A Randomized, Double-Blind, Dose Response-Control, Crossover Study to Evaluate the Safety and Efficacy of Two Doses of EUR-1008 (APT-1008) in Chronic Pancreatitis (CP) Participants With Exocrine Pancreatic Insufficiency (EPI)
Completed · Phase 3 · Has a placebo group
Conditions studied: Chronic Pancreatitis, Exocrine Pancreatic Insufficiency
In brief
The primary efficacy objective of this study is to evaluate the difference in coefficient of fat absorption (CFA) of participants treated with high dose EUR-1008 (APT-1008) versus low dose of EUR-1008 (APT-1008) in the treatment of signs and symptoms of malabsorption in participants with EPI associated with CP. This study is sponsored by Aptalis Pharma (formerly Eurand).
Key facts
- Study ID
- NCT00788593
- Run by
- Forest Laboratories
- People needed
- 82
- Starts
- 2008-01-01
- Expected to finish
- 2009-03-01
- Last updated by the study team
- 2014-03-12
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Participants are male or female
- Participants with age over 18 years
- Participants who have written, legally valid informed consent
- Women of childbearing potential must be using a medically acceptable form of birth control for the 30 days prior to the beginning of the study and agree to maintain adequate birth control measures during the whole duration of the study plus an additional 30 days as well as have a negative pregnancy test at screening Visit 3 and Visit 7
- Participants with documented diagnosis of CP by medical history and it is preferred that it is supported by imaging evidence confirming CP which include: abnormal endoscopic retrograde cholangio-pancreatography (ERCP) (Cambridge Class 4), abnormal computed tomography (CT) scan (dilated main pancreatic duct, atrophy of the pancreas or calcification), abnormal ultrasound, or endoscopic ultrasound with at least 5 abnormalities noted
- In the case of pancreatic surgery, the participant can be included with partial or distal resection of the pancreas (not due to cancer)
- Participants with documented EPI with target fecal elastase (FE) less than or equal to 100 microgram per gram (mcg/g) of stool using the monoclonal test (pancreatic elastase 1 [PE1] by Genova Diagnostics) performed at the screening visit. The mean coefficient of variation (CV) for the FE test is 20 percent (%)
You may not qualify if…
- Participants known to the investigator to have a significant medical and/or mental disease that would compromise the participant's welfare, pose an unacceptable risk to him/her or confound the study results
- Participants who participated in a clinical trial within 30 days of randomization or per specific country regulations/guidelines
- Participants with cystic fibrosis
- Participants with excessive alcohol consumption
- Participants with drug abuse
- Participants with contraindicated medications or who are unable to discontinue prohibited concomitant medication
- Participants with uncontrolled diabetes mellitus
- Participants allergic to pork protein/unwilling to ingest pork products
- Participants with atopic predisposition such as multiple drug hypersensitivity, allergic asthma, urticaria, or other relevant allergic diathesis
- Participants who are pregnant or lactating
- Participants with acute pancreatitis or acute exacerbation in chronic pancreatitis
- Participants with acute biliary disease
- Participants with malabsorption syndrome caused by a metabolic disease or by surgery, not related to exocrine pancreatic insufficiency
- Participants with any resection of the stomach or the gastrointestinal tract that will affect transit time and/or gastric emptying.
- Participants with evidence of active gastric or duodenal ulcer
- Participants with chronic inflammatory bowel disease
- Participants with any history of pancreatic cancer and other non-cutaneous malignancies (except basal cell and squamous cell carcinoma of the skin in situ that have been removed and not reoccurred in 5 years)
- Participants with viral hepatitis with infectious virions in blood and/or body fluids (any etiology)
- Participants with human immunodeficiency virus (HIV) infection
- Participants with hyperuricemia ( greater than [>] 1.5 times upper normal value for lab)
- Participants with any acute or chronic disease, which in the opinion of the investigator could influence study results or pose a risk to the participants' safety
Where it is running
- Woodland International Research Group — Little Rock, Arkansas, United States
- HealthCare Partners Medical Group — Los Angeles, California, United States
- University of Florida, General Clinical Research Center — Gainesville, Florida, United States
- Advanced Medical Research Center — Port Orange, Florida, United States
- Veterans Affairs Edward Jr. Hines Hospital, Building #1 — Hines, Illinois, United States
- University of Iowa Hospitals and Clinics — Iowa Ctiy, Iowa, United States
- University of Kentucky, Medical Center, Department of Gastroenterology — Lexington, Kentucky, United States
- University of Louisville, Carmichael Building — Louisville, Kentucky, United States
- University of Missouri Health Care — Columbia, Missouri, United States
- Dipartmento di Malattie dell' apparato digerente e Medicina Interna- Unita Operativa di MedicinaInterna Corinaldesi Azienda Ospedaliero- Universitaria Policlinico Sant'Orsola Malpighi Via Massarenti — Massarenti, Bologna, Italy
- Istituto Clinico Humanitas - Universita' Di Milano Via Manzoni — Rozzano, Milano, Italy
- Istituto di Clinica Chirurgica (Ensoscopia Digestive Chirurgica) Policlinico Gemelli-Universita Cattolica del Sacro Cuore — Largo Agostino Gemelli, Roma, Italy
- Centro Richerche Cliniche di Verona — Le Ludovico Scuro, Verona, Italy
- Department of Therapy and Family Medicine of the Facility of Post graduate Education of Crimea State Medical University named after S.I. Georglyevskyy Republic Clinical Hospital named after M.O. Semashko — Simferopol, Autonomous Republic of Crimea, Ukraine
- Department of Internal Medicine No 2 of Donetsk State University named after M. Gorkly, City Clinical Hospital No 3 — Donetsk, Donetsk Oblast, Ukraine
- Department of Liver and Gastrointestinal Tract Disease Institute of Therapy named after L.T. Maylaya of Academy of Medical Sciences of the Ukraine — Kharkiv, Kharklv, Ukraine
- Department of Faculty Therapy No 1 with the Course of Postgraduate Training of Physicians for Gastroenterology and Endoscopy, National Medical University named after O.O. Bogomolets, City Hospital No 18 — Kyiv, Kylv, Ukraine
- General Therapy Clinic, Military Clinical Hospital of Ministry of Defense of Ukraine 18 — Kyiv, Kylv, Ukraine
Full record on ClinicalTrials.gov
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