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

Chronic Pancreatitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00414908
• Other study ID #: S245.3.124
• Secondary ID: 2004-000227-15
• Status: Completed
• Phase: Phase 3
• First received: December 21, 2006
• Last updated: August 8, 2011
• Start date: October 2007
• Est. completion date: December 2009

Study information

• Verified date: August 2011
• Source: Solvay Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: December 2009
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Chronic Pancreatitis
• Exocrine Pancreatic Insufficiency
• Pancreatectomy
• Pancreatic Exocrine Insufficiency
• Pancreatitis
• Pancreatitis, Chronic

Intervention

Drug:
• Pancrelipase delayed release capsule
24,000 unit capsule
• Placebo Comparator
Placebo

Locations

Country	Name	City	State
Bulgaria	Site 23	Sofia
Poland	Site 27	Warsaw
Puerto Rico	Site 19	San Juan
Russian Federation	Site 25	Leningrad
Serbia	Site 26	Belgrade
South Africa	Site 24	Cape Town
Ukraine	Site 28	Kiev
United States	Site 2	Ann Arbor	Michigan
United States	Site 6	Atlanta	Georgia
United States	Site 20	Boone	North Carolina
United States	Site 3	Boston	Massachusetts
United States	Site 22	Bristol	Connecticut
United States	Site 8	Cedar Knolls	New Jersey
United States	Site 17	Chicago	Illinois
United States	Site 10	Cincinnati	Ohio
United States	Site 11	Cleveland	Ohio
United States	Site 13	Dallas	Texas
United States	Site 29	Grand Rapids	Michigan
United States	Site 14	Indianapolis	Indiana
United States	Site 15	Kansas City	Kansas
United States	Site 16	Lexington	Kentucky
United States	Site 30	Maywood	Illinois
United States	Site 12	New Orleans	Louisiana
United States	Site 21	Pittsburgh	Pennsylvania
United States	Site 18	Richmond	Virginia
United States	Site 4	Rutherford College	North Carolina
United States	Site 9	Scottsdale	Arizona
United States	Site 5	St. Louis	Missouri
United States	Site 7	Tampa	Florida
United States	Site 1	Tupelo	Mississippi

Sponsors (1)

Lead Sponsor	Collaborator
Solvay Pharmaceuticals

Countries where clinical trial is conducted

United States,  Bulgaria,  Poland,  Puerto Rico,  Russian Federation,  Serbia,  South Africa,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Coefficient of Fat Absorption (CFA) (%) Between Baseline and End of Double-blind (DB) Period.	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).	End of double-blind period (5-7 days)	No
Secondary	Change of Coefficient of Nitrogen Absorption (CNA) (%) Between Baseline and End of Double-blind (DB) Period.	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).	End of double-blind period (5-7 days)	No
Secondary	Change From Baseline of Stool Fat (g) Between Baseline and End of Double-blind (DB) Period.	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).	End of double-blind period (5-7 days)	No
Secondary	Change From Baseline of Stool Nitrogen (g) Between Baseline and End of Double-blind (DB) Period.	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).	End of double-period (5-7 days)	No
Secondary	Change of Stool Frequency Between Baseline and End of Double-blind (DB) Period	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).	End of double-period (5-7 days)	No
Secondary	Abdominal Pain at the End of the Double-blind Period.	4- point ordinal scale on this symptom from 0 (No Abdominal pain) to 3 (Severe abdominal pain).	End of double-period (5-7 days)	No
Secondary	Stool Consistency at the End of the Double-blind Period	4- point ordinal scale on this symptom from 0 (Hard) to 3 (Watery).	End of double-period (5-7 days)	No
Secondary	Flatulence at the End of Double-blind Period	4- point ordinal scale on this symptom from 0 (None) to 3 (Severe).	End of double-period (5-7 days)	No