A proof-of-concept, dose finding, controlled, single-center, randomized, double-blind, fixed dose phase 2 trial with ZP1848 in patients with Short Bowel Syndrome.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
18
Rigshospitalet
Copenhagen, Denmark
The Primary endpoint is the absolute change from baseline to the end of three week treatment periods of wet weight of ostomy output or diarrhea measured separately over each of the two treatment periods.
Time frame: 3 weeks
Relative change from baseline to the end of treatment of wet weight of ostomy output or diarrhea measured separately over each of the two treatment periods
Time frame: 3 weeks
Absolute change from baseline to the end of treatment of urine weight measured separately over each of the two treatment periods
Time frame: 3 weeks
Relative change from baseline to the end of treatment of urine weight measured separately over each of the two treatment periods
Time frame: 3 weeks
Absolute change from baseline to the end of treatment of wet weight absorption measured separately over each of the two treatment periods
Time frame: 3 weeks
Relative change from baseline to the end of treatment of wet weight absorption measured separately over each of the two treatment periods
Time frame: 3 weeks
Absolute change from baseline to the end of treatment of the intestinal absorption of electrolytes measured separately over each of the two treatment periods
Time frame: 3 weeks
Relative change from baseline to the end of treatment of the intestinal absorption of electrolytes measured separately over each of the two treatment periods
Time frame: 3 weeks
Absolute change from baseline to the end of treatment of the intestinal absorption of macronutrients measured separately over each of the two treatment periods
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Time frame: 3 weeks
Relative change from baseline to the end of treatment of the intestinal absorption of macronutrients measured separately over each of the two treatment periods
Time frame: 3 weeks
Change in SF-36 score
Time frame: 3 weeks
Incidence of Adverse Events
Time frame: 15 weeks
Incidence of Anti Drug Antibodies
Time frame: 15 weeks
Absolute change from baseline to the end of treatment of urine weight minus oral intake measured separately over each of the two treatment periods
Time frame: 3 weeks
Relative change from baseline to the end of treatment of urine weight minus oral intake measured separately over each of the two treatment periods
Time frame: 3 weeks