The objective ot the study is to compare the efficacy and safety of 4 weeks treatment with sodium picosulphate drops 10mg to placebo in patients with functional constipation. In addition the effect of treatment on quality of life and general health status will be evaluated
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Enrollment
367
The primary endpoint in this trial is the mean number of complete spontaneous bowel movements (CSBMs) per week, during the 4 week treatment phase of the trial.
Time frame: 4 weeks
Number of CSBMs per week, at each weekly time point during the treatment phase of the trial (i.e. at each of weeks 1, 2, 3 and 4)
Time frame: 4 weeks
Number of spontaneous bowel movements (SBMs) per week after the first intake of the study medication
Time frame: 4 weeks
Time to first SBM following the first intake of the study medication
Time frame: 4 weeks
Number of patients with an increase of ≥ 1 CSBM per week compared with the last 7 days of the baseline period
Time frame: 4 weeks
Number of patients with ≥ 1 CSBM a day
Time frame: 4 weeks
Number of patients with ≥ 3 CSBMs per week
Time frame: 4 weeks
Number of premature withdrawals
Time frame: 4 weeks
Number of patients who have used rescue medication
Time frame: 4 weeks
Change from baseline in mean score per week for constipation symptoms
Time frame: 4 weeks
Change from baseline in the patients' score per week for overall satisfaction with bowel habits and bothersomeness of constipation symptoms
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1062.7.4926 Boehringer Ingelheim Investigational Site
Amberg, Germany
1062.7.4918 Boehringer Ingelheim Investigational Site
Bad Essen, Germany
1062.7.4946 Boehringer Ingelheim Investigational Site
Bergkamen, Germany
1062.7.4904 Boehringer Ingelheim Investigational Site
Berlin, Germany
1062.7.4929 Boehringer Ingelheim Investigational Site
Berlin, Germany
1062.7.4902 Boehringer Ingelheim Investigational Site
Blankenhain, Germany
1062.7.4927 Boehringer Ingelheim Investigational Site
Dortmund, Germany
1062.7.4954 Boehringer Ingelheim Investigational Site
Dortmund, Germany
1062.7.4949 Boehringer Ingelheim Investigational Site
Dresden, Germany
1062.7.4950 Boehringer Ingelheim Investigational Site
Einbeck, Germany
...and 33 more locations
Time frame: 4 weeks
Final global assessment of efficacy by the investigator (good, satisfactory, not satisfactory, bad)
Time frame: 4 weeks
Final global assessment of efficacy by the patient (good, satisfactory, not satisfactory, bad)
Time frame: 4 weeks
Quality of Life (SF-36v2and PAC-QOL)
Time frame: 4 weeks
Blood pressure
Time frame: 4 weeks
Number of participants with abnormal serum electrolyte laboratory parameters
Time frame: 4 weeks
Number of participants with abnormal serum chemistry laboratory parameters
Time frame: 4 weeks
Final global assessment of tolerability by the investigator (good, satisfactory, not satisfactory, bad)
Time frame: 4 weeks
Final global assessment of tolerability by the patient (good, satisfactory, not satisfactory, bad)
Time frame: 4 weeks