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History of Changes for Study: NCT00526097
Dulcolax vs Placebo in Functional Constipation
Latest version (submitted December 13, 2013) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 September 5, 2007 None (earliest Version on record)
2 November 12, 2007 Recruitment Status, Contacts/Locations, Study Status, Eligibility and Oversight
3 December 18, 2007 Study Status and Oversight
4 January 31, 2008 Study Status and Contacts/Locations
5 March 5, 2008 Study Status, Eligibility, Study Description, Oversight and Study Identification
6 March 27, 2008 Study Status, Study Identification, Eligibility and Oversight
7 April 25, 2008 Contacts/Locations, Study Status, Eligibility and Oversight
8 June 10, 2008 Contacts/Locations, Study Status, Study Design, Outcome Measures, Eligibility, Arms and Interventions, Sponsor/Collaborators and Study Identification
9 July 25, 2008 Contacts/Locations and Study Status
10 October 22, 2008 Contacts/Locations, Study Status, Eligibility and Arms and Interventions
11 October 23, 2008 Eligibility and Study Status
12 November 24, 2008 Contacts/Locations, Study Status, Eligibility and Oversight
13 December 11, 2008 Contacts/Locations, Study Status, Eligibility and Oversight
14 March 5, 2009 Contacts/Locations and Study Status
15 April 23, 2009 Study Status and Contacts/Locations
16 May 28, 2009 Recruitment Status, Study Status and Contacts/Locations
17 June 24, 2009 Recruitment Status, Study Status, Study Design and Contacts/Locations
18 July 12, 2010 Study Status, Arms and Interventions, Outcome Measures, Study Design, Results, Eligibility, Study Description and Study Identification
19 August 25, 2010 Outcome Measures, Baseline Characteristics, Study Status and References
20 September 1, 2010 Study Status and References
21 May 18, 2012 Study Status and References
22 December 13, 2013 Study Status, Adverse Events, Baseline Characteristics and Participant Flow
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Study NCT00526097
Submitted Date:  November 12, 2007 (v2)

Open or close this module Study Identification
Unique Protocol ID: 122.56
Brief Title: Dulcolax vs Placebo in Functional Constipation
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.
Secondary IDs:
Open or close this module Study Status
Record Verification: November 2007
Overall Status: Recruiting
Study Start:
Primary Completion:
Study Completion: April 2009
First Submitted: September 5, 2007
First Submitted that
Met QC Criteria:
September 5, 2007
First Posted: September 6, 2007 [Estimate]
Last Update Submitted that
Met QC Criteria:
November 12, 2007
Last Update Posted: November 14, 2007 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Boehringer Ingelheim
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
Brief Summary: 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.
Detailed Description:

This randomised, double-blind, placebo-controlled, parallel group study will assess the efficacy and safety of 4 weeks treatment with bisacodyl (Dulcolax?) tablets 10 mg administered orally, once daily, in patients suffering from functional constipation.

Male and female patients with functional constipation, as defined by the Rome III diagnostic criteria (see Appendix 10.3), will initially be screened against the trial entry criteria. Eligible patients will immediately enter a 2 week baseline period without study medication throughout which they will be instructed to use an electronic Patient Reported Outcome (e-PRO) device (i.e. an electronic(e)-diary) to record information relating to their constipation. Patients whose functional constipation is confirmed by the e-diary data from the baseline period, and who are compliant with both its use and that of the rescue medication, will be randomised into a 4 week double-blind treatment phase. During this phase of the trial, patients will receive either bisacodyl (Dulcolax?) tablets (two 5 mg tablets) or matching placebo in a 2:1 ratio. The study medication will be administered orally, once daily (in the evening) and patients will be instructed to continue using the e-diary throughout the 4 week treatment phase. They will be instructed to return for further study visits on 2 occasions (i.e. on day 16 and day 30). Dose reduction (to one 5 mg tablet) and subsequent titration back up to the original dose of two 5 mg tablets will be permitted throughout the treatment phase of the trial.

Rescue medication, in the form of 10 mg bisacodyl (Dulcolax?) suppositories, will be provided to the patient upon entry into the baseline period for use, as required, throughout the 6 week duration of the trial. Patients who do not experience a bowel movement for more than 72 hours will be informed that they may use the bisacodyl (Dulcolax?) suppositories which are for rectal use only. A maximum dose of 10 mg will be permitted. Use of rescue medication will not be permitted on day -1 nor on the day of randomisation (day 1).

Approximately 450 patients will be enrolled into this UK-based trial. Approximately 15 trial sites are anticipated to participate to ensure 360 patients are randomised in a 2:1 ratio to study medication (240 to bisacodyl [Dulcolax?] and 120 to matching placebo). Trial sites are expected to be a mixture of commercial Site Management Organisation (SMO) sites and General Practitioners, but could also include Gastroenterologists.

The Co-ordinating Investigator, who, amongst others, will have responsibility for sign-off of both the Clinical Trial Protocol (CTP) and Clinical Trial Report (CTR), will be selected by Boehringer Ingelheim and will be a Gastroenterologist. It is not anticipated that the Co-ordinating Investigator will be one of the sites participating in the trial.

