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)

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00788593
• Date of registration: 10/11/2008
• Prospective Registration: No
• Primary sponsor: Forest Laboratories
• Public title: 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)
• Scientific title: A Randomized, Double-Blind, Dose Response-Control, Crossover Study to Evaluate the Safety and Efficacy of Two Doses of EUR-1008 in Chronic Pancreatitis (CP) Patients With Exocrine Pancreatic Insufficiency (EPI)
• Date of first enrolment: January 2008
• Target sample size: 82
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00788593
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Italy, Ukraine, United States

Contacts

• Name: Aptalis Medical Information
• Affiliation: Forest Laboratories

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 (%)

Exclusion Criteria:

- 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



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

Health Condition(s) or Problem(s) studied

Exocrine Pancreatic Insufficiency

Chronic Pancreatitis

Intervention(s)

Drug: EUR-1008 (APT-1008) High Dose

Drug: EUR-1008 (APT-1008) Low Dose

Drug: Placebo

Primary Outcome(s)

Percent Coefficient of Fat Absorption (CFA) of Participants Treated With High Dose EUR-1008 and Low Dose EUR-1008 [Time Frame: 3 to 5 days of hospital treatment in first and second intervention periods]

Secondary Outcome(s)

Change From Placebo Baseline in Weight at End of Each Treatment Period [Time Frame: Baseline, end of treatment (6 days home treatment and 3-5 days hospital treatment in first and second intervention periods)]

Change From Placebo Baseline in Percent Coefficient of Fat Absorption (CFA) in High Dose EUR-1008 and Low Dose EUR-1008 During Hospital Treatment [Time Frame: Baseline, 3 to 5 days of hospital treatment in first and second intervention periods]

Change From Placebo Baseline in Percent Coefficient of Nitrogen Absorption (CNA) During Hospital Treatment [Time Frame: Baseline, 3 to 5 days of hospital treatment in first and second intervention periods]

Change From Placebo Baseline in Body Mass Index (BMI) at End of Treatment [Time Frame: Baseline, end of treatment (6 days home treatment and 3-5 days hospital treatment in first and second intervention periods)]

Secondary ID(s)

PR-002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 12/03/2014
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00788593