Conditions: Constipation
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 368
Healthy volunteers: no

Brief summary:
The objective of the study was to compare the efficacy and safety of 4 weeks treatment with bisacodyl (Dulcolax) tablets 10 mg to placebo in patients with functional constipation. In addition, the effect of treatment on quality of life and general health status was evaluated.

Detailed description:

Arms:
arm 1: patient to receive two enteric-coated tablets containing 5 mg bisacodyl arm 2: patient to receive two placebo-to-match enteric-coated tablets 5 mg bisacodyl

Interventions: intervention 1: Bisacodyl 10 mg intervention 2: Placebo
Intervention descriptions: intervention 1: 2 x 5 mg bisacodyl once daily intervention 2: Placebo-to-match bisacodyl 10 mg (2 x 5 mg) once daily

Protocol document: