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Dulcolax vs Placebo in Functional Constipation
This study is currently recruiting participants.
Verified by Boehringer Ingelheim Pharmaceuticals, April 2009
First Received: September 5, 2007   Last Updated: April 23, 2009   History of Changes
Sponsored by: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00526097
  Purpose

The objective of the study is to compare the efficacy and safety of 4 weeks treatment with bisacodyl (Dulcolax) tablets 10 mg 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: bisacodyl
Phase III

MedlinePlus related topics: Constipation
Drug Information available for: Bisacodyl Bisacodyl tannex
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Parallel Assignment, Safety/Efficacy Study
Official Title: A Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Long-Term Treatment (4 Weeks) With Bisacodyl Tablets 10mg Administered Orally, Once Daily, in Patients With Functional Constipation.

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

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 ]

Secondary Outcome Measures:
  • CSBMs and SBM related endpoints Quality of Life SF 36v2 and PAC QOL Final global assessment of efficacy and tolerability by patient and investigator Serum electrolyte and chemistry laboratory parameters [ Time Frame: per week, per day, 4 weeks ]

Estimated Enrollment: 360
Study Start Date: September 2007
Estimated Primary Completion Date: May 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 , i.e.: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)
  3. Able and willing to complete a daily e-diary
  4. Able and willing to use the trial rescue medication
  5. Signed and dated written informed consent prior to enrolment into the study in accordance with GCP and local legislation

    At Visit 2, patients must comply with the following additional inclusion criteria to be eligible for entry into the treatment phase:

  6. Functional constipation is confirmed by e-diary data at the end of the baseline period:

    a. An average of less than 3 CSBMs per week, together with at least one of the following symptoms occurring at least 25% of the time:

    • straining
    • incomplete evacuation
    • lumpy or hard stools (i.e. type 1 or type 2 stools)
  7. Compliant with the use of the e-diary throughout the baseline period (compliance is defined as completing 80% of the evening reports)
  8. Compliant with the use of rescue medication throughout the baseline period. Compliance is defined as follows:

    • rescue medication may be used if there has not been a bowel movement for more than 72 hrs rescue medication may not be used on either day -1 or on the day of randomisation (day 1)

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 bisacodyl or any other ingredient in the study medication
  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
  12. Pre-menopausal women who:

    1. are nursing (breast-feeding) or who are pregnant OR
    2. 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. Acceptable methods of birth control include:

      • transdermal patch
      • intra-uterine devices/systems (IUDs/IUSs)
      • oral, implantable or injectable contraceptives
      • sexual abstinence
      • sterilisation or a vasectomised partner
  13. Participation in another trial with an investigational product with 1 month of enrolment into this study
  14. Drug or alcohol abuse
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00526097

Contacts
Contact: Boehringer Ingelheim Study Coordinator 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

Locations
United Kingdom
122.56.44002 Boehringer Ingelheim Investigational Site Completed
Edgbaston, Birmingham, United Kingdom
122.56.44003 Boehringer Ingelheim Investigational Site Completed
Cardiff, United Kingdom
122.56.44004 Boehringer Ingelheim Investigational Site Completed
Glasgow, United Kingdom
122.56.44005 Boehringer Ingelheim Investigational Site Completed
Manchester, United Kingdom
122.56.44006 Boehringer Ingelheim Investigational Site Completed
Chorley, United Kingdom
122.56.44007 Boehringer Ingelheim Investigational Site Completed
Liverpool, United Kingdom
122.56.44008 Boehringer Ingelheim Investigational Site Completed
Wolverhampton, United Kingdom
122.56.44009 Boehringer Ingelheim Investigational Site Completed
Bennetthorpe, Doncaster, United Kingdom
122.56.44010 Boehringer Ingelheim Investigational Site Completed
Midsomer Norton, United Kingdom
122.56.44001 Boehringer Ingelheim Investigational Site Active, not recruiting
Slough, United Kingdom
122.56.44012 Boehringer Ingelheim Investigational Site Recruiting
Blackpool, United Kingdom
122.56.44015 Boehringer Ingelheim Investigational Site Active, not recruiting
Warminster, United Kingdom
122.56.44017 Boehringer Ingelheim Investigational Site Recruiting
Chesterfield, United Kingdom
122.56.44024 Boehringer Ingelheim Investigational Site Active, not recruiting
Burbage, United Kingdom
122.56.44033 Boehringer Ingelheim Investigational Site Recruiting
Dundee, United Kingdom
122.56.44014 Boehringer Ingelheim Investigational Site Completed
Chippenham, United Kingdom
122.56.44023 Boehringer Ingelheim Investigational Site Completed
Atherstone, United Kingdom
122.56.44025 Boehringer Ingelheim Investigational Site Active, not recruiting
Bexhill, United Kingdom
122.56.44026 Boehringer Ingelheim Investigational Site Active, not recruiting
Sunbury-on-Thames, United Kingdom
122.56.44016 Boehringer Ingelheim Investigational Site Recruiting
Bath, United Kingdom
122.56.44018 Boehringer Ingelheim Investigational Site Recruiting
Ash Vale, Aldershot, United Kingdom
122.56.44019 Boehringer Ingelheim Investigational Site Active, not recruiting
Swindon, United Kingdom
122.56.44020 Boehringer Ingelheim Investigational Site Recruiting
Leamington Spa, United Kingdom
122.56.44021 Boehringer Ingelheim Investigational Site Active, not recruiting
Newtonabbey, United Kingdom
122.56.44022 Boehringer Ingelheim Investigational Site Recruiting
Paignton, United Kingdom
122.56.44011 Boehringer Ingelheim Investigational Site Recruiting
Bedworth, United Kingdom
122.56.44031 Boehringer Ingelheim Investigational Site Recruiting
Fowey, United Kingdom
122.56.44032 Boehringer Ingelheim Investigational Site Completed
Addlestone, United Kingdom
122.56.44029 Boehringer Ingelheim Investigational Site Active, not recruiting
Ashford, United Kingdom
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers: 122.56, EUDRACT 2007-001991-34
Study First Received: September 5, 2007
Last Updated: April 23, 2009
ClinicalTrials.gov Identifier: NCT00526097     History of Changes
Health Authority: Great Britain: MHRA

Study placed in the following topic categories:
Signs and Symptoms
Laxatives
Signs and Symptoms, Digestive
Constipation
Cathartics
Bisacodyl

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

ClinicalTrials.gov processed this record on May 07, 2009