This study will provide efficacy data for Creon 40,000 in CP subjects as well as long-term safety data. During the long-term treatment with Creon 40,000 nutritional parameters will be assessed and correlated with CFA.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
62
Pancreatin with 40000 lipase units per capsule, 2 capsules per main meal (3 main meals) plus 1 capsule per snack (2-3 snacks)
placebo
Site Reference ID/Investigator# 45389
Bangalore, India
Site Reference ID/Investigator# 45396
Bhopal, India
Site Reference ID/Investigator# 45390
Chennai, India
Change in CFA from baseline to the end of double blind treatment
Time frame: 7 days after baseline
CNA, stool fat, stool weight, nutritional, clinical symptomatology, SF-36, BMI
Time frame: 7 days after baseline, and end of open-label period (1 year of open label treatment)
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Site Reference ID/Investigator# 45391
Hyderabad, India
Site Reference ID/Investigator# 45388
Jaipur, India
Site Reference ID/Investigator# 54382
Kochi, India
Site Reference ID/Investigator# 45387
Kolkata, India
Site Reference ID/Investigator# 45383
Mumbai, India
Site Reference ID/Investigator# 45382
Pune, India
Site Reference ID/Investigator# 45395
Pune, India
...and 1 more locations