- A multi center Phase IV study.
- 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 also to be evaluated.
- 368 randomized patients aged 18 years and older.
- Recruitment period – 2 years.
- Study duration – 19 months.
- Sites and participating countries – 32 in UK only, conducted in a Phase I unit, GP sites and SMO sites which also recruited additional patients.