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
Results First Received: May 27, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double-Blind;   Primary Purpose: Treatment
Condition: Constipation
Interventions: Drug: Bisacodyl 10 mg
Drug: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were partly recruited by commercial research centers and partly by general practitioners.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants were randomised into the treatment period only, when functional constipation and compliance with rescue medication were confirmed by eDiary data in the two-weeks baseline period without study medication.

Reporting Groups
  Description
Placebo Two bisacodyl-matching 5 mg placebo tablets once daily
Bisacodyl Two bisacodyl 5 mg tablets once daily

Participant Flow:   Overall Study
    Placebo     Bisacodyl  
STARTED     121 [1]   247 [1]
COMPLETED     106 [2]   191 [2]
NOT COMPLETED     15     56  
Adverse Event                 6                 44  
Protocol Violation                 4                 10  
Withdrawal by Subject                 3                 1  
Other                 2                 1  
[1] Started: Participant was randomised and took at least one dose of randomised study medication
[2] Completed: Participant without premature discontinuation in the randomised treatment period



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Two bisacodyl-matching 5 mg placebo tablets once daily
Bisacodyl Two bisacodyl 5 mg tablets once daily
Total Total of all reporting groups

Baseline Measures
    Placebo     Bisacodyl     Total  
Number of Participants  
[units: participants]
  121     247     368  
Age  
[units: Years]
Mean ± Standard Deviation
  54.7  ± 15.1     55.8  ± 15.9     55.4  ± 15.6  
Gender  
[units: Participants]
     
Female     96     179     275  
Male     25     68     93  
Baseline assessment regarding the bothersomeness with abdominal bloating [1]
[units: Participants]
     
Not at all bothersome     12     21     33  
Hardly bothersome     20     33     53  
Moderately bothersome     40     85     125  
A good deal bothersome     36     60     96  
A very great deal bothersome     12     47     59  
Missing assessment     1     1     2  
Baseline assessment regarding the bothersomeness with abdominal discomfort [1]
[units: Participants]
     
Not at all bothersome     14     26     40  
Hardly bothersome     22     40     62  
Moderately bothersome     47     91     138  
A good deal bothersome     31     64     95  
A very great deal bothersome     6     25     31  
Missing assessment     1     1     2  
Baseline assessment regarding the bothersomeness with constipation [1]
[units: Participants]
     
Not at all bothersome     6     15     21  
Hardly bothersome     5     19     24  
Moderately bothersome     57     91     148  
A good deal bothersome     41     88     129  
A very great deal bothersome     11     33     44  
Missing assessment     1     1     2  
Baseline assessment regarding the overall satisfaction with bowel habits [2]
[units: Participants]
     
