A Study to Investigate the Effect of Delayed Release Pancrelipase on Maldigestion in Patients With Exocrine Pancreatic Insufficiency Due to Chronic Pancreatitis and Pancreatectomy
Completed · Phase 3 · Has a placebo group
Conditions studied: Chronic Pancreatitis, Pancreatectomy, Pancreatic Exocrine Insufficiency
In brief
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.
Key facts
- Study ID
- NCT00414908
- Run by
- Solvay Pharmaceuticals
- People needed
- 52
- Starts
- 2007-10-01
- Expected to finish
- 2009-12-01
- Last updated by the study team
- 2011-08-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Site 9 — Scottsdale, Arizona, United States
- Site 22 — Bristol, Connecticut, United States
- Site 7 — Tampa, Florida, United States
- Site 6 — Atlanta, Georgia, United States
- Site 17 — Chicago, Illinois, United States
- Site 30 — Maywood, Illinois, United States
- Site 14 — Indianapolis, Indiana, United States
- Site 15 — Kansas City, Kansas, United States
- Site 16 — Lexington, Kentucky, United States
- Site 12 — New Orleans, Louisiana, United States
- Site 3 — Boston, Massachusetts, United States
- Site 2 — Ann Arbor, Michigan, United States
- Site 29 — Grand Rapids, Michigan, United States
- Site 1 — Tupelo, Mississippi, United States
- Site 5 — St Louis, Missouri, United States
- Site 8 — Cedar Knolls, New Jersey, United States
- Site 20 — Boone, North Carolina, United States
- Site 4 — Rutherford College, North Carolina, United States
- Site 10 — Cincinnati, Ohio, United States
- Site 11 — Cleveland, Ohio, United States
- Site 21 — Pittsburgh, Pennsylvania, United States
- Site 13 — Dallas, Texas, United States
- Site 18 — Richmond, Virginia, United States
- Site 23 — Sofia, Bulgaria
- Site 27 — Warsaw, Poland
Full record on ClinicalTrials.gov
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