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Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
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Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00526097 |
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 |
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. |
Estimated Enrollment: | 360 |
Study Start Date: | September 2007 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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.
Must include 2 or more of the following::
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:
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:
Compliant with the use of rescue medication throughout the baseline period. Compliance is defined as follows:
Exclusion Criteria:
Pre-menopausal women who:
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:
Contact: Boehringer Ingelheim Study Coordinator | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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 |
Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
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 |
Signs and Symptoms Laxatives Signs and Symptoms, Digestive |
Constipation Cathartics Bisacodyl |
Signs and Symptoms Signs and Symptoms, Digestive Therapeutic Uses Gastrointestinal Agents |
Constipation Cathartics Bisacodyl Pharmacologic Actions |