A very great deal satisfied     3     10     13  
A good deal satisfied     3     9     12  
Moderately satisfied     41     74     115  
Hardly satisfied     44     93     137  
Not at all satisfied     29     60     89  
Missing assessment     1     1     2  
Baseline for dimension 'Bodily pain (BP)' of the SF-36 QoL scale [3]
[units: Score on a scale]
Mean ± Standard Deviation
  68.5  ± 24.3     67.5  ± 26.0     67.8  ± 25.4  
Baseline for dimension 'General health (GH)' of the SF-36 QoL scale [4]
[units: Score on a scale]
Mean ± Standard Deviation
  68.0  ± 21.1     69.9  ± 20.6     69.3  ± 20.7  
Baseline for dimension 'Mental health (MH)' of the SF-36 QoL scale [5]
[units: Score on a scale]
Mean ± Standard Deviation
  74.2  ± 18.0     77.0  ± 16.8     76.1  ± 17.2  
Baseline for dimension 'Physical functioning (PF)' of the SF-36v2™ (SF-36) Quality of Life (QoL) [6]
[units: Score on a scale]
Mean ± Standard Deviation
  79.2  ± 24.3     80.1  ± 24.6     79.8  ± 24.5  
Baseline for dimension 'Role limitation due to emotional problems (RE)' of the SF-36 QoL scale [7]
[units: Score on a scale]
Mean ± Standard Deviation
  82.7  ± 24.7     86.3  ± 22.3     85.1  ± 23.1  
Baseline for dimension 'Role limitation due to physical problems (RP)' of the SF-36 QoL scale [8]
[units: Score on a scale]
Mean ± Standard Deviation
  79.7  ± 25.2     80.6  ± 25.6     80.3  ± 25.5  
Baseline for dimension 'Social functioning (SF)' of the SF-36 QoL scale [3]
[units: Score on a scale]
Mean ± Standard Deviation
  83.4  ± 21.6     86.0  ± 20.9     85.1  ± 21.2  
Baseline for dimension 'Vitality (VT)' of the SF-36 QoL scale [8]
[units: Score on a scale]
Mean ± Standard Deviation
  55.7  ± 20.2     58.9  ± 21.0     57.9  ± 20.8  
Baseline for the Mental Component Scale (MCS) of the SF-36 QoL scale [9]
[units: Score on a scale]
Mean ± Standard Deviation
  49.0  ± 11.0     51.1  ± 9.8     50.4  ± 10.3  
Baseline for the Physical Component Scale (PCS) of the SF-36 QoL scale [10]
[units: Score on a scale]
Mean ± Standard Deviation
  48.7  ± 9.4     48.3  ± 9.8     48.5  ± 9.7  
Baseline mean score for constipation symptom 'Sensation of incomplete evacuation' [11]
[units: Score on a scale]
Mean ± Standard Deviation
  0.7  ± 0.3     0.7  ± 0.3     0.7  ± 0.3  
Baseline mean score for constipation symptom 'Manual manoeuvre' [12]
[units: Score on a scale]
Mean ± Standard Deviation
  0.2  ± 0.4     0.2  ± 0.3     0.2  ± 0.3  
Baseline mean score for constipation symptom 'Anorectal obstructions/blockade' [13]
[units: Score on a scale]
Mean ± Standard Deviation
  1.2  ± 1.0     1.2  ± 1.0     1.2  ± 1.0  
Baseline mean score for constipation symptom 'Stool quality' [14]
[units: Score on a scale]
Mean ± Standard Deviation
  2.4  ± 1.2     2.5  ± 1.3     2.4  ± 1.3  
Baseline mean score for constipation symptom 'Straining' [13]
[units: Score on a scale]
Mean ± Standard Deviation
  1.9  ± 0.9     1.8  ± 0.8     1.9  ± 0.8  
Baseline number of Complete Spontaneous Bowel Movements (CSBMs) [15]
[units: CSBMs per week]
Mean ± Standard Deviation
  1.0  ± 1.1     1.1  ± 1.2     1.1  ± 1.2  
Baseline number of Spontaneous Bowel Movements (SBMs) [16]
[units: SBMs per week]
Mean ± Standard Deviation
  4.2  ± 2.6     4.4  ± 3.9     4.3  ± 3.6  
Baseline overall score (OSC) of PAC-QoL [17]
[units: Score on a scale]
Mean ± Standard Deviation
  1.8  ± 0.6     1.8  ± 0.7     1.8  ± 0.7  
Baseline subscore 'Physical discomfort (PHD)' of PAC-QoL [18]
[units: Score on a scale]
Mean ± Standard Deviation
  1.9  ± 0.8     2.0  ± 0.9     2.0  ± 0.9  
Baseline subscore 'Psychosocial discomfort (PSD)' of PAC-QoL [19]
[units: Score on a scale]
Mean ± Standard Deviation
  0.8  ± 0.8     0.9  ± 0.8     0.9  ± 0.8  
Baseline subscore 'Satisfaction (SAT)' of PAC-QoL [18]
[units: Score on a scale]
Mean ± Standard Deviation
  3.0  ± 0.7     2.8  ± 0.8     2.9  ± 0.8  
Baseline subscore'Worries and concerns (WCC)' of Patient Assessment of Constipation-QoL(PAC-QoL) [19]
[units: Score on a scale]
Mean ± Standard Deviation
  1.4  ± 0.8     1.5  ± 0.9     1.4  ± 0.9  
Baseline value for chloride (normalized value) [20]
[units: mmol/L]
Mean ± Standard Deviation
  104.0  ± 2.33     103.7  ± 2.85     103.8  ± 2.69  
Baseline value for potassium (normalized value) [21]
[units: mmol/L]
Mean ± Standard Deviation
  4.2  ± 0.33     4.2  ± 0.33     4.2  ± 0.33  
Baseline value for sodium (normalized value) [20]
[units: mmol/L]
Mean ± Standard Deviation
  139.5  ± 2.13     139.3  ± 2.30     139.4  ± 2.24  
[1] Baseline assessment was made at the end of the last week of the baseline period without study medication using a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome)
[2] Baseline assessment was made at the end of the last week of the baseline period without study medication using a 5-point ordinal verbal rating scale (VRS): 0 (A very great deal satisfied) to 4 (Not at all satisfied)
[3] 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.
[4] 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. (Placebo: N=119, Bisacodyl: N=245)
[5] 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.
[6] 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.
[7] 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.
[8] 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.
[9] 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. (Placebo: N=119, Bisacodyl: N=245)
[10] 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. (Placebo: N=119, Bisacodyl: N=245)
[11] 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 last week of the baseline period without study medication (Placebo: N=120, Bisacodyl: N=240).
[12] 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 last week of the baseline period without study medication (Placebo: N=116, Bisacodyl: N=231).
[13] 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 last week of the baseline period without study medication. (Placebo: N=116, Bisacodyl: N=231)
[14] 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 last week of the baseline period without study medication. (Placebo: N=116, Bisacodyl: N=231)
[15] Complete Spontaneous Bowel Movement (CSBM): complete non-rescue medication-induced BM; Baseline number of CSBMs is defined by the number of CSBMs during the last week of the baseline period without study medication
[16] Spontaneous BM (SBM): non-rescue medication-induced BM; Baseline number of SBMs is defined by the number of SBMs during the last week of the baseline period without study medication
[17] 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 (Placebo: N=119, Bisacodyl: N=245)
[18] 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 (Placebo: N=120, Bisacodyl: N=245)
[19] 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 (Placebo: N=121, Bisacodyl: N=245)
[20] 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 (Placebo: N=120, Bisacodyl: N=245)
[21] 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 (Placebo: N=120, Bisacodyl: N=244)



