Sodium Picosulphate vs. Placebo in Functional Constipation

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00576810
First received: October 29, 2007
Last updated: April 30, 2014
Last verified: April 2014

October 29, 2007
April 30, 2014
October 2007
January 2009   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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.
Complete list of historical versions of study NCT00576810 on ClinicalTrials.gov Archive Site
  • 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) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Number of spontaneous bowel movements (SBMs) per week after the first intake of the study medication [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Time to first SBM following the first intake of the study medication [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Number of patients with an increase of ≥ 1 CSBM per week compared with the last 7 days of the baseline period [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Number of patients with ≥ 1 CSBM a day [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Number of patients with ≥ 3 CSBMs per week [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Number of premature withdrawals [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Number of patients who have used rescue medication [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in mean score per week for constipation symptoms [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in the patients' score per week for overall satisfaction with bowel habits and bothersomeness of constipation symptoms [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Final global assessment of efficacy by the investigator (good, satisfactory, not satisfactory, bad) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Final global assessment of efficacy by the patient (good, satisfactory, not satisfactory, bad) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Quality of Life (SF-36v2and PAC-QOL) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Blood pressure [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Number of participants with abnormal serum electrolyte laboratory parameters [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
  • Number of participants with abnormal serum chemistry laboratory parameters [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Final global assessment of tolerability by the investigator (good, satisfactory, not satisfactory, bad) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Final global assessment of tolerability by the patient (good, satisfactory, not satisfactory, bad) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Sodium Picosulphate vs. Placebo in Functional Constipation
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

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

Not Provided
Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Constipation
Drug: sodium picosulphate
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
367
Not Provided
January 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00576810
1062.7, EURDRACT2007-002087-10
Not Provided
Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP