Safety and Efficacy Study of Viokase® 16 for the Correction of Steatorrhea

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Brief Title

Safety and Efficacy Study of Viokase® 16 for the Correction of Steatorrhea

Official Title

A Multicenter, Randomized, Double-blind, Parallel, Placebo-controlled, Phase III Study to Assess the Safety and Efficacy of Viokase® 16 for the Correction of Steatorrhea in Patients With Exocrine Pancreatic Insufficiency

Brief Summary

      This study assesses the efficacy and safety of Viokase® 16 for the correction of steatorrhea
      (malabsorption of dietary fats) in patients with a history of exocrine pancreatic
      insufficiency (EPI) due to chronic pancreatitis (CP) or pancreatectomy. This study is
      sponsored by Aptalis Pharma (formerly Axcan).
    

Detailed Description

      This study is a Phase III, multicenter, randomized, double-blind, parallel,
      placebo-controlled study, to assess the efficacy and safety of Viokase® 16 for the correction
      of steatorrhea in patients with EPI due to CP or pancreatectomy. The study will include the
      following phases: screening phase (up to 10 days), wash-out phase (6 to 7 days),
      randomization phase (up to 10 days), and treatment phase (6 to 7 days).

      In screening phase, patients will undergo screening procedures prior to entry into the study.

      In wash-out phase, stool collection will be performed to allow determination of the baseline
      CFA.

      In randomization phase, patients who qualify for the Treatment Phase (that is, patients who
      have a CFA% below 80%) will be randomized in the study.

      In the treatment phase, patients will be randomized in a 2:1 ratio (Viokase® 16 or Placebo).
      In treatment phase, stool collection period will be performed to allow determination of the
      CFA% that will serve to assess the efficacy of Viokase® 16 for the correction of steatorrhea.
      Follow-up procedures will be scheduled 7 to 10 days after discharge. Patients who do not show
      abnormal findings, adverse events or concomitant medications during the treatment phase will
      be assessed via follow-up telephone call. Patients who show abnormal findings (physical
      examination, vital signs, clinical laboratory tests, adverse events, concomitant medications)
      during the treatment phase will complete a follow-up visit.
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Percent Coefficient of Fat Absorption (CFA)

Secondary Outcome

 Mean Daily Number of Stools

Condition

Exocrine Pancreatic Insufficiency

Intervention

Viokase® 16

Study Arms / Comparison Groups

 Viokase® 16
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

50

Start Date

November 2007

Completion Date

July 2009

Primary Completion Date

July 2009

Eligibility Criteria

        Inclusion Criteria:

          -  Patient must be male or female, aged 18-80 years

          -  Patients must have the ability to provide informed consent

          -  Female patients of childbearing potential must have a negative pregnancy test at
             screening, must use adequate contraception prior to and during the study and must
             agree not to attempt to become pregnant during the study; and female patients of
             non-childbearing potential must be surgically sterile or postmenopausal for at least
             12 consecutive months

          -  Patients must have a medical condition compatible with EPI such as chronic
             pancreatitis or partial or total resection of the pancreas

          -  Patients with CP due to alcohol abuse may be included provided they show no clinical
             symptoms of recent alcohol consumption and no alcohol withdrawal symptoms

          -  Patients with CP must have at least one of the following conditions: an abnormal
             secretin test, diffuse calcification of the pancreas on plain film of the abdomen, an
             abnormal endoscopic retrograde cholangiopancreatography (ERCP) or endoscopic
             ultrasound, an abnormal computed tomography (CT) (dilated main pancreatic duct,
             atrophy or calcification of the pancreas) or serum trypsin concentration below 20
             nanogram per milliliter (ng/mL)

          -  Patients must have evidence of EPI as demonstrated by a fecal elastase (FE-1)
             determination equal to or below 100 microgram/gram (mcg/g) of stools (FE-1 ScheBo
             test) at screening

          -  Patients must have evidence of EPI as manifested by a CFA% below 80% after the
             wash-out phase

          -  Patients must be able to comply with a high-fat diet

        Exclusion Criteria:

          -  Patients with a known hypersensitivity and/or contraindication to any of the study
             medications, to their excipients, components or to Federal Food, Drug, and Cosmetic
             (FD and C) Blue No. 2 dye marker

          -  Patients with acute pancreatitis or with an acute exacerbation of CP at screening or
             within the last 2 weeks before screening

          -  Patients with any active or recurrent malignant pancreatic tumor

          -  Patients with a history of significant bowel resection

          -  Patients with a dysmotility disorder

          -  Patients with insufficient body mass (body mass index less than 18)

          -  Patient not willing to be off therapeutic doses for at least 7 days prior to study
             entry and throughout the course of the study, medications or products that could
             interfere with fecal fat excretion

          -  Patients who do not limit alcohol intake to less than or equal to 1 drink per day
             during screening and randomization phases and patients who do not refrain from
             drinking during inpatient periods of the study

          -  Patients who have been treated with the following drugs within 7 days prior to
             screening: H2-receptor antagonists, gastrointestinal anticholinergics and
             antispasmodics

          -  Patients known to have a significant medical and/or mental disease that would
             compromise the patient's welfare or confound the study results

          -  Patients with a history of fibrosing colonopathy, cirrhosis of the liver, or portal
             hypertension

          -  Patients who have a condition known to increase fecal fat loss including celiac
             disease, biliary cancer, biliary stricture, cholelithiasis, Crohn's disease,
             pancreatic cancer, radiation enteritis, tropical sprue, whipple's disease, lactose
             intolerance, pseudomembranous colitis

          -  Female patients who are pregnant or breastfeeding

          -  Patients who have received an investigational drug within 30 days prior to entering
             the screening phase of the study

          -  Patients with aspartate aminotransferase (AST) or alanine aminotransferase (ALT)
             levels greater than 3 times the upper limit of normal values or elevated uric acid
             levels greater than 1.5 times the upper limit of normal values

          -  Patients with causes for EPI other than CP and partial/total pancreas resection,
             example, cystic fibrosis, primary sclerosing cholangitis, hemochromatosis, isolated
             enzyme deficiency, deficiency in activation of enzymes in the small intestine etc

          -  Patients with a history or clinical evidence of any relevant cardio- or
             cerebrovascular, renal, endocrine, neurologic, infectious, other gastrointestinal,
             hematological, oncological or psychiatric disease or emotional problems, which, in the
             opinion of the investigator, would pose a significant risk for the patient, invalidate
             the giving of informed consent or limit the ability of the patients to comply with
             study requirements or interfere otherwise with the conduct of the study and the same
             applies for immunocompromised patients and/or neutropenic patients
      

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Aptalis Medical Information, , 

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT00559364

Organization ID

VIO16EPI07-01


Responsible Party

Sponsor

Study Sponsor

Forest Laboratories


Study Sponsor

Aptalis Medical Information, Study Director, Forest Laboratories


Verification Date

February 2017