This study is designed to evaluate the safety, tolerability and efficacy of GS500 as a superabsorbent hydrogel for relief of constipation in subjects with functional constipation.
To evaluate the safety, tolerabilityand efficacy of GS500 as a superabsorbent hydrogel for relief of constipation in subjects with functional constipation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
260
Primary Endpoint
Proportion of CSBM Responders defined as subjects with increase of ≥ 1 CSBM from Baseline Run-In during at least 6 of the 8 weeks of the Effectiveness period
Time frame: 8 weeks
Straining score (EoPS)
Time frame: 8 weeks
Constipation severity (self-assessment on 0 to 10 numerical rating scale)
Time frame: 8 weeks
SBM stool consistency (BSFS)
Time frame: 8 weeks
SBM frequency rate (SBMs/week)
Time frame: 8 weeks
CSBM frequency rate (CSBMs/week)
Time frame: 8 weeks
Proportion of subjects with increase of ≥2 CSBMduringat least6 of the 8 weeks of the Effectiveness period
Time frame: 8 weeks
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