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Mean Number of Complete Spontaneous Bowel Movements (CSBMs) Per Week Over the 4 Weeks Treatment Period   [ Time Frame: 4 Weeks ]

2.  Secondary:   Number of CSBMs at Week 1   [ Time Frame: Week 1 in treatment period ]

3.  Secondary:   Number of CSBMs at Week 2   [ Time Frame: Week 2 in treatment period ]

4.  Secondary:   Number of CSBMs at Week 3   [ Time Frame: Week 3 in treatment period ]

5.  Secondary:   Number of CSBMs at Week 4   [ Time Frame: Week 4 in treatment period ]

6.  Secondary:   Mean Number of SBMs Per Week Over the 4 Weeks Treatment Period   [ Time Frame: 4 Weeks ]

7.  Secondary:   Number of SBMs at Week 1   [ Time Frame: Week 1 in treatment period ]

8.  Secondary:   Number of SBMs at Week 2   [ Time Frame: Week 2 in treatment period ]

9.  Secondary:   Number of SBMs at Week 3   [ Time Frame: Week 3 in treatment period ]

10.  Secondary:   Number of SBMs at Week 4   [ Time Frame: Week 4 in treatment period ]

11.  Secondary:   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 ]

12.  Secondary:   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 ]

13.  Secondary:   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 ]

14.  Secondary:   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 ]

15.  Secondary:   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 ]

16.  Secondary:   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 ]

17.  Secondary:   Number of Participants With a Mean of at Least 1 CSBM a Day Over the 4 Weeks Treatment Period   [ Time Frame: 4 weeks ]

