A Study of the Efficacy and Tolerability of Pancrelipase Microtablet (MT) Capsules for the Treatment of Cystic Fibrosis-dependent Exocrine Pancreatic Insufficiency
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ClinicalTrials.gov Identifier: NCT00662675 |
Recruitment Status :
Completed
First Posted : April 21, 2008
Results First Posted : March 17, 2010
Last Update Posted : May 9, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Exocrine Pancreatic Insufficiency Steatorrhea Malabsorption Syndromes Cystic Fibrosis | Drug: Pancrease MT 10.5, or MT 21 Drug: Placebo for Pancrease MT 10.5 or MT 21 | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 40 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | August 2008 |
Actual Primary Completion Date : | February 2009 |
Actual Study Completion Date : | February 2009 |

Arm | Intervention/treatment |
---|---|
Experimental: 001
Pancrease MT 10.5 or MT 21 Pancrease MT capsules for maximum dose of 10 000 lipase units / Kg / day
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Drug: Pancrease MT 10.5, or MT 21
Pancrease MT capsules for maximum dose of 10,000 lipase units / Kg / day |
Experimental: 002
Placebo for Pancrease MT 10.5 or MT 21 Capsules with Pancrease MT excipients without the active enzymes
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Drug: Placebo for Pancrease MT 10.5 or MT 21
Capsules with Pancrease MT excipients without the active enzymes |
- Change in the Coefficient of Fat Absorption (COA-fat Percent) [ Time Frame: 72-hours stool collection in the open-label phase to the end of 72-hours stool collection in the double-blind withdrawal phase. ]Change in the coefficient of fat absorption (percent COA-fat) from the 72-hour inpatient period in the open-label phase to the 72-hour period inpatient period in the double-blind (withdrawal) phase.
- Change in Percent COA-Protein (Nitrogen) [ Time Frame: 72-hours stool collection in the open-label phase to the end of 72-hours stool collection in the double-blind withdrawal phase. ]The change in percent COA-protein from the stool collection period in double-blind phase to open-label phase
- Percent of Patients Reporting Clinical Signs and Symptoms of Exocrine Pancreatic Insufficiency (EPI) During the Double-Blind Phase [ Time Frame: Entire 7 days double-blind phase ]Percent of patients reporting nausea, vomiting, bloating, diarrhea, oily/greasy stools, and abdominal pain signs and symptoms reported as Adverse events during the double-blind phase.

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Ages Eligible for Study: | 7 Years to 60 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Have a diagnosis of CF documented by sweat chloride results (>60 mmol/L) and require pancreatic enzyme replacement therapy (PERT) to control clinical symptoms of EPI (nausea, vomiting, bloating, diarrhea, and abdominal pain) with a history of excess fat in the feces
- Have documentation of an abnormal COA-fat and a fecal elastase result of <100 micrograms fecal elastase/gram stool
- Must be on a stable diet and dose of pancreatic enzyme supplementation that has provided satisfactory symptom control for at least the past 1 month
Exclusion Criteria:
- No extreme physical wasting with loss of weight and muscle mass
- No severe, acute, or chronic pulmonary disease unrelated to complications of CF
- No worsening of pulmonary disease in past 30 days
- No use of drugs known to affect blood uric acid concentrations (e.g., aspirin, diflunisal, allopurinol, probenecid, thiazide diuretics, phenylbutazone, sulfinpyrazone)
- No known congenital (present at birth) abnormalities of the gastrointestinal tract, heart, or liver
- No distal intestinal obstruction syndrome (DIOS)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00662675
United States, California | |
Long Beach, California, United States | |
Los Angeles, California, United States | |
United States, Florida | |
Orlando, Florida, United States | |
United States, Kentucky | |
Louisville, Kentucky, United States | |
United States, Nevada | |
Las Vegas, Nevada, United States | |
United States, New Jersey | |
Long Branch, New Jersey, United States | |
United States, Ohio | |
Cincinnati, Ohio, United States | |
Cleveland, Ohio, United States | |
United States, Oklahoma | |
Oklahoma City, Oklahoma, United States | |
United States, Pennsylvania | |
Pittsburgh, Pennsylvania, United States | |
Canada, British Columbia | |
Vancouver N/A, British Columbia, Canada |
Study Director: | Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
Responsible Party: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
ClinicalTrials.gov Identifier: | NCT00662675 |
Other Study ID Numbers: |
CR014719 |
First Posted: | April 21, 2008 Key Record Dates |
Results First Posted: | March 17, 2010 |
Last Update Posted: | May 9, 2014 |
Last Verified: | April 2014 |
Exocrine pancreatic insufficiency Steatorrhea Malabsorption syndromes Cystic fibrosis |
Pediatrics Adult Pancrelipase |
Cystic Fibrosis Exocrine Pancreatic Insufficiency Malabsorption Syndromes Steatorrhea Fibrosis Pathologic Processes Pancreatic Diseases Digestive System Diseases Lung Diseases |
Respiratory Tract Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Intestinal Diseases Gastrointestinal Diseases Metabolic Diseases Pancrelipase Pancreatin Gastrointestinal Agents |