Dulcolax vs Placebo in Functional Constipation

Boehringer Ingelheim368 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

368

Conditions

Constipation

Interventions

Bisacodyl 10 mgDRUG

2 x 5 mg bisacodyl once daily

PlaceboDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (27)

Outcomes

Primary Outcomes

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.

Time frame: 4 Weeks

Secondary Outcomes

Number of CSBMs at Week 1

The number of CSBMs at week 1 was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer.

Time frame: Week 1 in treatment period

Number of CSBMs at Week 2

The number of CSBMs at week 2 was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer.

Time frame: Week 2 in treatment period

Number of CSBMs at Week 3

The number of CSBMs at week 3 was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer.

Time frame: Week 3 in treatment period

Number of CSBMs at Week 4

The number of CSBMs at week 4 was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer.

Time frame: Week 4 in treatment period

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

A Spontaneous Bowel Movement (SBM) is a non-rescue medication-induced stool. The number of SBMs 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.

Data from ClinicalTrials.gov

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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

...and 17 more locations

Number of SBMs at Week 1

The number of SBMs at week 1 was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer.

Time frame: Week 1 in treatment period

Number of SBMs at Week 2

The number of SBMs at week 2 was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer.

Time frame: Week 2 in treatment period

Number of SBMs at Week 3

The number of SBMs at week 3 was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer.

Time frame: Week 3 in treatment period

Number of SBMs at Week 4

The number of SBMs at week 4 was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer.

Time frame: Week 4 in treatment period

Time to the First SBM Following the First Dose of Study Medication (SM)

The time to the first SBM following the first dose of SM was captured by the eDiary. The time was censored by the time of intake of rescue medication (RM), the time of premature discontinuation or the end of treatment whatever was minimal.

Time frame: Time of first dose of SM up to 4 weeks

Number of Participants With an Increase of at Least 1 in the Mean Number of CSBMs Per Week Over the 4 Weeks Treatment Period Compared to Baseline

Time frame: Baseline and 4 weeks

Number of Participants With an Increase of at Least 1 CSBM at Week 1 Compared to Baseline

Time frame: Baseline and week 1 in treatment period

Number of Participants With an Increase of at Least 1 CSBM at Week 2 Compared to Baseline

Time frame: Baseline and week 2 in treatment period

Number of Participants With an Increase of at Least 1 CSBM at Week 3 Compared to Baseline

Time frame: Baseline and week 3 in treatment period

Number of Participants With an Increase of at Least 1 CSBM at Week 4 Compared to Baseline

Time frame: Baseline and week 4 in treatment period

Number of Participants With a Mean of at Least 1 CSBM a Day Over the 4 Weeks Treatment Period

Time frame: 4 weeks

Number of Participants With a Mean of at Least 3 CSBMs a Week Over the 4 Weeks Treatment Period

Time frame: 4 weeks

Number of Premature Withdrawals Over the 4 Weeks Treatment Period

Time frame: 4 weeks

Number of Premature Withdrawals at Week 1 in the Treatment Period

Time frame: Week 1 in the treatment period

Number of Premature Withdrawals at Week 2 in the Treatment Period

Time frame: Week 2 in the treatment period

Number of Premature Withdrawals at Week 3 in the Treatment Period

Time frame: Week 3 in the treatment period

Number of Premature Withdrawals at Week 4 in the Treatment Period

Time frame: Week 4 in the treatment period

Number of Participants Using Rescue Medication Over the 4 Weeks Treatment Period

Time frame: 4 weeks

Number of Participants Using Rescue Medication at Week 1 in the Treatment Period

Time frame: Week 1 in the treatment period

Number of Participants Using Rescue Medication at Week 2 in the Treatment Period

Time frame: Week 2 in the treatment period

Number of Participants Using Rescue Medication at Week 3 in the Treatment Period

Time frame: Week 3 in the treatment period

Number of Participants Using Rescue Medication at Week 4 in the Treatment Period

Time frame: Week 4 in the treatment period

Change From Baseline in the Mean Score for Constipation Symptom 'Straining' at Week 1

The score on a 5-point ordinal verbal rating scale from 0 (absent) to 4 (very severe) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.

Time frame: Baseline and week 1 in treatment period

Change From Baseline in the Mean Score for Constipation Symptom 'Straining' at Week 2

Time frame: Baseline and week 2 in treatment period

Change From Baseline in the Mean Score for Constipation Symptom 'Straining' at Week 3

Time frame: Baseline and week 3 in treatment period

Change From Baseline in the Mean Score for Constipation Symptom 'Straining' at Week 4

Time frame: Baseline and week 4 in treatment period

Change From Baseline in the Mean Score for Constipation Symptom 'Stool Quality' at Week 1

The score on the 7-point Bristol Stool Form Scale from Type 1 (hard, lumpy stool) to Type 7 (watery stool) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.

