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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00414908
• Date of registration: 21/12/2006
• Prospective Registration: Yes
• Primary sponsor: Solvay Pharmaceuticals
• Public 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
• Scientific 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
• Date of first enrolment: October 2007
• Target sample size: 52
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00414908
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

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

Contacts

• Name: Global Clinical Director Solvay
• Affiliation: Solvay Pharmaceuticals

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Pancreatectomy

Chronic Pancreatitis

Pancreatic Exocrine Insufficiency

Intervention(s)

Drug: Placebo Comparator

Drug: Pancrelipase delayed release capsule

Primary Outcome(s)

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)]

Secondary Outcome(s)

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)]

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)]

Change of Stool Frequency Between Baseline and End of Double-blind (DB) Period [Time Frame: End of double-period (5-7 days)]

Stool Consistency at the End of the Double-blind Period [Time Frame: End of double-period (5-7 days)]

Abdominal Pain at the End of the Double-blind Period. [Time Frame: End of double-period (5-7 days)]

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)]

Flatulence at the End of Double-blind Period [Time Frame: End of double-period (5-7 days)]

Secondary ID(s)

2004-000227-15

S245.3.124

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 16/09/2009
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00414908