This randomised, double-blind, placebo-controlled, parallel group trial will be conducted in patients with functional constipation MedDRA version: 9.1 Level: LLT Classification code 10010774 Term: Constipation
Conditions
Interventions
Trade Name: Dulcolax Tablets 5mg
Pharmaceutical Form: Gastro-resistant tablet
INN or Proposed INN: Bisacodyl
CAS Number: 603-50-9
Concen
Sponsors
Boehringer Ingelheim Limited
Eligibility
Sex/Gender
All
Inclusion 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 3. Able and willing to complete a daily e-diary 4. Able and willing to use the trial rescue medication (Dulcolax Suppositories 10 mg) 5. Signed and dated written informed consent prior to enrolment into the study in accordance with GCP and local legislation 6. Functional constipation is confirmed by e-diary data at the end of the baseline period 7. Compliant with the use of the e-diary throughout the baseline period (80% of the e-dairy evening reports) 8. Compliant with the use of the trial rescue medication throughout the baseline period. 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
Exclusion criteria
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 bisacodyl or any other ingredient in the study medication, matching placebo tablets and Dulcolax Suppositories 10 mg. 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 fissure or ulcerative proctitis with mucosal damage 8. Patients with known clinically significant abnormal electrolyte values 9. Patients whose concomitant therapy includes an opioid medication 10. Constipation which, in the Investigators' opinion is caused by medication 11. Patients who are not willing to discontinue the use of prohibited concomitant therapy 12. Pre-menopausal women (last menstruation less than or equal to 1 year prior to signing informed consent who : a. are breast-feeding or who are pregnant b. 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 Participation in another trial with an investigational product within 1 month of enrolment into this study 14 Drug or alcohol abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of the study is to compare the efficacy and safety of 4 weeks treatment with bisacodyl (Dulcolax) tablets 10 mg to placebo in patients with functional constipation.;Secondary Objective: The effect of treament on quality of life and general health status will also be evaluated.; Primary end point(s): 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. A spontaneous bowel movement (SBM) is defined as a non rescue medication induced stool, a CSBM is defined as a SBM with a sensation of complete evacuation. | — |
Countries
United Kingdom
Outcome results
None listed