Time frame: Baseline and week 1 in treatment period

Change From Baseline in the Mean Score for Constipation Symptom 'Stool Quality' at Week 2

Time frame: Baseline and week 2 in treatment period

Change From Baseline in the Mean Score for Constipation Symptom 'Stool Quality' at Week 3

Time frame: Baseline and week 3 in treatment period

Change From Baseline in the Mean Score for Constipation Symptom 'Stool Quality' at Week 4

Time frame: Baseline and week 4 in treatment period

Change From Baseline in the Mean Score for Constipation Symptom 'Sensation of Incomplete Evacuation' at Week 1

The score on a 2-point ordinal verbal rating scale from 0 (no) to 1 (yes) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.

Time frame: Baseline and week 1 in treatment period

Change From Baseline in the Mean Score for Constipation Symptom 'Sensation of Incomplete Evacuation' at Week 2

Time frame: Baseline and week 2 in treatment period

Change From Baseline in the Mean Score for Constipation Symptom 'Sensation of Incomplete Evacuation' at Week 3

Time frame: Baseline and week 3 in treatment period

Change From Baseline in the Mean Score for Constipation Symptom 'Sensation of Incomplete Evacuation' at Week 4

Time frame: Baseline and week 4 in treatment period

Change From Baseline in the Mean Score for Constipation Symptom 'Anorectal Obstructions/Blockade' at Week 1

Time frame: Baseline and week 1 in treatment period

Change From Baseline in the Mean Score for Constipation Symptom 'Anorectal Obstructions/Blockade' at Week 2

Time frame: Baseline and week 2 in treatment period

Change From Baseline in the Mean Score for Constipation Symptom 'Anorectal Obstructions/Blockade' at Week 3

Time frame: Baseline and week 3 in treatment period

Change From Baseline in the Mean Score for Constipation Symptom 'Anorectal Obstructions/Blockade' at Week 4

Time frame: Baseline and week 4 in treatment period

Change From Baseline in the Mean Score for Constipation Symptom 'Manual Manoeuvre' at Week 1

Time frame: Baseline and week 1 in treatment period

Change From Baseline in the Mean Score for Constipation Symptom 'Manual Manoeuvre' at Week 2

Time frame: Baseline and week 2 in treatment period

Change From Baseline in the Mean Score for Constipation Symptom 'Manual Manoeuvre' at Week 3

Time frame: Baseline and week 3 in treatment period

Change From Baseline in the Mean Score for Constipation Symptom 'Manual Manoeuvre' at Week 4

Time frame: Baseline and week 4 in treatment period

Number of Participants With Improved, Unchanged or Worsened Overall Satisfaction With Bowel Habits at Week 1 in the Treatment Period in Comparison to Baseline

Improved / unchanged / worsened overall satisfaction is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (A very great deal satisfied) to 4 (Not at all satisfied) at the corresponding week in comparison to baseline

Time frame: Baseline and week 1 in the treatment period

Number of Participants With Improved, Unchanged or Worsened Overall Satisfaction With Bowel Habits at Week 2 in the Treatment Period in Comparison to Baseline

Time frame: Baseline and week 2 in the treatment period

Number of Participants With Improved, Unchanged or Worsened Overall Satisfaction With Bowel Habits at Week 3 in the Treatment Period in Comparison to Baseline

Time frame: Baseline and week 3 in the treatment period

Number of Participants With Improved, Unchanged or Worsened Overall Satisfaction With Bowel Habits at Week 4 in the Treatment Period in Comparison to Baseline

Time frame: Baseline and week 4 in the treatment period

Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Constipation at Week 1 in the Treatment Period in Comparison to Baseline

Reduced / unchanged / increased bothersomeness of constipation is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline

Time frame: Baseline and week 1 in the treatment period

Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Constipation at Week 2 in the Treatment Period in Comparison to Baseline

Time frame: Baseline and week 2 in the treatment period

Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Constipation at Week 3 in the Treatment Period in Comparison to Baseline

Time frame: Baseline and week 3 in the treatment period

Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Constipation at Week 4 in the Treatment Period in Comparison to Baseline

Time frame: Baseline and week 4 in the treatment period

Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Bloating at Week 1 in the Treatment Period in Comparison to Baseline

Reduced / unchanged / increased bothersomeness of abdominal bloating is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline

Time frame: Baseline and week 1 in the treatment period

Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Bloating at Week 2 in the Treatment Period in Comparison to Baseline

Time frame: Baseline and week 2 in the treatment period

Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Bloating at Week 3 in the Treatment Period in Comparison to Baseline

Time frame: Baseline and week 3 in the treatment period

Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Bloating at Week 4 in the Treatment Period in Comparison to Baseline

Time frame: Baseline and week 4 in the treatment period

Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Discomfort at Week 1 in the Treatment Period in Comparison to Baseline

Reduced / unchanged / increased bothersomeness of abdominal discomfort is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline

Time frame: Baseline and week 1 in the treatment period

Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Discomfort at Week 2 in the Treatment Period in Comparison to Baseline

