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
  Purpose

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


Condition Intervention Phase
Constipation
Drug: sodium picosulphate
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 367
Study Start Date: October 2007
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00576810

Locations
Germany
1062.7.4926 Boehringer Ingelheim Investigational Site
Amberg, Germany
1062.7.4918 Boehringer Ingelheim Investigational Site
Bad Essen, Germany
1062.7.4946 Boehringer Ingelheim Investigational Site
Bergkamen, Germany
1062.7.4929 Boehringer Ingelheim Investigational Site
Berlin, Germany
1062.7.4904 Boehringer Ingelheim Investigational Site
Berlin, Germany
1062.7.4902 Boehringer Ingelheim Investigational Site
Blankenhain, Germany
1062.7.4927 Boehringer Ingelheim Investigational Site
Dortmund, Germany
1062.7.4954 Boehringer Ingelheim Investigational Site
Dortmund, Germany
1062.7.4949 Boehringer Ingelheim Investigational Site
Dresden, Germany
1062.7.4950 Boehringer Ingelheim Investigational Site
Einbeck, Germany
1062.7.4909 Boehringer Ingelheim Investigational Site
Freising, Germany
1062.7.4923 Boehringer Ingelheim Investigational Site
Fürth, Germany
1062.7.4912 Boehringer Ingelheim Investigational Site
Hagen, Germany
1062.7.4953 Boehringer Ingelheim Investigational Site
Hamburg, Germany
1062.7.4910 Boehringer Ingelheim Investigational Site
Hannover, Germany
1062.7.4920 Boehringer Ingelheim Investigational Site
Herne, Germany
1062.7.4944 Boehringer Ingelheim Investigational Site
Ingelheim, Germany
1062.7.4936 Boehringer Ingelheim Investigational Site
Jena, Germany
1062.7.4925 Boehringer Ingelheim Investigational Site
Leipzig, Germany
1062.7.4931 Boehringer Ingelheim Investigational Site
Leipzig, Germany
1062.7.4907 Boehringer Ingelheim Investigational Site
Leverkusen, Germany
1062.7.4942 Boehringer Ingelheim Investigational Site
Ludwigsburg, Germany
1062.7.4906 Boehringer Ingelheim Investigational Site
Ludwigsfelde, Germany
1062.7.4941 Boehringer Ingelheim Investigational Site
Ludwigshafen, Germany
1062.7.4930 Boehringer Ingelheim Investigational Site
Lüdenscheid, Germany
1062.7.4922 Boehringer Ingelheim Investigational Site
Lüdenscheid, Germany
1062.7.4911 Boehringer Ingelheim Investigational Site
Lützen, Germany
1062.7.4916 Boehringer Ingelheim Investigational Site
Marburg, Germany
1062.7.4948 Boehringer Ingelheim Investigational Site
Marl, Germany
1062.7.4921 Boehringer Ingelheim Investigational Site
Oelde, Germany
1062.7.4935 Boehringer Ingelheim Investigational Site
Offenbach, Germany
1062.7.4903 Boehringer Ingelheim Investigational Site
Potsdam, Germany
1062.7.4937 Boehringer Ingelheim Investigational Site
Recklinghausen, Germany
1062.7.4956 Boehringer Ingelheim Investigational Site
Reichenbach, Germany
1062.7.4905 Boehringer Ingelheim Investigational Site
Saarbrücken, Germany
1062.7.4933 Boehringer Ingelheim Investigational Site
Salzkotten, Germany
1062.7.4943 Boehringer Ingelheim Investigational Site
Stendal, Germany
1062.7.4955 Boehringer Ingelheim Investigational Site
Stuhr, Germany
1062.7.4957 Boehringer Ingelheim Investigational Site
Thedinghausen, Germany
1062.7.4913 Boehringer Ingelheim Investigational Site
Wallerfing, Germany
1062.7.4924 Boehringer Ingelheim Investigational Site
Wardenburg, Germany
1062.7.4914 Boehringer Ingelheim Investigational Site
Wiesbaden, Germany
1062.7.4901 Boehringer Ingelheim Investigational Site
Winsen, Germany
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00576810     History of Changes
Other Study ID Numbers: 1062.7, EURDRACT2007-002087-10
Study First Received: October 29, 2007
Last Updated: April 30, 2014
Health Authority: Germany: Bundesinstitut fuer Arzneimittel und Medizinprodukte (BfArM)

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms
Picosulfate sodium
Cathartics
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014