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Dulcolax vs Placebo in Functional Constipation

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00526097
First received: September 5, 2007
Last updated: December 13, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Constipation
Drug: Bisacodyl 10 mg
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy and Safety of 4 Weeks Treatment With Bisacodyl (Dulcolax) Tablets 10mg Administered Orally, Once Daily, in Patients With Functional Constipation.

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Mean Number of Complete Spontaneous Bowel Movements (CSBMs) Per Week Over the 4 Weeks Treatment Period [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Number of CSBMs at Week 1 [ Time Frame: Week 1 in treatment period ] [ Designated as safety issue: No ]
    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.

  • Number of CSBMs at Week 2 [ Time Frame: Week 2 in treatment period ] [ Designated as safety issue: No ]
    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.

  • Number of CSBMs at Week 3 [ Time Frame: Week 3 in treatment period ] [ Designated as safety issue: No ]
    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.

  • Number of CSBMs at Week 4 [ Time Frame: Week 4 in treatment period ] [ Designated as safety issue: No ]
    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.

  • Mean Number of SBMs Per Week Over the 4 Weeks Treatment Period [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
    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.

  • Number of SBMs at Week 1 [ Time Frame: Week 1 in treatment period ] [ Designated as safety issue: No ]
    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.

  • Number of SBMs at Week 2 [ Time Frame: Week 2 in treatment period ] [ Designated as safety issue: No ]
    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.

  • Number of SBMs at Week 3 [ Time Frame: Week 3 in treatment period ] [ Designated as safety issue: No ]
    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.

  • Number of SBMs at Week 4 [ Time Frame: Week 4 in treatment period ] [ Designated as safety issue: No ]
    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 to the First SBM Following the First Dose of Study Medication (SM) [ Time Frame: Time of first dose of SM up to 4 weeks ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Number of Participants With a Mean of at Least 1 CSBM a Day Over the 4 Weeks Treatment Period [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Number of Participants With a Mean of at Least 3 CSBMs a Week Over the 4 Weeks Treatment Period [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Number of Premature Withdrawals Over the 4 Weeks Treatment Period [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Number of Premature Withdrawals at Week 1 in the Treatment Period [ Time Frame: Week 1 in the treatment period ] [ Designated as safety issue: No ]
  • Number of Premature Withdrawals at Week 2 in the Treatment Period [ Time Frame: Week 2 in the treatment period ] [ Designated as safety issue: No ]
  • Number of Premature Withdrawals at Week 3 in the Treatment Period [ Time Frame: Week 3 in the treatment period ] [ Designated as safety issue: No ]
  • Number of Premature Withdrawals at Week 4 in the Treatment Period [ Time Frame: Week 4 in the treatment period ] [ Designated as safety issue: No ]
  • Number of Participants Using Rescue Medication Over the 4 Weeks Treatment Period [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Number of Participants Using Rescue Medication at Week 1 in the Treatment Period [ Time Frame: Week 1 in the treatment period ] [ Designated as safety issue: No ]
  • Number of Participants Using Rescue Medication at Week 2 in the Treatment Period [ Time Frame: Week 2 in the treatment period ] [ Designated as safety issue: No ]
  • Number of Participants Using Rescue Medication at Week 3 in the Treatment Period [ Time Frame: Week 3 in the treatment period ] [ Designated as safety issue: No ]
  • Number of Participants Using Rescue Medication at Week 4 in the Treatment Period [ Time Frame: Week 4 in the treatment period ] [ Designated as safety issue: No ]
  • Change From Baseline in the Mean Score for Constipation Symptom 'Straining' at Week 1 [ Time Frame: Baseline and week 1 in treatment period ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in the Mean Score for Constipation Symptom 'Straining' at Week 2 [ Time Frame: Baseline and week 2 in treatment period ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in the Mean Score for Constipation Symptom 'Straining' at Week 3 [ Time Frame: Baseline and week 3 in treatment period ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in the Mean Score for Constipation Symptom 'Straining' at Week 4 [ Time Frame: Baseline and week 4 in treatment period ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in the Mean Score for Constipation Symptom 'Stool Quality' at Week 1 [ Time Frame: Baseline and week 1 in treatment period ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in the Mean Score for Constipation Symptom 'Stool Quality' at Week 2 [ Time Frame: Baseline and week 2 in treatment period ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in the Mean Score for Constipation Symptom 'Stool Quality' at Week 3 [ Time Frame: Baseline and week 3 in treatment period ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in the Mean Score for Constipation Symptom 'Stool Quality' at Week 4 [ Time Frame: Baseline and week 4 in treatment period ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in the Mean Score for Constipation Symptom 'Sensation of Incomplete Evacuation' at Week 1 [ Time Frame: Baseline and week 1 in treatment period ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in the Mean Score for Constipation Symptom 'Manual Manoeuvre' at Week 1 [ Time Frame: Baseline and week 1 in treatment period ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in the Mean Score for Constipation Symptom 'Manual Manoeuvre' at Week 2 [ Time Frame: Baseline and week 2 in treatment period ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in the Mean Score for Constipation Symptom 'Manual Manoeuvre' at Week 3 [ Time Frame: Baseline and week 3 in treatment period ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in the Mean Score for Constipation Symptom 'Manual Manoeuvre' at Week 4 [ Time Frame: Baseline and week 4 in treatment period ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With Improved, Unchanged or Worsened Overall Satisfaction With Bowel Habits at Week 1 in the Treatment Period in Comparison to Baseline [ Time Frame: Baseline and week 1 in the treatment period ] [ Designated as safety issue: No ]
    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

