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| ID | Type | Description | Link |
|---|---|---|---|
| EURDRACT2007-002087-10 |
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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
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sodium picosulphate | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 4 weeks | |
| Number of spontaneous bowel movements (SBMs) per week after the first intake of the study medication | 4 weeks |
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Inclusion Criteria:
Male and female patients, aged 18 and above
Suffering from functional constipation, according to their medical history, as defined by the Rome III diagnostic criteria Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis.
Must include 2 or more of the following:
Loose stools are rarely present without the use of laxatives
There are insufficient criteria for irritable bowel syndrome (IBS) (i.e. recurrent abdominal pain or discomfort is not the predominant symptom associated with defecation or a change in bowel habit, and with features of disordered defecation)
Able and willing to complete a daily e-diary
Able and willing to use the trial rescue medication (i.e. 10 mg bisacodyl suppositories)
Signed and dated written informed consent prior to enrolment into the study in accordance with GCP and local legislation
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1062.7.4926 Boehringer Ingelheim Investigational Site | Amberg | Germany | ||||
| 1062.7.4918 Boehringer Ingelheim Investigational Site |
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| Time to first SBM following the first intake of the study medication | 4 weeks |
| Number of patients with an increase of ≥ 1 CSBM per week compared with the last 7 days of the baseline period | 4 weeks |
| Number of patients with ≥ 1 CSBM a day | 4 weeks |
| Number of patients with ≥ 3 CSBMs per week | 4 weeks |
| Number of premature withdrawals | 4 weeks |
| Number of patients who have used rescue medication | 4 weeks |
| Change from baseline in mean score per week for constipation symptoms | 4 weeks |
| Change from baseline in the patients' score per week for overall satisfaction with bowel habits and bothersomeness of constipation symptoms | 4 weeks |
| Final global assessment of efficacy by the investigator (good, satisfactory, not satisfactory, bad) | 4 weeks |
| Final global assessment of efficacy by the patient (good, satisfactory, not satisfactory, bad) | 4 weeks |
| Quality of Life (SF-36v2and PAC-QOL) | 4 weeks |
| Blood pressure | 4 weeks |
| Number of participants with abnormal serum electrolyte laboratory parameters | 4 weeks |
| Number of participants with abnormal serum chemistry laboratory parameters | 4 weeks |
| Final global assessment of tolerability by the investigator (good, satisfactory, not satisfactory, bad) | 4 weeks |
| Final global assessment of tolerability by the patient (good, satisfactory, not satisfactory, bad) | 4 weeks |
| 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 |
| 1062.7.4909 Boehringer Ingelheim Investigational Site | Freising | Germany |
| 1062.7.4923 Boehringer Ingelheim Investigational Site | Fürth | Germany |
| 1062.7.4912 Boehringer Ingelheim Investigational Site | Hagen | Germany |
| 1062.7.4953 Boehringer Ingelheim Investigational Site | Hamburg | Germany |
| 1062.7.4910 Boehringer Ingelheim Investigational Site | Hanover | Germany |
| 1062.7.4920 Boehringer Ingelheim Investigational Site | Herne | Germany |
| 1062.7.4944 Boehringer Ingelheim Investigational Site | Ingelheim | Germany |
| 1062.7.4936 Boehringer Ingelheim Investigational Site | Jena | Germany |
| 1062.7.4925 Boehringer Ingelheim Investigational Site | Leipzig | Germany |
| 1062.7.4931 Boehringer Ingelheim Investigational Site | Leipzig | Germany |
| 1062.7.4907 Boehringer Ingelheim Investigational Site | Leverkusen | Germany |
| 1062.7.4942 Boehringer Ingelheim Investigational Site | Ludwigsburg | Germany |
| 1062.7.4906 Boehringer Ingelheim Investigational Site | Ludwigsfelde | Germany |
| 1062.7.4941 Boehringer Ingelheim Investigational Site | Ludwigshafen | Germany |
| 1062.7.4922 Boehringer Ingelheim Investigational Site | Lüdenscheid | Germany |
| 1062.7.4930 Boehringer Ingelheim Investigational Site | Lüdenscheid | Germany |
| 1062.7.4911 Boehringer Ingelheim Investigational Site | Lützen | Germany |
| 1062.7.4916 Boehringer Ingelheim Investigational Site | Marburg | Germany |
| 1062.7.4948 Boehringer Ingelheim Investigational Site | Marl | Germany |
| 1062.7.4921 Boehringer Ingelheim Investigational Site | Oelde | Germany |
| 1062.7.4935 Boehringer Ingelheim Investigational Site | Offenbach | Germany |
| 1062.7.4903 Boehringer Ingelheim Investigational Site | Potsdam | Germany |
| 1062.7.4937 Boehringer Ingelheim Investigational Site | Recklinghausen | Germany |
| 1062.7.4956 Boehringer Ingelheim Investigational Site | Reichenbach | Germany |
| 1062.7.4905 Boehringer Ingelheim Investigational Site | Saarbrücken | Germany |
| 1062.7.4933 Boehringer Ingelheim Investigational Site | Salzkotten | Germany |
| 1062.7.4943 Boehringer Ingelheim Investigational Site | Stendal | Germany |
| 1062.7.4955 Boehringer Ingelheim Investigational Site | Stuhr | Germany |
| 1062.7.4957 Boehringer Ingelheim Investigational Site | Thedinghausen | Germany |
| 1062.7.4913 Boehringer Ingelheim Investigational Site | Wallerfing | Germany |
| 1062.7.4924 Boehringer Ingelheim Investigational Site | Wardenburg | Germany |
| 1062.7.4914 Boehringer Ingelheim Investigational Site | Wiesbaden | Germany |
| 1062.7.4901 Boehringer Ingelheim Investigational Site | Winsen | Germany |
| ID | Term |
|---|---|
| D003248 | Constipation |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C005701 | picosulfate sodium |
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