18.  Secondary:   Number of Participants With a Mean of at Least 3 CSBMs a Week Over the 4 Weeks Treatment Period   [ Time Frame: 4 weeks ]

19.  Secondary:   Number of Premature Withdrawals Over the 4 Weeks Treatment Period   [ Time Frame: 4 weeks ]

20.  Secondary:   Number of Premature Withdrawals at Week 1 in the Treatment Period   [ Time Frame: Week 1 in the treatment period ]

21.  Secondary:   Number of Premature Withdrawals at Week 2 in the Treatment Period   [ Time Frame: Week 2 in the treatment period ]

22.  Secondary:   Number of Premature Withdrawals at Week 3 in the Treatment Period   [ Time Frame: Week 3 in the treatment period ]

23.  Secondary:   Number of Premature Withdrawals at Week 4 in the Treatment Period   [ Time Frame: Week 4 in the treatment period ]

24.  Secondary:   Number of Participants Using Rescue Medication Over the 4 Weeks Treatment Period   [ Time Frame: 4 weeks ]

25.  Secondary:   Number of Participants Using Rescue Medication at Week 1 in the Treatment Period   [ Time Frame: Week 1 in the treatment period ]

26.  Secondary:   Number of Participants Using Rescue Medication at Week 2 in the Treatment Period   [ Time Frame: Week 2 in the treatment period ]

27.  Secondary:   Number of Participants Using Rescue Medication at Week 3 in the Treatment Period   [ Time Frame: Week 3 in the treatment period ]

28.  Secondary:   Number of Participants Using Rescue Medication at Week 4 in the Treatment Period   [ Time Frame: Week 4 in the treatment period ]

29.  Secondary:   Change From Baseline in the Mean Score for Constipation Symptom 'Straining' at Week 1   [ Time Frame: Baseline and week 1 in treatment period ]

30.  Secondary:   Change From Baseline in the Mean Score for Constipation Symptom 'Straining' at Week 2   [ Time Frame: Baseline and week 2 in treatment period ]

31.  Secondary:   Change From Baseline in the Mean Score for Constipation Symptom 'Straining' at Week 3   [ Time Frame: Baseline and week 3 in treatment period ]

32.  Secondary:   Change From Baseline in the Mean Score for Constipation Symptom 'Straining' at Week 4   [ Time Frame: Baseline and week 4 in treatment period ]

33.  Secondary:   Change From Baseline in the Mean Score for Constipation Symptom 'Stool Quality' at Week 1   [ Time Frame: Baseline and week 1 in treatment period ]

34.  Secondary:   Change From Baseline in the Mean Score for Constipation Symptom 'Stool Quality' at Week 2   [ Time Frame: Baseline and week 2 in treatment period ]

35.  Secondary:   Change From Baseline in the Mean Score for Constipation Symptom 'Stool Quality' at Week 3   [ Time Frame: Baseline and week 3 in treatment period ]

36.  Secondary:   Change From Baseline in the Mean Score for Constipation Symptom 'Stool Quality' at Week 4   [ Time Frame: Baseline and week 4 in treatment period ]

37.  Secondary:   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 ]

38.  Secondary:   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 ]

39.  Secondary:   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 ]

40.  Secondary:   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 ]

41.  Secondary:   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 ]

42.  Secondary:   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 ]

43.  Secondary:   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 ]

44.  Secondary:   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 ]

45.  Secondary:   Change From Baseline in the Mean Score for Constipation Symptom 'Manual Manoeuvre' at Week 1   [ Time Frame: Baseline and week 1 in treatment period ]

46.  Secondary:   Change From Baseline in the Mean Score for Constipation Symptom 'Manual Manoeuvre' at Week 2   [ Time Frame: Baseline and week 2 in treatment period ]

47.  Secondary:   Change From Baseline in the Mean Score for Constipation Symptom 'Manual Manoeuvre' at Week 3   [ Time Frame: Baseline and week 3 in treatment period ]

