Sodium Picosulphate vs. Placebo in Functional Constipation

Constipation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00576810
• Other study ID #: 1062.7
• Secondary ID: EURDRACT2007-002
• Status: Completed
• Phase: Phase 3
• First received: October 29, 2007
• Last updated: April 30, 2014
• Start date: October 2007

Study information

• Verified date: April 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Bundesinstitut fuer Arzneimittel und Medizinprodukte (BfArM)
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 367
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constipation

Intervention

Drug:
• sodium picosulphate

Locations

Country	Name	City	State
Germany	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	Hannover
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	1062.7.4922 Boehringer Ingelheim Investigational Site	Lüdenscheid
Germany	1062.7.4930 Boehringer Ingelheim Investigational Site	Lüdenscheid
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	1062.7.4911 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

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Number of spontaneous bowel movements (SBMs) per week after the first intake of the study medication		4 weeks	No
Secondary	Time to first SBM following the first intake of the study medication		4 weeks	No
Secondary	Number of patients with an increase of = 1 CSBM per week compared with the last 7 days of the baseline period		4 weeks	No
Secondary	Number of patients with = 1 CSBM a day		4 weeks	No
Secondary	Number of patients with = 3 CSBMs per week		4 weeks	No
Secondary	Number of premature withdrawals		4 weeks	No
Secondary	Number of patients who have used rescue medication		4 weeks	No
Secondary	Change from baseline in mean score per week for constipation symptoms		4 weeks	No
Secondary	Change from baseline in the patients' score per week for overall satisfaction with bowel habits and bothersomeness of constipation symptoms		4 weeks	No
Secondary	Final global assessment of efficacy by the investigator (good, satisfactory, not satisfactory, bad)		4 weeks	No
Secondary	Final global assessment of efficacy by the patient (good, satisfactory, not satisfactory, bad)		4 weeks	No
Secondary	Quality of Life (SF-36v2and PAC-QOL)		4 weeks	No
Secondary	Blood pressure		4 weeks	No
Secondary	Number of participants with abnormal serum electrolyte laboratory parameters		4 weeks	Yes
Secondary	Number of participants with abnormal serum chemistry laboratory parameters		4 weeks	No
Secondary	Final global assessment of tolerability by the investigator (good, satisfactory, not satisfactory, bad)		4 weeks	No
Secondary	Final global assessment of tolerability by the patient (good, satisfactory, not satisfactory, bad)		4 weeks	No

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