The objectives of this study are to determine the safety and efficacy of IW-9179 administered to patients with functional dyspepsia (FD).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
10
AZ Sint-Lucas Brugge
Bruges, Belgium
Antwerp University Hospital
Edegem, Belgium
Z.O.L. - Campus St. Jan
Genk, Belgium
Rate of treatment-emergent adverse events
Time frame: Reported at any time after the first dose, including the 14 days of treatment and 7 days of follow up
Change from baseline 12-lead electrocardiogram (ECG) at day 14 of treatment
Time frame: Baseline values taken just prior to first dose (day 1) compared with values taken on the last day of treatment (day 14)
Change from baseline clinical laboratory evaluations at the last day of treatment (day 14)
Time frame: Baseline values taken just prior to first dose (day 1) compared with values taken on the last day of treatment (day 14)
Change from baseline vital signs at the day 14 visit and at the end of the study (7 days after the last dose)
Time frame: Baseline values taken prior to first dose (day 1) compared with values taken at the day 14 visit (14 days after first dose) and at the end of the study (21 days after the first dose)
Post-meal Symptom Severity (PMSS) Assessment
Assessments completed at 15 min prior to dose, just prior to dose, and every 15 minutes after the first dose through 240 minutes (4 hours after first dose)
Time frame: Completed at day 1 and day 14 of the Treatment Period
Daily Patient Symptom Severity (PSS) Assessment
Assessments recorded on a daily basis
Time frame: Average of daily assessments for the 2 weeks just prior to the first dose compared to: 1) the average of the 2 week treatment period, 2) the average of the first week of treatment and 3) the average of the second week of treatment
Weekly Symptom Relief (SR) Assessments
Assessments recorded on a weekly basis weekly
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Universitair Ziekenhuis Gent
Ghent, Belgium
UZ Leuven
Leuven, Belgium
CHU Ambroise Pare
Mons, Belgium
H. Hartziekenhuis Roselare-Menen vzw
Roeselare, Belgium
FlevoResearch
Almere Stad, Netherlands
PreCare Trial and Recruitment
Beek, Netherlands
Andromed Breda
Breda, Netherlands
...and 5 more locations
Time frame: Average of week 1 and week 2 prior to treatment compared with the week 1 and week 2 during treatment
Nepean Dyspepsia Index
Time frame: Baseline NDI score (collected just prior to first dose) compared with End of Treatment NDI (collected just prior to last dose)