facility: Site 21
city: Johannesburg
country: South Africa
facility: Site 22
city: Barcelona
country: Spain
facility: Site 23
Study officials:
affiliation: Solvay Pharmaceuticals
name: Global Clinical Director Solvay
role: STUDY_DIRECTOR
References:
citation: Trapnell BC, Maguiness K, Graff GR, Boyd D, Beckmann K, Caras S. Efficacy and safety of Creon 24,000 in subjects with exocrine pancreatic insufficiency due to cystic fibrosis. J Cyst Fibros. 2009 Dec;8(6):370-7. doi: 10.1016/j.jcf.2009.08.008. Epub 2009 Oct 7.