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

Boehringer Ingelheim43 sites in 1 country367 target enrollmentOctober 2007

ConditionsConstipation

Drugssodium picosulphate

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Constipation
Sponsor: Boehringer Ingelheim
Enrollment: 367
Locations: 43
Primary Endpoint: 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.
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

October 2007

End Date

January 2009

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Boehringer Ingelheim

Eligibility Criteria

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

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)

Outcomes

Primary Outcomes

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.

Time Frame: 4 weeks

Secondary Outcomes

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)