Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis Clinical Trial
Official title:
A Double-blind, Randomized, Multicenter, Cross-over Study to Compare the Effect of Creon N and Creon® on Fat Digestion in Subjects ≥ 12 Years of Age With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis
maldigestion of dietary macronutrients (pancreas not producing enough enzymes for digestion of fat, sugars and proteins) in Cystic Fibrosis
| Status | Completed |
| Enrollment | 41 |
| Est. completion date | August 2014 |
| Est. primary completion date | August 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 12 Years and older |
| Eligibility |
Inclusion Criteria: - Signed informed consent given by the subject, or the parents, or a legally acceptable representative. If required by the Institutional Review Board/Ethics Committee (IRB/IEC), assent will be given by the subject - Age = 12 years - Subjects who are able to swallow capsules with each meal and snacks - Diagnosis of Cystic Fibrosis (CF) confirmed by two positive chloride sweat tests or gene analysis - Diagnosis of pancreatic exocrine insufficiency proven by: 1. Coefficient of fat absorption (CFA) < 70% without supplementation 2. or Human fecal elastase < 50 µg/g stool - Currently receiving treatment with a commercially available pancreatic enzyme product and on a continuous dose of this product for more than 3 months - Clinically stable condition without evidence of acute respiratory disease within 1 month of enrollment - Stable body weight defined as no more than a 5% decline within 3 months of enrolment - Females of child-bearing potential should agree to continue using a medically acceptable method of birth control throughout the study and for 30 days immediately after the last dose of study drug. Medically acceptable methods of birth control include bilateral tubal ligation or the use of either a contraceptive implant, a contraceptive injection (Depo-Provera™), an intrauterine device, or an oral contraceptive taken within the past 3 months where the subject agrees to continue using during the study or to adopt another birth control method, or a double-barrier method which consists of a combination of any two of the following: diaphragm, cervical cap, condom, or spermicide. Exclusion Criteria: - Evidence of cardiovascular, respiratory, urogenital, gastrointestinal/hepatic (except underlying disease), hematologic/immunologic, head, ears, eyes, nose, throat, dermatologic/connective tissue, musculoskeletal, metabolic/nutritional (except underlying disease), endocrine (except diabetes mellitus), neurologic/psychiatric, allergy, recent major surgery, or other relevant diseases as revealed by history, physical examination and/or laboratory assessments, which could limit participation in or completion of the study - History of acute abdomen - History of fibrosing colonopathy - History of distal intestinal obstruction syndrome (DIOS) within 6 months prior to enrollment - Solid organ transplant or surgery affecting the large bowel other than appendectomy - Small bowel surgery that significantly affected absorptive capacity (e.g. gastrectomy or pancreatectomy) - Pregnancy or lactation - Any type of malignancy involving the digestive tract in the last 5 years - Celiac disease or Crohn's disease - Known allergy to pancreatin or inactive ingredients (excipients) of pancreatin capsules - Suspected non-compliance or non-cooperation - Intake of experimental drugs within 30 days prior to study start - Mental disability or any other lack of fitness, in the Investigator's opinion, to preclude subject's participation in or ability to complete the study - Diagnosis of human immunodeficiency virus in medical history. |
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Hungary | Research facility ID ORG-000826 | Budapest | |
| Hungary | Research facility ID ORG-000816 | Debrecen | |
| Hungary | Research facility ID ORG-000827 | Kaposvár | |
| Hungary | Research facility ID ORG-000825 | Törökbálint | |
| Spain | Research facility ID ORG-000829 | Barcelona | |
| Spain | Research facility ID ORG-000828 | Sevilla | |
| Spain | Research facility ID ORG-000815 | Valencia |
| Lead Sponsor | Collaborator |
|---|---|
| Abbott |
Hungary, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Coefficient of Fat Absorption (CFA) | CFA is calculated from fat intake and fat excretion, according to the formula: CFA (%) = 100 [fat intake - fat excretion] / fat intake | 5 days | No |
| Secondary | Coefficient of Nitrogen Absorption (CNA). | CNA is calculated from nitrogen intake and nitrogen excretion, according to the formula: CNA (%) = 100 [nitrogen intake - nitrogen excretion] / nitrogen intake) | 5 days | No |
| Secondary | Total Fat Excretion | Total amount of fat excreted during the stool collection period in grams. | 5 days | No |
| Secondary | Stool Frequency | Stool frequency is the average of the daily number of stools recorded during the treatment period | 5 days | No |
| Secondary | Percentage of Days With no Flatulence | The percentage of days with no flatulence is calculated from the diary during the treatment period: 100*(number of days with no flatulence/number of days recorded in diary). | 5 days | No |
| Secondary | Percentage of Days With no Abdominal Pain | The percentage of days with no abdominal pain is calculated from the diary during the treatment period: 100*(number of days with no abdominal pain/ number of days recorded in diary). | 5 days | No |
| Secondary | Percentage of Days With Formed/Normal Stools | The percentage of days with formed/normal stools is calculated from the diary during the treatment period: 100*(number of days with formed/normal stools/ number of days recorded in diary). | 5 days | No |