Sodium Picosulphate vs. Placebo in Functional Constipation

NCT ID: NCT00576810

Last Updated: 2014-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 367 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31

Brief Summary

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

Conditions

Constipation

Study Design

• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT

Interventions

sodium picosulphate

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Male and female patients, aged 18 and above

2. 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.

1. Must include 2 or more of the following:

• straining during at least 25% of the defecations
• lumpy or hard stools in at least 25% of the defecations
• sensation of incomplete evacuation for at least 25% of the defecations
• sensation of anorectal obstruction/blockade for at least 25% of the defecations
• manual manoeuvres to facilitate at least 25% of the defecations (e.g. digital evacuation, support of the pelvic floor)
• fewer than 3 defecations per week

2. Loose stools are rarely present without the use of laxatives

3. 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)

3. Able and willing to complete a daily e-diary

4. Able and willing to use the trial rescue medication (i.e. 10 mg bisacodyl suppositories)

5. Signed and dated written informed consent prior to enrolment into the study in accordance with GCP and local legislation

Exclusion Criteria

1. Eating disorders such as anorexia nervosa and bulimia, as a cause of excessive use of laxatives

2. Patients whose constipation is caused by primary organic disease of the colon or pelvic floor

3. Patients with metabolic disorders, neurological disorders, severe or psychiatric disorders, or any other significant disease or intercurrent illness (e.g. abdominal/gastrointestinal surgery) that, in the Investigators opinion, would interfere with participation in the trial

4. Patients with restricted mobility (e.g. wheelchair bound, or bed-ridden) that, in the Investigators opinion, would interfere with participation in the trial

5. Patients with a known hypersensitivity to sodium picosulphate, bisacodyl or any other ingredient in the study medication (sodium picosulphate and matching placebo drops, bisacodyl suppositories)

6. Patients with ileus, intestinal obstruction, acute surgical abdominal conditions (such as acute appendicitis and acute inflammatory bowel diseases), or severe dehydration

7. Patients with anal fissures or ulcerative proctitis with mucosal damage

8. Patients with known clinically significant abnormal electrolyte values

9. Patients whose concomitant therapy includes an opioid medication (e.g. morphine, codeine)

10. Constipation which, in the Investigators opinion, is caused by medication (e.g. anticholinergics)

11. Patients who are not willing to discontinue the use of prohibited concomitant therapy (see Section 4.2.2)

12. Pre-menopausal women (last menstruation £ 1 year prior to signing informed consent) who:are nursing (breast-feeding) or who are pregnant OR who are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study.

13. Participating in another trial with an investigational product with 1 month of enrolment into this study

14. Drug or alcohol abuse

15. Concomitant use of antibiotics

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Boehringer Ingelheim

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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

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

Countries

Germany

Other Identifiers

EURDRACT2007-002087-10

Identifier Type: -

Identifier Source: secondary_id

1062.7

Identifier Type: -

Identifier Source: org_study_id