A randomised, double -blind, placebo-controlled, parallel group study to assess the efficacy and safety of 4 weeks treatment with sodium picosulphate [Dulcolax®, Laxoberal®] drops 10 mg administered orally, once daily, in patients with functional constipation.
- Conditions
- To compare the efficacy and safety of 4 weeks treatment with sodium picosulphate [Dulcolax®, Laxoberal®] drops to placebo in patients with functional constipationMedDRA version: 9.1Level: LLTClassification code 10010774Term: Constipation
- Registration Number
- EUCTR2007-002087-10-DE
- Lead Sponsor
- Boehringer Ingelheim Pharma GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
3.3.1 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 (Appendix 10.3), i.e.:
Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to
diagnosis.
a. Must include 2 or more of the following:
o straining during at least 25% of the defecations
o lumpy or hard stools in at least 25% of the defecations
o sensation of incomplete evacuation for at least 25% of the defecations
o sensation of anorectal obstruction/blockade for at least 25% of the
defecations
o manual manoeuvres to facilitate at least 25% of the defecations (e.g. digital
evacuation, support of the pelvic floor)
o fewer than 3 defecations per week
b. Loose stools are rarely present without the use of laxatives
c. 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 [Dulcolax®]
suppositories)
5. Signed and dated written informed consent prior to enrolment into the study in
accordance with GCP and local legislation
At Visit 2 (i.e. at the end of the baseline period), patients must comply with the following
additional inclusion criteria to be eligible for entry into the treatment phase:
6. Functional constipation is confirmed by e-diary data at the end of the baseline period,
according to the following definition:
a. An average of less than 3 CSBMs per week, together with at least one of the
following symptoms occurring at least 25% of the time:
o straining
o incomplete evacuation
o lumpy or hard stools (i.e. type 1 or type 2 stools according to the 7-point
Bristol Stool Form Scale, see Appendix 10.4)
7. Compliant with the use of the e-diary throughout the baseline period (compliance is
defined as completing 80% of the e-diary evening reports, see Section 5.1.1.1)
8. Compliant with the use of the trial rescue medication (i.e. 10 mg bisacodyl
[Dulcolax®] suppositories) throughout the baseline period. Compliance is defined as
follows:
o rescue medication may be used if there has not been a bowel movement for more
than 72 hours
o rescue medication may not be used on either day -1 or on the day of randomisation
(day 1)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
3.3.2 Exclusion criteria
At the screening visit (Visit 1), patients must not comply with any of the following exclusion
criteria to be eligible for entry into the baseline period:
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 interferewith 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 [Dulcolax®, Laxoberal®] and
matching placebo drops, bisacodyl [Dulcolax®] 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 discont inue 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:
i. are nursing (breast-feeding) or who are pregnant OR
ii. 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.
Acceptable methods of birth control include:
1. transdermal patch
2. intra-uterine devices/systems (IUDs/IUSs)
3. oral, implantable or injectable contraceptives
4. sexual abstinence
5. sterilisation or a vasectomised partner
13. Participation 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
At Visit 2 (i.e. at the end of the baseline period), patients must not comply with any of the
following additional exclusion criteria if they are to remain eligible for entry into the
treatment phase:
16. Clinically significant abnormal electrolyte values identified following the central
laboratory analysis at the screening visit (Visit 1)
17. Loose or watery stools (i.e. type 6 or type 7 according to the 7-point Bristol Stool
Form Scale, see Appendix 10.4) for a total of 3 days or more during the baseline
period
18. Persons committed to an institution following an order issued by either the judicial or administrative authorities (cf. section 40, para 1, clause 3 No. 4 German Medicines Act.)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The objective of the study is to compare the efficacy and safety of 4 weeks treatment with sodium picosulphate (Laxoberal®, Dulcolax®) drops 10 mg to placebo in patients with functional constipation.;Secondary Objective: In addition, the effect of treatment on quality of life and general health status will also be<br>evaluated<br><br><br>;Primary end point(s): 2.2 PRIMARY ENDPOINT(S)<br>The primary endpoint in this trial is the mean number of complete spontaneous bowel<br>movements (CSBMs) per week, during the 4 week treatment phase of the trial.<br>A spontaneous bowel movement (SBM) is defined as a non rescue medication induced stool,<br>a CSBM is defined as a SBM with a sensation of complete evacuation:
- Secondary Outcome Measures
Name Time Method