Clinical trial NCT00414908: A Study to Investigate the Effect of Delayed Release Pancrelipase on Maldigestion in Patients With Exocrine Pancreatic Insufficiency Due to Chronic Pancreatitis and Pancreatectomy
Official title: A Study to Investigate the Effect of Delayed Release Pancrelipase on Maldigestion in Patients With Exocrine Pancreatic Insufficiency Due to Chronic Pancreatitis and Pancreatectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Pancreatitis
Pancreatectomy
Pancreatic Exocrine Insufficiency
Keywords: Chronic Pancreatitis
Pancreatectomy
Pancreatic Exocrine Insufficiency
Lead sponsor: Solvay Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2006-12-22
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study assessed the effect of pancrelipase delayed release capsules on fat and nitrogen absorption in subjects with PEI due to Chronic Pancreatitis and Pancreatectomy. There was a run-in with a 5-day of single-blind placebo treatment, followed by a 7-day Double-blind period and a 6-month Open-Label Follow-up.


Eligibility criteria: Inclusion Criteria:

Pancreatic exocrine insufficiency has to be proven (in medical history) by the following criteria:

* Direct or indirect pancreatic function test (except stool fat excretion) or Clinical signs of severe steatorrhoea that resolved upon administration of pancreatic supplementation.
* Total stool fat \> 40 g over 4 days (using Van De Kamer method)
* Proven chronic pancreatitis
* Females of child-bearing potential must agree to continue using a medically acceptable method of birth control

Exclusion Criteria:

* Ileus or acute abdomen
* Any type of malignancy involving the digestive tract in the last 5 years
* Presence of pseudo-pancreatic cyst ≥ 4
* Continued excessive intake of alcohol or drug abuse
* Known infection with HIV

Primary outcomes:
measure: Change of Coefficient of Fat Absorption (CFA) (%) Between Baseline and End of Double-blind (DB) Period.
timeFrame: End of double-blind period (5-7 days)
Secondary outcomes:
measure: Change of Coefficient of Nitrogen Absorption (CNA) (%) Between Baseline and End of Double-blind (DB) Period.
timeFrame: End of double-blind period (5-7 days)
measure: Change From Baseline of Stool Fat (g) Between Baseline and End of Double-blind (DB) Period.
timeFrame: End of double-blind period (5-7 days)
measure: Change From Baseline of Stool Nitrogen (g) Between Baseline and End of Double-blind (DB) Period.
timeFrame: End of double-period (5-7 days)
measure: Change of Stool Frequency Between Baseline and End of Double-blind (DB) Period
timeFrame: End of double-period (5-7 days)
measure: Abdominal Pain at the End of the Double-blind Period.
timeFrame: End of double-period (5-7 days)
measure: Stool Consistency at the End of the Double-blind Period
timeFrame: End of double-period (5-7 days)
measure: Flatulence at the End of Double-blind Period
timeFrame: End of double-period (5-7 days)
Other outcomes:
measure: Change of Stool Frequency Between "Original" Baseline and End of Open-label Period (OL)
timeFrame: 27 weeks
Locations:
city: Scottsdale
country: United States
facility: Site 9
state: Arizona
city: Bristol
country: United States
facility: Site 22
state: Connecticut
city: Tampa
country: United States
facility: Site 7
state: Florida
city: Atlanta
country: United States
facility: Site 6
state: Georgia
city: Chicago
country: United States
facility: Site 17
state: Illinois
city: Maywood
country: United States
facility: Site 30
state: Illinois
city: Indianapolis
country: United States
facility: Site 14
state: Indiana
city: Kansas City
country: United States
facility: Site 15
state: Kansas
city: Lexington
country: United States
facility: Site 16
state: Kentucky
city: New Orleans
country: United States
facility: Site 12
state: Louisiana
city: Boston
country: United States
facility: Site 3
state: Massachusetts
city: Ann Arbor
country: United States
facility: Site 2
state: Michigan
city: Grand Rapids
country: United States
facility: Site 29
state: Michigan
city: Tupelo
country: United States
facility: Site 1
state: Mississippi
city: St. Louis
country: United States
facility: Site 5
state: Missouri
city: Cedar Knolls
country: United States
facility: Site 8
state: New Jersey
city: Boone
country: United States
facility: Site 20
state: North Carolina
city: Rutherford College
country: United States
facility: Site 4
state: North Carolina
city: Cincinnati
country: United States
facility: Site 10
state: Ohio
city: Cleveland
country: United States
facility: Site 11
state: Ohio
city: Pittsburgh
country: United States
facility: Site 21
state: Pennsylvania
city: Dallas
country: United States
facility: Site 13
state: Texas
city: Richmond
country: United States
facility: Site 18
state: Virginia
city: Sofia
country: Bulgaria
facility: Site 23
city: Warsaw
country: Poland
facility: Site 27
city: San Juan
country: Puerto Rico
facility: Site 19
city: Leningrad
country: Russian Federation
facility: Site 25
city: Belgrade
country: Serbia
facility: Site 26
city: Cape Town
country: South Africa
facility: Site 24
city: Kiev
country: Ukraine
facility: Site 28
Study officials:
affiliation: Solvay Pharmaceuticals
name: Global Clinical Director Solvay
role: STUDY_DIRECTOR
References: