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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03450772
Other study ID # PANC3016
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date August 31, 2017
Est. completion date April 30, 2022

Study information

Verified date November 2021
Source Abbott
Contact Suntje Sander, PhD
Phone +495116750
Email suntje.sander@abbott.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This will be an open-label, randomized, multicenter, cross-over study in 60 subjects with PEI delivering data of 60 subjects for Pancreatin Enteric-Coated Capsules 25000 and of 60 subjects for Pancreatin Enteric-Coated Capsules 10000. The study will be conducted in up to 10 sites in China.


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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Creon® 25000
Experimental drug
Creon® 10000
Active comparator

Locations

Country Name City State
China Shanghai Changhai Hospital Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Abbott

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Coefficient of fat absorption 5 days
Secondary fat intake - fat excretion/fat intake x 100 5 days
Secondary stool weight 5 days
Secondary Clinical symptomatology stool frequency, stool consistency, abdominal pain, flatulence 5 days and 24 weeks
Secondary Subject's acceptance of treatment and preference Subject's acceptance of treatment will be judged based on the following scale: very good, good, moderate and unsatisfactory.
Which treatment did you prefer? No difference between treatment 1 and treatment 2 Treatment 1 is better than treatment 2 Treatment 2 is better than treatment 1
5 days and 24 weeks
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