Enrolment of patients into the trial will be competitive i.e. enrolment will stop at all sites as soon as 360 patients have been randomised. Sites will be notified as soon as enrolment is complete. Patients who are in the screening/baseline period at the time of this notification will be allowed to continue in the study if they meet the trial entry criteria.

Analysis of laboratory samples (blood) will be performed by a central laboratory.

All trial relevant documentation will be stored by Boehringer Ingelheim in the clinical trial master file (CTMF). Trial relevant documentation held by the trial sites will be filed in the ISF.

Enrolment of patients into the trial will be competitive i.e. enrolment will stop at all sites as soon as 360 patients have been randomised. Sites will be notified as soon as enrolment is complete. Patients who are in the screening/baseline period at the time of this notification will be allowed to continue in the study if they meet the trial entry criteria.

Analysis of laboratory samples (blood) will be performed by a central laboratory.

Study Hypothesis:

It will be tested whether a statistically significant difference exists in the mean number of CSBMs per week over the 4 weeks of treatment between the group treated with bisacodyl (Dulcolax?) tablets and the group treated with placebo tablets. To this purpose the following statements will be hypothesised:

Null hypothesis There is no difference between the group treated with bisacodyl (Dulcolax?) tablets and the group treated with placebo tablets with respect to the mean number of CSBMs per week over the 4 weeks of treatment.

Alternative hypothesis There is a difference between the group treated with bisacodyl (Dulcolax?) tablets and the group treated with placebo tablets with respect to the mean number of CSBMs per week over the 4 weeks of treatment.

The statistical tests will be carried out two-sided. The significance level will be set at 0.05.

Comparison(s):

The design of this study is double-blind, randomised, placebo-controlled and parallel group. Patients will be selected by means of the Rome III diagnostic criteria and will undergo a baseline period without treatment prior to randomisation. Each of these design choices are fully supported for the design of treatment trials for functional gastrointestinal disorders, such as functional constipation, that is being investigated here. Furthermore, the double-blind, randomised controlled clinical trial with parallel group design is the accepted standard for evaluation of efficacy for the vast majority of treatments.

A placebo control group is an essential requirement for intervention studies of functional gastrointestinal disorders, as no treatment can be considered the current standard of care. The placebo response can also be very high (e.g. up to 70%) in these trials making it more difficult to demonstrate superiority of a treatment over placebo. Furthermore, a placebo control is the preference of the Rome Committee and is required by the American College of Gastroenterology Chronic Constipation Task Force.

The (2 week) baseline period without treatment has been included to evaluate patient eligibility prior to randomisation. It will ensure that all patients reaching randomisation are currently symptomatic and meet the pre-defined definition of functional constipation ? in a disorder such as constipation, which is likely to have fluctuating symptoms, this is an important consideration. Hence, it is assured that the patients in the two treatment groups in this trial (bisacodyl and placebo) will be comparable in this respect.

A minimum treatment duration of 4 weeks is recommended for treatment trials for functional gastrointestinal disorders, and is considered appropriate for this trial when taking into account the fluctuating nature of functional constipation and the corresponding intermittent treatment of the disease.

Open or close this module Conditions
Conditions: Constipation
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms:
Masking: Double (masked roles unspecified)
Allocation: Randomized
Enrollment: 360
Open or close this module Arms and Interventions
Intervention Details:
Drug: bisacodyl
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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.
Secondary Outcome Measures:
1. 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
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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.

    a. Must include 2 or more of the following::

    o straining during at least 25% of the defecations

    o lumpy or hard stools in at least 25% of the defecations

    o sensation of incomplete evacuation for at least 25% of the defecations

    o 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 b. Loose stools are rarely present without the use of laxatives c. 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:

    o 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)

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
Open or close this module Contacts/Locations
Central Contact Person: Boehringer Ingelheim Study Coordinator
Email: clintriage@rdg.boehringer-ingelheim.com
Study Officials: Boehringer Ingelheim Study Coordinator
Study Chair
Boehringer Ingelheim Ltd./Bracknell
Locations: United Kingdom
Boehringer Ingelheim Investigational Site
[Recruiting]
Birmingham, United Kingdom, B15 2SQ
Boehringer Ingelheim Investigational Site
[Recruiting]
Cardiff, United Kingdom, CF14 5GJ
Boehringer Ingelheim Investigational Site
[Recruiting]
Chorley, United Kingdom, PR7 7NA
Boehringer Ingelheim Investigational Site
[Recruiting]
Glasgow, United Kingdom, G81 2DR
Boehringer Ingelheim Investigational Site
[Recruiting]
Liverpool, United Kingdom, L22 0LG
Boehringer Ingelheim Investigational Site
[Recruiting]
Manchester, United Kingdom, M15 6SX
Boehringer Ingelheim Investigational Site
[Recruiting]
Slough, United Kingdom, SL1 2AD
Boehringer Ingelheim Investigational Site
[Recruiting]
Wolverhampton, United Kingdom, WV10 9RU
Open or close this module IPDSharing
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Open or close this module References
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Available IPD/Information:

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