Clinical trial: A Study of the Efficacy and Tolerability of Pancrelipase Microtablet (MT) Capsules for the Treatment of Cystic Fibrosis-dependent Exocrine Pancreatic Insufficiency (NCT00662675)

Eligibility criteria:
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)
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 7 Years old.
Subject must be at most 60 Years

Patient description (medical language): A 30-year-old man who is a computer scientist came to the clinic with the lab result stating azoospermia.  The patient is sexually active with his wife and does not use any contraception methods.  They have been trying to conceive for the past year with no success.  The patient has a past medical history of recurrent pneumonia, shortness of breath, and  persistent cough that produces large amounts of thick sputum. The patient had multiple lung infections during childhood. He does not smoke, use illicit drugs or alcohol.  The patient has no history of other medical conditions including allergies or any kind of surgery.  On physical examination, the digits show clubbing.  An ultrasound shows bilateral absence of the vas deferens, and FEV1 was 75% on the respiratory function test.

Patient description (patient's own words): I'm a 30-year-old computer scientist. I did some lab tests that came back quite alarming, stating that I have azoospermia?! I'm sexually active with my wife and we don't use contraception. We've been trying to have a child for the past year. I have a medical history of pneumonia and shortness of breath and regular wet cough. I had several lung infections when I was a kid. That's why I'm very careful and don't smoke, do drugs, or drink. I don't have other medical conditions including allergies or any kind of surgery. The doctor did the clubbing test on my fingers, which was positive. I also did an ultrasound and it showed that I'm missing the tubes that carry sperm around. I also had a 75% for my respiratory function test.

Does the patient match the trial criteria? 0