Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials!!

Clinical Trial 4104

Oklahoma City, OK 73119


Study Summary:

Diseases that result in significant reduction of exocrine pancreatic enzyme secretions, such as cystic fibrosis, chronic pancreatitis, or ductal obstruction due to neoplasm, or surgery such as pancreatectomy and gastrointestinal bypass, disrupt the normal digestion of nutrients. The immediate consequences of an absence of the digestive enzymes lipase, protease, and amylase are steatorrhea and creatorrhea and abdominal symptoms such as distension, diarrhea, and cramping. In the longer term, malnutrition occurs due to the significantly impaired absorption of fat, protein, and carbohydrate. The increase of mean survival in patients with cystic fibrosis from 3 years to over 32 years today is due at least in part to the development of enteric-coated exocrine pancreatic enzyme products. The improved nutritional status has additionally been reported to improve the pulmonary function of these patients. The benefits of treatment of pancreatic insufficiency with appropriately formulated pancreatic enzymes are clearly advantageous for contributing to the maintenance of normal growth parameters, micronutrient and macronutrient requirements of infants, children, and adult patients with cystic fibrosis. In the United States, PANCREASE® MT is indicated for the treatment of steatorrhea secondary to pancreatic insufficiency in disorders such as cystic fibrosis or chronic alcoholic pancreatitis


Qualified Participants Must:

• Man or women/boy or girl
• Adults >18 to 60 years of age
• or, pediatric/adolescents 7 to 18 years of Age
• Have a diagnosis of CF documented by sweat chloride results (>60 mmol/L) and require PERT to control clinical symptoms of EPI (nausea, vomiting, bloating, diarrhea, and abdominal pain) with a history of steatorrhea
• Historical documentation of an abnormal COA-fat and a fecal elastase result of <100 µg fecal elastase/gram stool consistent with diagnosis of CF-related PI
• Historical documentation within 2 months of screening or fasting breath hydrogen <15 parts per million on Day 1 of the screening period, results must not be consistent with small bowel overgrowth
• Are receiving a stable diet and dose of pancreatic enzyme supplementation that has provided satisfactory symptom control for at least 1 month before screening for this study
• Subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study. Assent is also required of children capable of understanding the nature of the study (typically 7 years of age and older) as described in Section 15.2.3, Informed Consent
• Willing to adhere to the prohibitions and restrictions specified in this Protocol
• Medically stable on the basis of the physical examination, medical history, and vital signs, performed at screening. If there are abnormalities, they must be consistent with the underlying illness in the study population
• Females of childbearing potential must have a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test at the screening visit
• If using gastrointestinal medications or medications affecting the gastrointestinal tract other than oral pancreatic enzymes including: acid blockers, H2 antagonists, and proton pump inhibitors, must have maintained a stable dose of these medications for at least 30 days before the screening period and agree to maintain that dose and the timing and mode of administration throughout the study. New treatment with these medications cannot be started during the study.


Qualified Participants May Receive:

*A subject stipend for the Study subjects in the amount of $170.00 USD has been included in the cost associated with each scheduled visit, and has been incorporated into the payment for each visit listed on the payment schedule, above. This allowance is intended to offset the Study subject’s costs associated with overnight visits, where appropriate, incurred as a result of Study participation, and shall be reflected in the Informed Consent Form, as it will be provided to the Study subject.

*A subject stipend for the Study subjects in the amount of $40.00 USD has been included in the cost associated with each scheduled visit, and has been incorporated into the payment for each visit listed on the payment schedule, above. This allowance is intended to offset the Study subject’s costs associated with travel expenses and meals, where appropriate, incurred as a result of Study participation, and shall be reflected in the Informed Consent Form, as it will be provided to the Study subject.


Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.