Dulcolax vs Placebo in Functional Constipation

NCT00526097 | Completed Phase 3 Results

• 2 other identifiers: 122.56EUDRACT 2007-001991-34
• Study Type: interventional
• Target: 368
• Locations: 1 country
• Sites: 27

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

Outcome Measures

Primary Outcomes (1)

• Mean Number of Complete Spontaneous Bowel Movements (CSBMs) Per Week Over the 4 Weeks Treatment Period

  A Complete Spontaneous Bowel Movement (CSBM) is a complete non-rescue medication-induced stool. The number of CSBMs in each of the 4 weeks was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer. The sum of the resulting numbers were divided by the number of weeks with data.

  4 Weeks

Secondary Outcomes (85)

• Number of CSBMs at Week 1

  Week 1 in treatment period

• Number of CSBMs at Week 2

  Week 2 in treatment period

• Number of CSBMs at Week 3

  Week 3 in treatment period

• Number of CSBMs at Week 4

  Week 4 in treatment period

• Mean Number of SBMs Per Week Over the 4 Weeks Treatment Period

  4 Weeks

Study Arms (2)

Bisacodyl 5 mg x 2 once daily

EXPERIMENTAL

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

Drug: Bisacodyl 10 mg

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Bisacodyl 10 mg DRUG

2 x 5 mg bisacodyl once daily

Bisacodyl 5 mg x 2 once daily

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients, aged 18 and above
• 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::
• 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
• Loose stools are rarely present without the use of laxatives
• There are insufficient criteria for irritable bowel syndrome (IBS)
• Able and willing to complete a daily e-diary
• Able and willing to use the trial rescue medication
• Signed and dated written informed consent prior to enrolment into the study in accordance with GCP and local legislation
• Functional constipation is confirmed by e-diary data at the end of the baseline period:

You may not qualify if:

• Eating disorders such as anorexia nervosa and bulimia, as a cause of excessive use of laxatives
• Patients whose constipation is caused by primary organic disease of the colon or pelvic floor
• 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
• Patients with restricted mobility (e.g. wheelchair bound, or bed-ridden) that, in the Investigators opinion, would interfere with participation in the trial
• Patients with a known hypersensitivity to bisacodyl or any other ingredient in the study medication
• Patients with ileus, intestinal obstruction, acute surgical abdominal conditions (such as acute appendicitis and acute inflammatory bowel diseases), or severe dehydration
• Patients with anal fissures or ulcerative proctitis with mucosal damage
• Patients with known clinically significant abnormal electrolyte values
• Patients whose concomitant therapy includes an opioid medication (e.g. morphine, codeine)
• Constipation which, in the Investigators opinion, is caused by medication (e.g. anticholinergics)
• Patients who are not willing to discontinue the use of prohibited concomitant therapy
• Pre-menopausal women 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. Acceptable methods of birth control include:
• transdermal patch

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (27)

122.56.44032 Boehringer Ingelheim Investigational Site

Addlestone, United Kingdom

Location

122.56.44018 Boehringer Ingelheim Investigational Site

Ash Vale, Aldershot, United Kingdom

Location

122.56.44029 Boehringer Ingelheim Investigational Site

Ashford, United Kingdom

Location

122.56.44023 Boehringer Ingelheim Investigational Site

Atherstone, United Kingdom

Location

122.56.44011 Boehringer Ingelheim Investigational Site

Bedworth, United Kingdom

Location

122.56.44009 Boehringer Ingelheim Investigational Site

Bennetthorpe, Doncaster, United Kingdom

Location

122.56.44025 Boehringer Ingelheim Investigational Site

Bexhill-on-Sea, United Kingdom

Location

122.56.44012 Boehringer Ingelheim Investigational Site

Blackpool, United Kingdom

Location

122.56.44024 Boehringer Ingelheim Investigational Site

Burbage, United Kingdom

Location

122.56.44003 Boehringer Ingelheim Investigational Site

Cardiff, United Kingdom

Location

122.56.44017 Boehringer Ingelheim Investigational Site

Chesterfield, United Kingdom

Location

122.56.44014 Boehringer Ingelheim Investigational Site

Chippenham, United Kingdom

Location

122.56.44006 Boehringer Ingelheim Investigational Site

Chorley, United Kingdom

Location

122.56.44033 Boehringer Ingelheim Investigational Site

Dundee, United Kingdom

Location

122.56.44002 Boehringer Ingelheim Investigational Site

Edgbaston, Birmingham, United Kingdom

Location

122.56.44004 Boehringer Ingelheim Investigational Site

Glasgow, United Kingdom

Location

122.56.44007 Boehringer Ingelheim Investigational Site

Liverpool, United Kingdom

Location

122.56.44005 Boehringer Ingelheim Investigational Site

Manchester, United Kingdom

Location

122.56.44010 Boehringer Ingelheim Investigational Site

Midsomer Norton, United Kingdom

Location

122.56.44021 Boehringer Ingelheim Investigational Site

Newtonabbey, United Kingdom

Location

122.56.44022 Boehringer Ingelheim Investigational Site

Paignton, United Kingdom

Location

122.56.44020 Boehringer Ingelheim Investigational Site

Royal Leamington Spa, United Kingdom

Location

122.56.44001 Boehringer Ingelheim Investigational Site

Slough, United Kingdom

Location

122.56.44026 Boehringer Ingelheim Investigational Site

Sunbury-on-Thames, United Kingdom

Location

122.56.44019 Boehringer Ingelheim Investigational Site

Swindon, United Kingdom

Location

122.56.44015 Boehringer Ingelheim Investigational Site

Warminster, United Kingdom

Location

122.56.44008 Boehringer Ingelheim Investigational Site

Wolverhampton, United Kingdom

Location

MeSH Terms

Conditions

Constipation

Interventions

Bisacodyl

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cresols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 5, 2007
• First Posted: September 6, 2007
• Study Start: September 1, 2007
• Primary Completion: June 1, 2009
• Last Updated: January 15, 2014
• Results First Posted: August 6, 2010

Record last verified: 2013-12

Locations

GB (27)