Time frame: Baseline and week 2 in the treatment period

Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Discomfort at Week 3 in the Treatment Period in Comparison to Baseline

Time frame: Baseline and week 3 in the treatment period

Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Discomfort at Week 4 in the Treatment Period in Comparison to Baseline

Time frame: Baseline and week 4 in the treatment period

Number of Participants With Respect to the Final Global Assessment of Efficacy by the Investigator

Final global assessment scale range: 1 (good) to 4 (bad), ordinal

Time frame: 4 weeks

Number of Participants With Respect to the Final Global Assessment of Efficacy by the Patient

Final global assessment scale range: 1 (good) to 4 (bad), ordinal

Time frame: 4 weeks

Number of Participants With Respect to the Final Global Assessment of Tolerability by the Investigator

Final global assessment scale range: 1 (good) to 4 (bad), ordinal

Time frame: 4 weeks

Number of Participants With Respect to the Final Global Assessment of Tolerability by the Patient

Final global assessment scale range: 1 (good) to 4 (bad), ordinal

Time frame: 4 weeks

Change From Baseline in the SF-36 Dimension 'Physical Functioning'

The dimension is a sum of 10 single items and then transferred to a scale ranging from 0 to 100. Single item scores are inverted, if applicable, to ensure that a higher score indicates a better health.

Time frame: Baseline and 4 weeks

Change From Baseline in the SF-36 Dimension 'Role Limitation Due to Physical Problems'

The dimension is a sum of 4 single items and then transferred to a scale ranging from 0 to 100. Single item scores are inverted, if applicable, to ensure that a higher score indicates a better health.

Time frame: Baseline and 4 weeks

Change From Baseline in the SF-36 Dimension 'Bodily Pain'

The dimension is a sum of 2 single items and then transferred to a scale ranging from 0 to 100. Single item scores are inverted, if applicable, to ensure that a higher score indicates a better health.

Time frame: Baseline and 4 weeks

Change From Baseline in the SF-36 Dimension 'General Health'

The dimension is a sum of 5 single items and then transferred to a scale ranging from 0 to 100. Single item scores are inverted, if applicable, to ensure that a higher score indicates a better health.

Time frame: Baseline and 4 weeks

Change From Baseline in the SF-36 Dimension 'Vitality'

Time frame: Baseline and 4 weeks

Change From Baseline in the SF-36 Dimension 'Social Functioning'

Time frame: Baseline and 4 weeks

Change From Baseline in the SF-36 Dimension 'Role Limitation Due to Emotional Problems'

The dimension is a sum of 3 single items and then transferred to a scale ranging from 0 to 100. Single item scores are inverted, if applicable, to ensure that a higher score indicates a better health.

Time frame: Baseline and 4 weeks

Change From Baseline in the SF-36 Dimension 'Mental Health'

Time frame: Baseline and 4 weeks

Change From Baseline in the SF-36 Mental Component Scale (MCS)

The MCS is a summary scale of the dimensions vitality, social functioning, role-emotional, and mental health. The component scale is norm-based to a standard population. A higher score indicates a better health.

Time frame: Baseline and 4 weeks

Change From Baseline in the SF-36 Physical Component Scale (PCS)

The PCS is a summary scale of the subscales physical functioning, role-physical, bodily pain, and general health. The component scale is norm-based to a standard population. A higher score indicates a better health.

Time frame: Baseline and 4 weeks

Change From Baseline in the PAC-QoL Subscale 'Worries and Concerns'

The PAC-QoL is a 28-item (5-point Likert scale ranging from 0 (none of the time or not at all) to 4 (all of the time or extremely). Single item scores are inverted, if applicable, to ensure that a lower score indicates a better QoL

Time frame: Baseline and 4 weeks

Change From Baseline in the PAC-QoL Subscale 'Physical Discomfort'

Time frame: Baseline and 4 weeks

Change From Baseline in the PAC-QoL Subscale 'Psychosocial Discomfort'

Time frame: Baseline and 4 weeks

Change From Baseline in the PAC-QoL Subscale 'Satisfaction'

Time frame: Baseline and 4 weeks

Change From Baseline in the PAC-QoL Overall Score

Time frame: Baseline and 4 weeks

Change From Baseline for Sodium (Normalized Value)

Normalized value: the reported laboratory value is converted by linear transformation to a preferred unit and then linear-transformed with respect to the standard reference range

Time frame: Baseline and 4 weeks

Change From Baseline for Potassium (Normalized Value)

Normalized value: the reported laboratory value is converted by linear transformation to a preferred unit and then linear-transformed with respect to the standard reference range

Time frame: Baseline and 4 weeks

Change From Baseline for Chloride (Normalized Value)

Normalized value: the reported laboratory value is converted by linear transformation to a preferred unit and then linear-transformed with respect to the standard reference range

Time frame: Baseline and 4 weeks