Sodium Picosulphate vs. Placebo in Functional Constipation

Inclusion criteria

• Male and female patients, aged 18 and above
• 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.

• 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
• Loose stools are rarely present without the use of laxatives
• 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)
• Able and willing to complete a daily e-diary
• Able and willing to use the trial rescue medication (i.e. 10 mg bisacodyl suppositories)
• Signed and dated written informed consent prior to enrolment into the study in accordance with GCP and local legislation

Exclusion criteria

• Eating disorders such as anorexia nervosa and bulimia, as a cause of excessive use of laxatives
• Patients whose constipation is caused by primary organic disease of the colon or pelvic floor
• 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
• Patients with restricted mobility (e.g. wheelchair bound, or bed-ridden) that, in the Investigators opinion, would interfere with participation in the trial
• 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)
• Patients with ileus, intestinal obstruction, acute surgical abdominal conditions (such as acute appendicitis and acute inflammatory bowel diseases), or severe dehydration
• Patients with anal fissures or ulcerative proctitis with mucosal damage
• Patients with known clinically significant abnormal electrolyte values
• Patients whose concomitant therapy includes an opioid medication (e.g. morphine, codeine)
• Constipation which, in the Investigators opinion, is caused by medication (e.g. anticholinergics)
• Patients who are not willing to discontinue the use of prohibited concomitant therapy (see Section 4.2.2)
• 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.
• Participating in another trial with an investigational product with 1 month of enrolment into this study
• Drug or alcohol abuse
• Concomitant use of antibiotics