  • 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 ] [ Designated as safety issue: No ]
    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

  • 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 ] [ Designated as safety issue: No ]
    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

  • 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 ] [ Designated as safety issue: No ]
    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

  • Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Constipation at Week 1 in the Treatment Period in Comparison to Baseline [ Time Frame: Baseline and week 1 in the treatment period ] [ Designated as safety issue: No ]
    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

  • 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 ] [ Designated as safety issue: No ]
    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

  • 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 ] [ Designated as safety issue: No ]
    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

  • 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 ] [ Designated as safety issue: No ]
    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

  • Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Bloating at Week 1 in the Treatment Period in Comparison to Baseline [ Time Frame: Baseline and week 1 in the treatment period ] [ Designated as safety issue: No ]
    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

  • 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 ] [ Designated as safety issue: No ]
    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

  • 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 ] [ Designated as safety issue: No ]
    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

  • 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 ] [ Designated as safety issue: No ]
    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

  • Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Discomfort at Week 1 in the Treatment Period in Comparison to Baseline [ Time Frame: Baseline and week 1 in the treatment period ] [ Designated as safety issue: No ]
    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

  • 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 ] [ Designated as safety issue: No ]
    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

  • 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 ] [ Designated as safety issue: No ]
    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

  • 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 ] [ Designated as safety issue: No ]
    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

  • Number of Participants With Respect to the Final Global Assessment of Efficacy by the Investigator [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Final global assessment scale range: 1 (good) to 4 (bad), ordinal

  • Number of Participants With Respect to the Final Global Assessment of Efficacy by the Patient [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Final global assessment scale range: 1 (good) to 4 (bad), ordinal

  • Number of Participants With Respect to the Final Global Assessment of Tolerability by the Investigator [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    Final global assessment scale range: 1 (good) to 4 (bad), ordinal

  • Number of Participants With Respect to the Final Global Assessment of Tolerability by the Patient [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    Final global assessment scale range: 1 (good) to 4 (bad), ordinal

  • Change From Baseline in the SF-36 Dimension 'Physical Functioning' [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in the SF-36 Dimension 'Role Limitation Due to Physical Problems' [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in the SF-36 Dimension 'Bodily Pain' [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in the SF-36 Dimension 'General Health' [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in the SF-36 Dimension 'Vitality' [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in the SF-36 Dimension 'Social Functioning' [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in the SF-36 Dimension 'Role Limitation Due to Emotional Problems' [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in the SF-36 Dimension 'Mental Health' [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in the SF-36 Mental Component Scale (MCS) [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in the SF-36 Physical Component Scale (PCS) [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in the PAC-QoL Subscale 'Worries and Concerns' [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
    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

  • Change From Baseline in the PAC-QoL Subscale 'Physical Discomfort' [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
    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

  • Change From Baseline in the PAC-QoL Subscale 'Psychosocial Discomfort' [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
    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

  • Change From Baseline in the PAC-QoL Subscale 'Satisfaction' [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
    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

  • Change From Baseline in the PAC-QoL Overall Score [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
    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

  • Change From Baseline for Sodium (Normalized Value) [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
    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

  • Change From Baseline for Potassium (Normalized Value) [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
    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

  • Change From Baseline for Chloride (Normalized Value) [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
    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


Enrollment: 368
Study Start Date: September 2007
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bisacodyl 5 mg x 2 once daily
patient to receive two enteric-coated tablets containing 5 mg bisacodyl
Drug: Bisacodyl 10 mg
2 x 5 mg bisacodyl once daily
Placebo Comparator: Placebo
patient to receive two placebo-to-match enteric-coated tablets 5 mg bisacodyl
Drug: Placebo
Placebo-to-match bisacodyl 10 mg (2 x 5 mg) once daily

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

    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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00526097

Locations
United Kingdom
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
122.56.44020 Boehringer Ingelheim Investigational Site
Leamington Spa, 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
122.56.44001 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
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00526097     History of Changes
Other Study ID Numbers: 122.56, EUDRACT 2007-001991-34
Study First Received: September 5, 2007
Results First Received: May 27, 2010
Last Updated: December 13, 2013
Health Authority: Great Britain: MHRA

Additional relevant MeSH terms:
Constipation
Signs and Symptoms
Signs and Symptoms, Digestive
Bisacodyl
Cathartics
Gastrointestinal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014