Phase 3
N=54
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 · Pancreatectomy · Pancreatic Exocrine Insufficiency
Bottom Line
View on ClinicalTrials.gov: NCT00414908 ↗Enrolled (actual)
54
Serious AEs
6.8%
Results posted
Sep 2009
Primary outcome: Primary: Change of Coefficient of Fat Absorption (CFA) (%) Between Baseline and End of Double-blind (DB) Period. — 31.93; 8.72 Percentage — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Pancrelipase delayed release capsule (Drug); Placebo Comparator (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Solvay Pharmaceuticals
- Primary completion
- Aug 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change of Coefficient of Fat Absorption (CFA) (%) Between Baseline and End of Double-blind (DB) Period. |
31.93; 8.72 | <0.0001 sig |
| SECONDARY Change of Coefficient of Nitrogen Absorption (CNA) (%) Between Baseline and End of Double-blind (DB) Period. |
35.23; 8.85 | 0.0002 sig |
| SECONDARY Change From Baseline of Stool Fat (g) Between Baseline and End of Double-blind (DB) Period. |
-147.08; -34.62 | <0.0001 sig |
| SECONDARY Change From Baseline of Stool Nitrogen (g) Between Baseline and End of Double-blind (DB) Period. |
-17.55; -5.87 | <0.0001 sig |
| SECONDARY Change of Stool Frequency Between Baseline and End of Double-blind (DB) Period |
-0.55; 0.20 | 0.005 sig |
| SECONDARY Abdominal Pain at the End of the Double-blind Period. |
12; 8; 7; 12; 4; 7 | — |
| SECONDARY Stool Consistency at the End of the Double-blind Period |
0; 0; 11; 5; 12; 20 | — |
| SECONDARY Flatulence at the End of Double-blind Period |
6; 0; 13; 15; 4; 12 | — |
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
Data sourced from ClinicalTrials.gov (NCT00414908). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.