Sodium Picosulphate vs. Placebo in Functional Constipation

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Constipation

Intervention / Treatment
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* Drug: sodium picosulphate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Parallel Assignment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: sodium picosulphate|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Number of spontaneous bowel movements (SBMs) per week after the first intake of the study medication |  | 4 weeks | 
| Time to first SBM following the first intake of the study medication |  | 4 weeks | 
| Number of patients with an increase of ≥ 1 CSBM per week compared with the last 7 days of the baseline period |  | 4 weeks | 
| Number of patients with ≥ 1 CSBM a day |  | 4 weeks | 
| Number of patients with ≥ 3 CSBMs per week |  | 4 weeks | 
| Number of premature withdrawals |  | 4 weeks | 
| Number of patients who have used rescue medication |  | 4 weeks | 
| Change from baseline in mean score per week for constipation symptoms |  | 4 weeks | 
| Change from baseline in the patients' score per week for overall satisfaction with bowel habits and bothersomeness of constipation symptoms |  | 4 weeks | 
| Final global assessment of efficacy by the investigator (good, satisfactory, not satisfactory, bad) |  | 4 weeks | 
| Final global assessment of efficacy by the patient (good, satisfactory, not satisfactory, bad) |  | 4 weeks | 
| Quality of Life (SF-36v2and PAC-QOL) |  | 4 weeks | 
| Blood pressure |  | 4 weeks | 
| Number of participants with abnormal serum electrolyte laboratory parameters |  | 4 weeks | 
| Number of participants with abnormal serum chemistry laboratory parameters |  | 4 weeks | 
| Final global assessment of tolerability by the investigator (good, satisfactory, not satisfactory, bad) |  | 4 weeks | 
| Final global assessment of tolerability by the patient (good, satisfactory, not satisfactory, bad) |  | 4 weeks |