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Sponsored by: |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
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Information provided by: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
ClinicalTrials.gov Identifier: | NCT00662675 |
The purpose of this study is to assess the effectiveness and safety of oral pancrelipase MT in the treatment of adult and pediatric/adolescent cystic fibrosis (CF) patients with clinical symptoms of exocrine pancreatic insufficiency (EPI).
Condition | Intervention | Phase |
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Cystic Fibrosis Exocrine Pancreatic Insufficiency Malabsorption Syndromes Steatorrhea |
Drug: Pancrease MT 10, or MT 20 Drug: Placebo for Pancrease MT 10 or MT 20 |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized Double-Blind (Withdrawal) Phase 3 Study to Evaluate the Efficacy and Tolerability of Pancrelipase MT Capsules Compared With Placebo in the Treatment of Subjects With Cystic Fibrosis-Dependent Exocrine Pancreatic Insufficiency |
Enrollment: | 40 |
Study Start Date: | June 2008 |
Study Completion Date: | December 2008 |
Arms | Assigned Interventions |
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001: Experimental |
Drug: Pancrease MT 10, or MT 20
Pancrease MT capsules for maximun dose of 10,000 units / Kg / day
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002: Placebo Comparator |
Drug: Placebo for Pancrease MT 10 or MT 20
Capsules with Pancrease MT excipients without the active enzymes
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This is a randomized, placebo-controlled, double-blind withdrawal, multicenter study to evaluate the effectiveness of pancrelipase MT capsules compared with placebo in the treatment of adult (>18 to 60 years of age) and pediatric/adolescent (7 to 18 years of age) patients with CF and who require pancreatic enzyme replacement therapy (PERT) to control clinical symptoms of EPI and steatorrhea (excess fat in the feces). The study has 3 phases: a screening phase, an open-label (run-in) phase, and a double-blind withdrawal phase. The study including the screening phase will be approximately 21 days in length. In the screening phase, patients will begin a high-fat diet and will take pancrelipase MT10 or MT20 capsules (or a combination of both) orally with meals (or snacks) to optimize digestion based on clinical signs and symptoms. In the open-label phase patients will continue taking their optimal dose of study drug. After a minimum of 3 days in the open-label treatment phase, an inpatient 72-hour stool collection period for fecal fat determination will be performed. Patients with a coefficient of fat absorption (COA)-fat of 80% or greater who have completed at least 6 days on a controlled high-fat diet will be eligible for the double-blind withdrawal phase of the study and will be randomly assigned to receive placebo or pancrelipase MT. After a minimum of 1 day on double-blind treatment and with the presence of deteriorating clinical signs and symptoms, patients will be admitted to the clinic to begin a second 72-hour inpatient stool collection period. Effectiveness evaluations will be performed throughout the study and consist of stool collection for determination of COA-fat and coefficient of protein absorption (COA-protein), stool diary, nutrition worksheet, and Clinical Global Impression-Severity of illness (CGI-S), Clinical Global Impression-Change (CGI-C), and Global Assessment of Change (GAC) scales. Signs and symptoms exhibited during the study will be monitored and will include the presence or absence of diarrhea, abdominal pain, nausea, vomiting, bloating, and a description of stool changes. The study hypothesis is that the study drug will be more effective than placebo as measured by the change in the coefficient of fat absorption (COA-fat) in adults and pediatric/adolescent patients with EPI secondary to CF.
Pancrelipase MT10 or MT20 capsules (or a combination of both) will be taken orally with meals (or snacks) within the recommended ranges of pancreatic enzyme therapy as recommended by the CF Foundation and up to a maximum 10,000 units lipase per kilogram [kg] per day. All patients will take pancrelipase MT for 6 days in the screening phase and for approximately 6 to 10 days in the open-label phase; patients will take pancrelipase MT or placebo for 4 to 7 days in the double-blind phase.
Ages Eligible for Study: | 7 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
Responsible Party: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. ( Senior Director, Compound Development Leader ) |
Study ID Numbers: | CR014719 |
Study First Received: | April 17, 2008 |
Last Updated: | March 26, 2009 |
ClinicalTrials.gov Identifier: | NCT00662675 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Adult Exocrine pancreatic insufficiency Pediatrics Cystic fibrosis |
Malabsorption syndromes Pancrelipase Steatorrhea |
Metabolic Diseases Fibrosis Gastrointestinal Diseases Intestinal Diseases Pancrelipase Digestive System Diseases Cystic Fibrosis Respiratory Tract Diseases |
Genetic Diseases, Inborn Lung Diseases Malabsorption Syndromes Pancreatic Diseases Infant, Newborn, Diseases Metabolic Disorder Exocrine Pancreatic Insufficiency Steatorrhea |
Disease Metabolic Diseases Gastrointestinal Diseases Fibrosis Gastrointestinal Agents Intestinal Diseases Pancrelipase Pharmacologic Actions Digestive System Diseases Pathologic Processes Cystic Fibrosis |
Respiratory Tract Diseases Genetic Diseases, Inborn Therapeutic Uses Syndrome Lung Diseases Malabsorption Syndromes Pancreatic Diseases Infant, Newborn, Diseases Exocrine Pancreatic Insufficiency Steatorrhea |