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. 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.

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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:

MedlinePlus related topics: Pancreatitis

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 ]
The CFA is calculated from fat intake and fat excretion : 100*[fat intake-fat excretion]/fat intake. Higher values indicated a better response.

Change is calculated as (DB CFA-Baseline CFA).

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 ]
The CNA is calculated from nitrogen intake and nitrogen excretion : 100*[nitrogen intake-nitrogen excretion]/nitrogen intake. Higher values indicated a better response. Change is calculated as (DB CNA-Baseline CNA).
Change From Baseline of Stool Fat (g) Between Baseline and End of Double-blind (DB) Period. [ Time Frame: End of double-blind period (5-7 days) ] [ Designated as safety issue: No ]
Total amount of fat excreted during the stool collection period. Lower values indicate a better response. Change was calculated as (DB Stool fat - Baseline stool fat).
Change From Baseline of Stool Nitrogen (g) Between Baseline and End of Double-blind (DB) Period. [ Time Frame: End of double-period (5-7 days) ] [ Designated as safety issue: No ]
Total amount of nitrogen excreted during the stool collection period. Lower values indicate a better response. Change was calculated as (DB Stool nitrogen - Baseline stool nitrogen).
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 ]
Stool frequency is the average of the daily number of stools recorded during the treatment period. Lower values indicate a better response. Change was calculated as (DB stool frequency - Baseline Stool frequency).
Abdominal Pain at the End of the Double-blind Period. [ Time Frame: End of double-period (5-7 days) ] [ Designated as safety issue: No ]
4- point ordinal scale on this symptom from 0 (No Abdominal pain) to 3 (Severe abdominal pain).
Stool Consistency at the End of the Double-blind Period [ Time Frame: End of double-period (5-7 days) ] [ Designated as safety issue: No ]
4- point ordinal scale on this symptom from 0 (Hard) to 3 (Watery).
Flatulence at the End of Double-blind Period [ Time Frame: End of double-period (5-7 days) ] [ Designated as safety issue: No ]
4- point ordinal scale on this symptom from 0 (None) to 3 (Severe).

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

Arms	Assigned Interventions
Experimental: A	Drug: Pancrelipase delayed release capsule 24,000 unit capsule
Placebo Comparator: B	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:	Gregor Eibes, Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00414908 History of Changes
Other Study ID Numbers:	S245.3.124, 2004-000227-15
Study First Received:	December 21, 2006
Results First Received:	August 7, 2009
Last Updated:	August 8, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Solvay Pharmaceuticals:

Chronic Pancreatitis
Pancreatectomy
Pancreatic Exocrine Insufficiency

Additional relevant MeSH terms:

Exocrine Pancreatic Insufficiency
Pancreatitis
Pancreatitis, Chronic
Pancreatic Diseases
Digestive System Diseases

Pancrelipase
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012