An open label, exploratory study on the effect of rhBSSL on the fat absorption in patients with cystic fibrosis and pancreatic insufficiency. - N/A

• Conditions: Cystic fibrosis and pancreatic insufficiency; MedDRA version: 9.1Level: LLTClassification code 10011762Term: Cystic fibrosis

• Registration Number: EUCTR2007-004063-21-NL
• Lead Sponsor: Biovitrum AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10-31
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

1. Male and female patients age = 18 years.
2. Women of childbearing potential must use proper methods of birth control during study, mechanical or hormonal.
3. Clinically diagnosed CF established by sweat test or positive genotyping for two disease causing CF mutations of class I and II transmembrane conductance regulator (CFTR).
4. Documented PI by fecal elastase-1 monoclonal test <100 µg/g.
5. Able to refrain from their ongoing pancreatic enzyme treatment for a period of 7 days.
6. Able to produce stools = 5 times per week.
7. Able to give signed written informed consent to participate in this study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Women who are pregnant or breast feeding.
2. Short bowel or other complications related to previous gastrointestinal (GI) surgery.
3. Continuous enteric feeding by PEG or by enteral tube.
4. Intravenous nutrition within two weeks before inclusion in the study.
5. Acute antibiotic treatment within two weeks of inclusion in study (maintenance antibiotic treatment allowed).
6. Known Distal Intestinal Obstructive Syndrome (DIOS).
7. Treatment with prokinetics during the course of the study.
8. Any intake of alcohol 10 hours prior to screening.
9. Unstable diabetes.
10. FEV1 < 40%, and/or unstable lung disease, such as recent exacerbations, within last 4 months.
11. Unwilling/unable to switch to esomeprazole 40 mg over the specified baseline and treatment periods.
12. Taking any drug incompatible with esomeprazole.
13. Liver failure.
14. Severe malnutrition defined as BMI < 18.
15. Any previous allergy to the investigational product and/or associated products.
16. Known history of hypersensitivity or intolerance to omeprazol or esomeprazole.
17. Known alcohol abuse.
18. On the waiting list for, or previously had lung transplantation.
19. Participation in another therapeutic clinical trial less than four weeks before inclusion in the study.
20. Not able or willing to comply with the study requirements for the duration of the study.
21. Any condition which in the opinion of the investigator makes the patient unsuitable for inclusion.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified