Sodium Picosulphate vs. Placebo in Functional Constipation

Launched by BOEHRINGER INGELHEIM · Dec 18, 2007

Keywords

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Gender

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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