Clinical trial NCT00576810: Sodium Picosulphate vs. Placebo in Functional Constipation
Official title: A Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy and Safety of 4 Weeks Treatment With Sodium Picosulfate [Dulcolax®, Laxoberal®]Drops 10 mg Administered Orally, Once Daily, in Patients With Functional Constipation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Constipation
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2007-12-19
Enrollment: 367
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: 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.
timeFrame: 4 weeks
Secondary outcomes:
measure: 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)
timeFrame: 4 weeks
measure: Number of spontaneous bowel movements (SBMs) per week after the first intake of the study medication
timeFrame: 4 weeks
measure: Time to first SBM following the first intake of the study medication
timeFrame: 4 weeks
measure: Number of patients with an increase of ≥ 1 CSBM per week compared with the last 7 days of the baseline period
timeFrame: 4 weeks
measure: Number of patients with ≥ 1 CSBM a day
timeFrame: 4 weeks
measure: Number of patients with ≥ 3 CSBMs per week
timeFrame: 4 weeks
measure: Number of premature withdrawals
timeFrame: 4 weeks
measure: Number of patients who have used rescue medication
timeFrame: 4 weeks
measure: Change from baseline in mean score per week for constipation symptoms
timeFrame: 4 weeks
measure: Change from baseline in the patients' score per week for overall satisfaction with bowel habits and bothersomeness of constipation symptoms
timeFrame: 4 weeks
measure: Final global assessment of efficacy by the investigator (good, satisfactory, not satisfactory, bad)
timeFrame: 4 weeks
measure: Final global assessment of efficacy by the patient (good, satisfactory, not satisfactory, bad)
timeFrame: 4 weeks
measure: Quality of Life (SF-36v2and PAC-QOL)
timeFrame: 4 weeks
measure: Blood pressure
timeFrame: 4 weeks
measure: Number of participants with abnormal serum electrolyte laboratory parameters
timeFrame: 4 weeks
measure: Number of participants with abnormal serum chemistry laboratory parameters
timeFrame: 4 weeks
measure: Final global assessment of tolerability by the investigator (good, satisfactory, not satisfactory, bad)
timeFrame: 4 weeks
measure: Final global assessment of tolerability by the patient (good, satisfactory, not satisfactory, bad)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Amberg
country: Germany
facility: 1062.7.4926 Boehringer Ingelheim Investigational Site
city: Bad Essen
country: Germany
facility: 1062.7.4918 Boehringer Ingelheim Investigational Site
city: Bergkamen
country: Germany
facility: 1062.7.4946 Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: 1062.7.4904 Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: 1062.7.4929 Boehringer Ingelheim Investigational Site
city: Blankenhain
country: Germany
facility: 1062.7.4902 Boehringer Ingelheim Investigational Site
city: Dortmund
country: Germany
facility: 1062.7.4927 Boehringer Ingelheim Investigational Site
city: Dortmund
country: Germany
facility: 1062.7.4954 Boehringer Ingelheim Investigational Site
city: Dresden
country: Germany
facility: 1062.7.4949 Boehringer Ingelheim Investigational Site
city: Einbeck
country: Germany
facility: 1062.7.4950 Boehringer Ingelheim Investigational Site
city: Freising
country: Germany
facility: 1062.7.4909 Boehringer Ingelheim Investigational Site
city: Fürth
country: Germany
facility: 1062.7.4923 Boehringer Ingelheim Investigational Site
city: Hagen
country: Germany
facility: 1062.7.4912 Boehringer Ingelheim Investigational Site
city: Hamburg
country: Germany
facility: 1062.7.4953 Boehringer Ingelheim Investigational Site
city: Hannover
country: Germany
facility: 1062.7.4910 Boehringer Ingelheim Investigational Site
city: Herne
country: Germany
facility: 1062.7.4920 Boehringer Ingelheim Investigational Site
city: Ingelheim
country: Germany
facility: 1062.7.4944 Boehringer Ingelheim Investigational Site
city: Jena
country: Germany
facility: 1062.7.4936 Boehringer Ingelheim Investigational Site
city: Leipzig
country: Germany
facility: 1062.7.4925 Boehringer Ingelheim Investigational Site
city: Leipzig
country: Germany
facility: 1062.7.4931 Boehringer Ingelheim Investigational Site
city: Leverkusen
country: Germany
facility: 1062.7.4907 Boehringer Ingelheim Investigational Site
city: Ludwigsburg
country: Germany
facility: 1062.7.4942 Boehringer Ingelheim Investigational Site
city: Ludwigsfelde
country: Germany
facility: 1062.7.4906 Boehringer Ingelheim Investigational Site
city: Ludwigshafen
country: Germany
facility: 1062.7.4941 Boehringer Ingelheim Investigational Site
city: Lüdenscheid
country: Germany
facility: 1062.7.4922 Boehringer Ingelheim Investigational Site
city: Lüdenscheid
country: Germany
facility: 1062.7.4930 Boehringer Ingelheim Investigational Site
city: Lützen
country: Germany
facility: 1062.7.4911 Boehringer Ingelheim Investigational Site
city: Marburg
country: Germany
facility: 1062.7.4916 Boehringer Ingelheim Investigational Site
city: Marl
country: Germany
facility: 1062.7.4948 Boehringer Ingelheim Investigational Site
city: Oelde
country: Germany
facility: 1062.7.4921 Boehringer Ingelheim Investigational Site
city: Offenbach
country: Germany
facility: 1062.7.4935 Boehringer Ingelheim Investigational Site
city: Potsdam
country: Germany
facility: 1062.7.4903 Boehringer Ingelheim Investigational Site
city: Recklinghausen
country: Germany
facility: 1062.7.4937 Boehringer Ingelheim Investigational Site
city: Reichenbach
country: Germany
facility: 1062.7.4956 Boehringer Ingelheim Investigational Site
city: Saarbrücken
country: Germany
facility: 1062.7.4905 Boehringer Ingelheim Investigational Site
city: Salzkotten
country: Germany
facility: 1062.7.4933 Boehringer Ingelheim Investigational Site
city: Stendal
country: Germany
facility: 1062.7.4943 Boehringer Ingelheim Investigational Site
city: Stuhr
country: Germany
facility: 1062.7.4955 Boehringer Ingelheim Investigational Site
city: Thedinghausen
country: Germany
facility: 1062.7.4957 Boehringer Ingelheim Investigational Site
city: Wallerfing
country: Germany
facility: 1062.7.4913 Boehringer Ingelheim Investigational Site
city: Wardenburg
country: Germany
facility: 1062.7.4924 Boehringer Ingelheim Investigational Site
city: Wiesbaden
country: Germany
facility: 1062.7.4914 Boehringer Ingelheim Investigational Site
city: Winsen
country: Germany
facility: 1062.7.4901 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: