Pilot study to evaluate the efficacy and tolerability of the combined treatment of bisacodyl and simeticone compared with the efficacy and tolerability of the single products in patients suffering from constipation and bloatedness
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Change in bloatedness score on a 4-point-scale
Time frame: baseline, 1 hour after drug administration
Change in bloatedness score on a 4-point-scale
Time frame: baseline, 2 hours, 3 hours, at time of defecation
Time to defecation
Time frame: up to 7 days
Number of withdrawals due to inadequate efficiency
Time frame: up to 7 days
Patient's global assessment of efficacy on a 4-point-scale
Time frame: up to 7 days
Number of patients with adverse events
Time frame: up to 7 days
Number of patients with abnormal laboratory findings
Time frame: up to 7 days
Number of withdrawals due to safety reasons
Time frame: up to 7 days
Patient's assessment of overall tolerability on a 4-point-scale
Time frame: up to 7 days
Investigator's assessment of overall tolerability on a 4-point-scale
Time frame: up to 7 days
Number of patients with clinically significant changes in vital signs
Time frame: up to 7 days
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