48.  Secondary:   Change From Baseline in the Mean Score for Constipation Symptom 'Manual Manoeuvre' at Week 4   [ Time Frame: Baseline and week 4 in treatment period ]

49.  Secondary:   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 ]

50.  Secondary:   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 ]

51.  Secondary:   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 ]

52.  Secondary:   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 ]

53.  Secondary:   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 ]

54.  Secondary:   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 ]

55.  Secondary:   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 ]

56.  Secondary:   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 ]

57.  Secondary:   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 ]

58.  Secondary:   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 ]

59.  Secondary:   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 ]

60.  Secondary:   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 ]

61.  Secondary:   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 ]

62.  Secondary:   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 ]

63.  Secondary:   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 ]

64.  Secondary:   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 ]

65.  Secondary:   Number of Participants With Respect to the Final Global Assessment of Efficacy by the Investigator   [ Time Frame: 4 weeks ]

66.  Secondary:   Number of Participants With Respect to the Final Global Assessment of Efficacy by the Patient   [ Time Frame: 4 weeks ]

67.  Secondary:   Number of Participants With Respect to the Final Global Assessment of Tolerability by the Investigator   [ Time Frame: 4 weeks ]

68.  Secondary:   Number of Participants With Respect to the Final Global Assessment of Tolerability by the Patient   [ Time Frame: 4 weeks ]

69.  Secondary:   Change From Baseline in the SF-36 Dimension 'Physical Functioning'   [ Time Frame: Baseline and 4 weeks ]

70.  Secondary:   Change From Baseline in the SF-36 Dimension 'Role Limitation Due to Physical Problems'   [ Time Frame: Baseline and 4 weeks ]

71.  Secondary:   Change From Baseline in the SF-36 Dimension 'Bodily Pain'   [ Time Frame: Baseline and 4 weeks ]

72.  Secondary:   Change From Baseline in the SF-36 Dimension 'General Health'   [ Time Frame: Baseline and 4 weeks ]

73.  Secondary:   Change From Baseline in the SF-36 Dimension 'Vitality'   [ Time Frame: Baseline and 4 weeks ]

74.  Secondary:   Change From Baseline in the SF-36 Dimension 'Social Functioning'   [ Time Frame: Baseline and 4 weeks ]

75.  Secondary:   Change From Baseline in the SF-36 Dimension 'Role Limitation Due to Emotional Problems'   [ Time Frame: Baseline and 4 weeks ]

76.  Secondary:   Change From Baseline in the SF-36 Dimension 'Mental Health'   [ Time Frame: Baseline and 4 weeks ]

77.  Secondary:   Change From Baseline in the SF-36 Mental Component Scale (MCS)   [ Time Frame: Baseline and 4 weeks ]

78.  Secondary:   Change From Baseline in the SF-36 Physical Component Scale (PCS)   [ Time Frame: Baseline and 4 weeks ]

79.  Secondary:   Change From Baseline in the PAC-QoL Subscale 'Worries and Concerns'   [ Time Frame: Baseline and 4 weeks ]

80.  Secondary:   Change From Baseline in the PAC-QoL Subscale 'Physical Discomfort'   [ Time Frame: Baseline and 4 weeks ]

81.  Secondary:   Change From Baseline in the PAC-QoL Subscale 'Psychosocial Discomfort'   [ Time Frame: Baseline and 4 weeks ]

82.  Secondary:   Change From Baseline in the PAC-QoL Subscale 'Satisfaction'   [ Time Frame: Baseline and 4 weeks ]

83.  Secondary:   Change From Baseline in the PAC-QoL Overall Score   [ Time Frame: Baseline and 4 weeks ]

84.  Secondary:   Change From Baseline for Sodium (Normalized Value)   [ Time Frame: Baseline and 4 weeks ]

85.  Secondary:   Change From Baseline for Potassium (Normalized Value)   [ Time Frame: Baseline and 4 weeks ]

86.  Secondary:   Change From Baseline for Chloride (Normalized Value)   [ Time Frame: Baseline and 4 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com


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