Dulcolax vs Placebo in Functional Constipation

NCT ID: NCT00526097

Last Updated: 2014-01-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 368 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30

Brief Summary

The objective of the study was 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 was evaluated.

Conditions

Constipation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Bisacodyl 5 mg x 2 once daily

patient to receive two enteric-coated tablets containing 5 mg bisacodyl

Group Type: EXPERIMENTAL

Bisacodyl 10 mg

Intervention Type: DRUG

2 x 5 mg bisacodyl once daily

Placebo

patient to receive two placebo-to-match enteric-coated tablets 5 mg bisacodyl

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo-to-match bisacodyl 10 mg (2 x 5 mg) once daily

Interventions

Bisacodyl 10 mg

2 x 5 mg bisacodyl once daily

Intervention Type: DRUG

Placebo

Placebo-to-match bisacodyl 10 mg (2 x 5 mg) once daily

Intervention Type: DRUG

Eligibility 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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Boehringer Ingelheim

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

122.56.44032 Boehringer Ingelheim Investigational Site

Addlestone, , United Kingdom

122.56.44018 Boehringer Ingelheim Investigational Site

Ash Vale, Aldershot, , United Kingdom

122.56.44029 Boehringer Ingelheim Investigational Site

Ashford, , United Kingdom

122.56.44023 Boehringer Ingelheim Investigational Site

Atherstone, , United Kingdom

122.56.44011 Boehringer Ingelheim Investigational Site

Bedworth, , United Kingdom

122.56.44009 Boehringer Ingelheim Investigational Site

Bennetthorpe, Doncaster, , United Kingdom

122.56.44025 Boehringer Ingelheim Investigational Site

Bexhill-on-Sea, , United Kingdom

122.56.44012 Boehringer Ingelheim Investigational Site

Blackpool, , United Kingdom

122.56.44024 Boehringer Ingelheim Investigational Site

Burbage, , United Kingdom

122.56.44003 Boehringer Ingelheim Investigational Site

Cardiff, , United Kingdom

122.56.44017 Boehringer Ingelheim Investigational Site

Chesterfield, , United Kingdom

122.56.44014 Boehringer Ingelheim Investigational Site

Chippenham, , United Kingdom

122.56.44006 Boehringer Ingelheim Investigational Site

Chorley, , United Kingdom

122.56.44033 Boehringer Ingelheim Investigational Site

Dundee, , United Kingdom

122.56.44002 Boehringer Ingelheim Investigational Site

Edgbaston, Birmingham, , United Kingdom

122.56.44004 Boehringer Ingelheim Investigational Site

Glasgow, , United Kingdom

122.56.44007 Boehringer Ingelheim Investigational Site

Liverpool, , United Kingdom

122.56.44005 Boehringer Ingelheim Investigational Site

Manchester, , United Kingdom

122.56.44010 Boehringer Ingelheim Investigational Site

Midsomer Norton, , United Kingdom

122.56.44021 Boehringer Ingelheim Investigational Site

Newtonabbey, , United Kingdom

122.56.44022 Boehringer Ingelheim Investigational Site

Paignton, , United Kingdom

122.56.44020 Boehringer Ingelheim Investigational Site

Royal Leamington Spa, , United Kingdom

122.56.44001 Boehringer Ingelheim Investigational Site

Slough, , United Kingdom

122.56.44026 Boehringer Ingelheim Investigational Site

Sunbury-on-Thames, , United Kingdom

122.56.44019 Boehringer Ingelheim Investigational Site

Swindon, , United Kingdom

122.56.44015 Boehringer Ingelheim Investigational Site

Warminster, , United Kingdom

122.56.44008 Boehringer Ingelheim Investigational Site

Wolverhampton, , United Kingdom

Countries

United Kingdom

Other Identifiers

EUDRACT 2007-001991-34

Identifier Type: -

Identifier Source: secondary_id

122.56

Identifier Type: -

Identifier Source: org_study_id