Dulcolax vs Placebo in Functional Constipation

This study has been completed.

Sponsor:

Information provided by:

Boehringer Ingelheim Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00526097

First received: September 5, 2007

Last updated: May 18, 2012

Last verified: May 2012

History of Changes

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

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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

[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

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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

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1. Primary:

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

Show Outcome Measure 1

2. Secondary:

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

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3. Secondary:

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

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4. Secondary:

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

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5. Secondary:

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

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6. Secondary:

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

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7. Secondary:

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

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8. Secondary:

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

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9. Secondary:

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

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10. Secondary:

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

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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19. Secondary:

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

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20. Secondary:

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

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21. Secondary:

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

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22. Secondary:

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

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23. Secondary:

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

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24. Secondary:

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

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25. Secondary:

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

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26. Secondary:

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

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27. Secondary:

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

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28. Secondary:

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

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

Show Outcome Measure 47

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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

Show Outcome Measure 54

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 ]

Show Outcome Measure 55

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 ]

Show Outcome Measure 56

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 ]

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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 ]

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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 ]

Show Outcome Measure 59

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 ]

Show Outcome Measure 60

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 ]

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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 ]

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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 ]

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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 ]

Show Outcome Measure 64

65. Secondary:

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

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66. Secondary:

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

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67. Secondary:

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

Show Outcome Measure 67

68. Secondary:

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

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69. Secondary:

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

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70. Secondary:

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

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71. Secondary:

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

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72. Secondary:

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

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73. Secondary:

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

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74. Secondary:

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

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75. Secondary:

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

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76. Secondary:

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

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77. Secondary:

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

Show Outcome Measure 77

78. Secondary:

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

Show Outcome Measure 78

79. Secondary:

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

Show Outcome Measure 79

80. Secondary:

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

Show Outcome Measure 80

81. Secondary:

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

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82. Secondary:

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

Show Outcome Measure 82

83. Secondary:

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

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84. Secondary:

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

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85. Secondary:

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

Show Outcome Measure 85

86. Secondary:

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

Show Outcome Measure 86

Serious Adverse Events

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Other Adverse Events

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.

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
No text entered.

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:	May 18, 2012
Health Authority:	Great Britain: MHRA

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