A Study to Investigate the Effect of Delayed Release Pancrelipase on Maldigestion in Patients With Exocrine Pancreatic Insufficiency Due to Chronic Pancreatitis and Pancreatectomy - Full Text View

Sponsor:	Solvay Pharmaceuticals
Information provided by:	Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00414908

Purpose

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.

Condition	Intervention	Phase
Chronic Pancreatitis Pancreatectomy Pancreatic Exocrine Insufficiency	Drug: Pancrelipase delayed release capsule Drug: Placebo Comparator	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

Drug Information available for: Pancrelipase Ultrase

U.S. FDA Resources

Further study details as provided by Solvay Pharmaceuticals:

Primary Outcome Measures:

Change of Coefficient of Fat Absorption (CFA) (%) Between Baseline and End of Double-blind (DB) Period. [ Time Frame: End of double-blind period (5-7 days) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change of Coefficient of Nitrogen Absorption (CNA) (%) Between Baseline and End of Double-blind (DB) Period. [ Time Frame: End of double-blind period (5-7 days) ] [ Designated as safety issue: No ]
Change From Baseline of Stool Fat (g) Between Baseline and End of Double-blind (BD) Period. [ Time Frame: End of double-blind period (5-7 days) ] [ Designated as safety issue: No ]
Change From Baseline of Stool Nitrogen (g) Between Baseline and End of Double-blind (BD) Period. [ Time Frame: End of double-period (5-7 days) ] [ Designated as safety issue: No ]
Change of Stool Frequency Between Baseline and End of Double-blind (DB) Period [ Time Frame: End of double-period (5-7 days) ] [ Designated as safety issue: No ]
Abdominal Pain at the End of the Double-blind Period. [ Time Frame: End of double-period (5-7 days) ] [ Designated as safety issue: No ]
Stool Consistency at the End of the Double-blind Period [ Time Frame: End of double-period (5-7 days) ] [ Designated as safety issue: No ]
Flatulence at the End of Double-blind Period [ Time Frame: End of double-period (5-7 days) ] [ Designated as safety issue: No ]

Enrollment:	52
Study Start Date:	October 2007
Study Completion Date:	April 2009
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: Pancrelipase delayed release capsule 24,000 unit capsule
B: Placebo Comparator	Drug: Placebo Comparator Placebo

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00414908

Show 30 Study Locations

Sponsors and Collaborators

Solvay Pharmaceuticals

Investigators

Study Director:

Global Clinical Director Solvay

Solvay Pharmaceuticals

More Information

No publications provided

Responsible Party:	Solvay Pharmaceuticals ( Gregor Eibes )
Study ID Numbers:	S245.3.124, 2004-000227-15
Study First Received:	December 21, 2006
Results First Received:	August 7, 2009
Last Updated:	August 7, 2009
ClinicalTrials.gov Identifier:	NCT00414908 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Solvay Pharmaceuticals:

Chronic Pancreatitis
Pancreatectomy
Pancreatic Exocrine Insufficiency

Additional relevant MeSH terms:

Digestive System Diseases
Therapeutic Uses
Gastrointestinal Agents
Pancreatic Diseases
Pancrelipase

Pharmacologic Actions
Pancreatitis
Exocrine Pancreatic Insufficiency
Pancreatitis, Chronic

ClinicalTrials.gov processed this record on February 08, 2010