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)

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Brief 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)

Official 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)

Brief Summary

      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).
    

Detailed Description

      After screening, eligible participants will start the placebo baseline ambulatory phase (4
      days). On day 5, they will be hospitalized for three to five days, to undergo a "baseline"
      72-hour CFA determination under a controlled diet and using a stool marker to indicate the
      beginning and end of the controlled diet period, while they continue receiving placebo
      treatment. At the end of the placebo baseline phase, participants will be randomized to a
      "high dose followed by a low dose" or to a "low dose followed by a high dose" EUR-1008
      (APT-1008) dose sequence and proceed to the first crossover (treatment) phase. Each crossover
      (treatment) phase will consist of a stabilization period for six days at home, followed by a
      hospitalization of three to five days to undergo a 72-hour CFA determination using a
      controlled diet and using a stool marker to indicate the beginning and end of the controlled
      diet period.

      Participants will immediately proceed from the first crossover (treatment) phase to the
      second without a washout period or return-to-baseline period in between phases. Participants
      will be stabilized at home for 6 days. Any residual lipase from the prior treatment phase is
      likely to be a negligible influence on the subsequent CFA determination because participants
      will be taking the new dose level (high or low) for six days before the beginning of sample
      collection for a new CFA. This interval is more than enough time for the CFA to be reflective
      of only the new dose.
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Percent Coefficient of Fat Absorption (CFA) of Participants Treated With High Dose EUR-1008 and Low Dose EUR-1008

Secondary Outcome

 Change From Placebo Baseline in Percent Coefficient of Fat Absorption (CFA) in High Dose EUR-1008 and Low Dose EUR-1008 During Hospital Treatment

Condition

Chronic Pancreatitis

Intervention

Placebo

Study Arms / Comparison Groups

 Placebo
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

82

Start Date

January 2008

Completion Date

March 2009

Primary Completion Date

March 2009

Eligibility 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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Aptalis Medical Information, , 

Location Countries

Italy

Location Countries

Italy

Administrative Informations


NCT ID

NCT00788593

Organization ID

PR-002


Responsible Party

Sponsor

Study Sponsor

Forest Laboratories


Study Sponsor

Aptalis Medical Information, Study Director, Forest Laboratories


Verification Date

January 2014